Premature Birth of NewbornSENSENCT03316547
Supporting and Enhancing NICU Sensory Experiences (SENSE)
A study testing SENSE Program in people with Premature Birth of Newborn, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. Read more about this study
- Who is it for?
- Ages Up to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth of Newborn
- What is being tested?
- SENSE Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm Infants:
- A prospective cohort very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
- Infant is less than or equal to 7 days old when approached about the study.
- Parents:
- -Parents (including emancipated minors age 12-17) of very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
Who cannot join
- Preterm Infants:
- Known or suspected congenital anomaly, congenital infection (e.g., syphilis, HIV, TORCH), or known prenatal brain lesions (e.g., cysts or infarctions)
- Infants that are wards of the state, or become wards of the state after enrolling in the study. Any data collected beginning at the time the state obtains custody onward will not be used in the research study.
- Infants who are in the open ward area/bed spaces of the SLCH NICU (due to the significant variation in sensory exposure among those infants, and also to provide consistency during the hospital's impending transition to strictly private rooms in the very near future).
- Parents:
- -Parents with limited or no understanding of the English Language
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Supporting and Enhancing NICU Sensory Experiences to Optimize Developmental Outcomes in Preterm Infants
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. The parents of infants in the sensory-based intervention group were educated and supported by trained therapists to give different positive sensory experiences to their infants while hospitalized. The traditional care group received normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory processing, and parent mental health were measured at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year (corrected). Differences between the two groups were explored.
Read the detailed description
Approximately 12%, or 500,000 infants, are born preterm each year in the United States alone. Although survival rates of preterm infants have increased with advances in medical care, the risk of developmental delay and disability has remained constant. Very preterm infants (<32 weeks gestation) necessitate care in the neonatal intensive care unit (NICU) for an average of three months after birth, which is a significant period of time coinciding with a critical window of brain development. While medical factors, such as brain injury, can heighten the risk of adverse neurodevelopmental outcome, the NICU environment may also have deleterious effects on early brain structure and function.
The Influence of Early Environment: Maternal deprivation and isolation from positive sensory experiences are prominent features of orphan studies. Consequences of language and human deprivation include emotional disturbances, delayed cognitive and language skills, and abnormalities evident on magnetic resonance imaging (MRI). Although the preterm infant differs from a child who has been institutionalized or deprived of caregiving attention after full term birth, there are similarities, such as the altered temporal lobe structures, and the pattern of developmental impairments. There is growing evidence supporting the importance of parents in the NICU. Low frequency visits between parents and their hospitalized preterm infants have been associated with suboptimal outcomes, like child abuse and abandonment and adverse emotional functioning. NICU's in Sweden have been successful with engaging parents in care from admission to discharge and have reported shorter hospitalizations. There is also a growing body of evidence supporting positive sensory exposures for preterm infants, including maternal voice recordings, massage, skin-to-skin holding, and vestibular and kinesthetic interventions. In addition, my team has made important research findings pointing to the potential need for developmentally-appropriate sensory exposures in the NICU.
Outcomes Associated with Preterm Birth: While advances in medical technologies have improved the rates of survival among preterm infants, the risk of long-term morbidities remains high, with 50-70% of very preterm infants exhibiting developmental problems. In addition to motor problems, language and communication problems are common in former preterm infants when studied at school age, and recent evidence suggests that language deficits persist through childhood. Language difficulties have also been shown to affect a broad range of factors important for social prowess and academic achievement. In addition, preterm infants have a heightened risk of attachment disorders and other social-emotional problems.
Outcomes Associated with Parenting a Preterm Infant: Many negative psychological sequelae are associated with parenting a preterm infant, including depression, anxiety, and post-traumatic stress. Such negative parental mental health outcomes proceed to influence the parent-child relationship, leading to a parent's inability to recognize infant cues as well as increased negativity and intrusiveness. Negative maternal-child interactions continue into the first several months of life if stress remains high. Forming such a foundation may then lead to negative child outcomes associated with social-emotional development, including attachment insecurity, and mental health issues.
Sensory Stimuli and Current Practice in the NICU: High-risk infants who receive care in the NICU are exposed to significant stressors that include painful procedures, disruption of normal sensory experiences, and stress related to parent-infant separation. In addition to the loss of parental nurturing, there is growing concern that stress during a period of extensive brain development may result in permanent and deleterious developmental outcomes.
Developmental care, which includes sensory minimization, has been the predominant model of care in the NICU since the 1980s, because the bright and noisy environment, which exceeds sensory standards set by the American Academy of Pediatrics, is understood to adversely affect growth and development of the preterm infant. In support of developmental care principles, NICU staff makes efforts to reduce modifiable stimuli to the high-risk infant in the NICU. However, there is emerging research on the positive effects of sensory stimulation for preterm infants in the NICU.
Positive sensory exposures in the NICU are critical, as they can have life-long implications on learning, memory, emotions, and developmental progression. In an environment where stimuli are primarily negative, it is especially important to define and implement positive sensory exposures in the NICU. Further, it is well understood that multi-dimensional sensory exposures are present in utero in the final months and weeks of pregnancy, but the preterm infant misses potentially important, timed exposures that may be absent or altered in the NICU environment. Positive forms of sensory exposure during periods of infant readiness may be important to facilitate appropriate neural pathways and enable positive experiences.
Results from a rigorous systematic review, benchmarking, and expert opinion were used to develop a clinical practice guideline for sensory-based interventions for hospitalized, very preterm infants using the Appraisal of Guidelines for Research and Evaluation II instrument. The manualized intervention (from the integrative review and development of the implementation plan) includes evidenced-based interventions that can be conducted by parents with their preterm infants across postmenstrual age while hospitalized. The sensory-based intervention includes the provision of specific amounts of auditory, tactile, vestibular, kinesthetic, olfactory, and visual exposure to be conducted daily through hospitalization. The intervention plan is intended to be implemented by parents (when available) and by surrogates when the parents are unable to be present in the hospital. Surveys, focus groups of a multidisciplinary team of health care professionals and parents of preterm infants in the NICU, and a pilot/feasibility study were conducted to assess acceptability, appropriateness and feasibility of the sensory-based intervention plan. The investigators enrolled 30 very preterm infants within the first week of life and implemented the sensory-based program. Logging sheets were placed at the infant's bedside to document the execution of sensory-based interventions, who conducted the intervention (parent, member of research team or other caregiver), and infant responses and consequences of the intervention. Physiological (such as heart rate and oxygen saturation fluctuations), state (levels of arousal) and behavioral (such as crying, changes in motoric tone) responses were recorded by caregivers during interventions on the bedside logs. Negative sequelae of the intervention resulted in stopping the intervention and modifying the criteria for sensory-based interventions accordingly. A licensed therapist provided guidance as to when infants can and cannot tolerate sensory exposures. From clinical documentation and bedside logging, implementation factors were assessed. Adaptations to the sensory-based program were made until it was deemed appropriate by the investigative team. This occurred after the model for an enhanced sensory environment could be documented 75% of the time on at least 3 consecutive participants.
The aim of this randomized clinical trial was to assess the effect of a sensory-based intervention in the NICU on outcomes of preterm infants and their families.
After obtaining informed consent, 70 preterm infants were randomized to 2 levels of sensory exposure: the sensory-based intervention or traditional care group. The parents of infants in the sensory-based intervention group were educated and supported to conduct sensory interventions with their infants using the systematized protocol. The traditional care group had therapists and nurses provide and educate parents about sensory exposures as standard of care. For both care groups, infant neurobehavior, sensory processing, mother-infant interaction, and parent mental health were assessed at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year corrected using standardized measures. Differences between groups were explored.
- Conditions
- Premature Birth of Newborn
- Being tested
- SENSE Program
- Keywords
- preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE ProgramOther
Also called Sensory-Based Intervention
Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group received standard hospital care. |
| Intervention | Experimental | Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. Receives: Other: SENSE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ages and Stages Questionnaire (ASQ) - Communication at 1 Year
Parents completed the parent-report measure of child development, the Ages and Stages Questionnaire (ASQ), at 1 year corrected age. The ASQ The Communication subscore is the primary variable of interest, which looks at the child's language and communication skills at time of assessment. Higher scores on the ASQ Communication subsection indicate more positive outcomes. A child can score a minimum of 0 points and a maximum of 60 points on the Communication subscale.
Measured: One year corrected age
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age
Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) by a blinded evaluator. The Excitability subscore, which measures state-related level of arousal over the course of the whole examination, is the primary variable of interest, and ranges from 1-8. An average response falls in the moderate, midpoint range (4-5), and describes an infant who could be brought to respond to stimuli in spite of a high degree of upset or excitement, but then can return to moderate state. Thus, a midpoint range score (4-5) would indicate a better outcome on the Excitability sub scale, whereas a lower (<4) or higher (>5) score would indicate a worse outcome.
Measured: At term equivalent age (35-41 weeks PMA)
Secondary outcomes (10)
Language Environmental Acquisition Device (LENA)
Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and quantifies: % of the recording with meaningful word exposure, % of the recording with electronic noise, % of the recording with noise, % of the recording with silence, and % of the recording with distant word exposure.
Measured: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.
Sensory Exposures Provided During Hospitalization
During each day of hospitalization (from day of consent, often within 1 week of birth, to day of discharge, often near term-equivalent age; an average of about 2 months), parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The proportion of the SENSE program doses, whether parents conducted the majority of the sensory exposures and whether the doses were met were defined after hospital discharge was complete.
Measured: Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months).
Dubowitz/Hammersmith Neonatal Neurological Evaluation
At the NICU bedside, infant neurobehavior was assessed by a blinded evaluator using the Dubowitz/Hammersmith Neonatal Neurological Evaluation (HNNE). The HNNE is an assessment of neonatal neurological status. The total score is used as an outcome variable and ranges from 0-78. A higher score indicates a better outcome, whereas a lower score indicates a worse outcome.
Measured: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.
General Movement Assessment (GMA)
A video recording was conducted to enable scoring of general movements and infant neurological/motor status using the General Movements Assessment. However, video quality was deemed insufficient for analysis.
Measured: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.
Discharge Questionnaire
Prior to discharge from the hospital, the infant's mother completed a questionnaire. Measures included the Sensory Profile-2 (SP-2), the State Trait Anxiety Inventory (STAI), the Edinburgh Postnatal Depression Scale (EPDS), the Parent Stress Index (PSI), The Parental Stress Scale: NICU (PSS), the Maternal Confidence Questionnaire, and the Infant Care Questionnaire (ICQ). The SP-2 assesses infant sensory processing skills with summary scores for tactile, auditory, visual, movement, oral, and general processing. The STAI measures maternal anxiety separated into state-related and trait-related anxiety. The PSI includes subscales to measure defensive responding, parental distress, parent-child dysfunctional interaction, \& difficult child behaviors. The ICQ measures maternal connection, emotionality, and responsiveness. Possible score ranges and directions of scores listed with each variable below.
Measured: Just prior to discharge from the hospital (between 35-41 weeks post menstrual age).
1 Year Follow-Up Questionnaire
The infant's mother completed a questionnaire with the following measures: the ASQ, SP-2, STAI, Beck Depression Inventory (BDI), PSI, Maternal Confidence Questionnaire (MCQ), ICQ, Pediatric Eating Assessment Tool (Pedi-eat), and Behavioral Pediatrics Feeding Assessment Scale (BPFAS). ASQ, SP-2, STAI, PSI, MCQ, and ICQ are previously described in discharge questionnaire outcome data. The BDI was used to measure maternal depression at time of follow-up. The Pedi-eat and BPFAS were used to assess infant feeding skills. Possible score ranges and directions of scores are reported below under each individual variable.
Measured: One year corrected age.
Mother-Infant Interaction (at 1 Year Follow-up)
At one year follow-up, mother-infant interaction will be assessed through the interaction subscale of the Parental Stress Index (PSI). A score in this subscale can range from 12-60, with higher scores indicating a greater degree of dysfunction.
Measured: One year corrected age.
Parent Engagement During Hospitalization
On each day of hospitalization (from birth to discharge, which often occurred close to term equivalent age; for an average of about 2 months), parents, health care professionals and the sensory support team documented the frequency of parent visitation, holding, and skin-to-skin care.
Measured: Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months).
Language Environmental Acquisition Device (LENA) Adult Word Count
Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and can quantify the number of adult words spoken during the 16 hour recording.
Measured: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.
Percentage of Sensory Interventions Received
Throughout hospitalization, parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The percentage of recommended sensory doses that were received were documented.
Measured: Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start16 Aug 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (89)Papers the sponsor has linked to this study.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SENSE program-treatment; standard-of-care-control
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
- Investigators
- Roberta G Pineda, PhD, OTR/L, Principal investigator, Washington University School of Medicine; University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316547
- Sponsor's protocol ID
- 201601057
- Acronym
- SENSE
- Status last verified
- Jun 2021
- First submitted
- 15 Aug 2017
- Last updated
- 7 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Volpe, J., Neurology of the Newborn 2008, Saunders: Philadelphia.
Seay B, Harlow HF. Maternal separation in the rhesus monkey. J Nerv Ment Dis. 1965 Jun;140(6):434-41. doi: 10.1097/00005053-196506000-00006. No abstract available.
PubMed 4953280Tottenham N, Hare TA, Quinn BT, McCarry TW, Nurse M, Gilhooly T, Millner A, Galvan A, Davidson MC, Eigsti IM, Thomas KM, Freed PJ, Booma ES, Gunnar MR, Altemus M, Aronson J, Casey BJ. Prolonged institutional rearing is associated with atypically large amygdala volume and difficulties in emotion regulation. Dev Sci. 2010 Jan 1;13(1):46-61. doi: 10.1111/j.1467-7687.2009.00852.x.
PubMed 20121862Tottenham N, Sheridan MA. A review of adversity, the amygdala and the hippocampus: a consideration of developmental timing. Front Hum Neurosci. 2010 Jan 8;3:68. doi: 10.3389/neuro.09.068.2009. eCollection 2009.
PubMed 20161700BRODBECK AJ, IRWIN OC. The speech behaviour of infants without families. Child Dev. 1946 Sep;17(3):145-56. No abstract available.
PubMed 20285787Govindan RM, Behen ME, Helder E, Makki MI, Chugani HT. Altered water diffusivity in cortical association tracts in children with early deprivation identified with Tract-Based Spatial Statistics (TBSS). Cereb Cortex. 2010 Mar;20(3):561-9. doi: 10.1093/cercor/bhp122. Epub 2009 Jun 22.
PubMed 19546156Aeby A, Van Bogaert P, David P, Baleriaux D, Vermeylen D, Metens T, De Tiege X. Nonlinear microstructural changes in the right superior temporal sulcus and lateral occipitotemporal gyrus between 35 and 43 weeks in the preterm brain. Neuroimage. 2012 Oct 15;63(1):104-10. doi: 10.1016/j.neuroimage.2012.06.013. Epub 2012 Jun 17.
PubMed 22713672Barre N, Morgan A, Doyle LW, Anderson PJ. Language abilities in children who were very preterm and/or very low birth weight: a meta-analysis. J Pediatr. 2011 May;158(5):766-774.e1. doi: 10.1016/j.jpeds.2010.10.032. Epub 2010 Dec 10.
PubMed 21146182Reynolds LC, Duncan MM, Smith GC, Mathur A, Neil J, Inder T, Pineda RG. Parental presence and holding in the neonatal intensive care unit and associations with early neurobehavior. J Perinatol. 2013 Aug;33(8):636-41. doi: 10.1038/jp.2013.4. Epub 2013 Feb 14.
PubMed 23412640Fanaroff AA, Kennell JH, Klaus MH. Follow-up of low birth weight infants--the predictive value of maternal visiting patterns. Pediatrics. 1972 Feb;49(2):287-90. No abstract available.
PubMed 5059535Latva R, Lehtonen L, Salmelin RK, Tamminen T. Visiting less than every day: a marker for later behavioral problems in Finnish preterm infants. Arch Pediatr Adolesc Med. 2004 Dec;158(12):1153-7. doi: 10.1001/archpedi.158.12.1153.
PubMed 15583100Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.
PubMed 20100748Krueger C, Parker L, Chiu SH, Theriaque D. Maternal voice and short-term outcomes in preterm infants. Dev Psychobiol. 2010 Mar;52(2):205-12. doi: 10.1002/dev.20426.
PubMed 20112262Diego MA, Field T, Hernandez-Reif M. Preterm infant weight gain is increased by massage therapy and exercise via different underlying mechanisms. Early Hum Dev. 2014 Mar;90(3):137-40. doi: 10.1016/j.earlhumdev.2014.01.009. Epub 2014 Jan 27.
PubMed 24480603Hernandez-Reif M, Diego M, Field T. Preterm infants show reduced stress behaviors and activity after 5 days of massage therapy. Infant Behav Dev. 2007 Dec;30(4):557-61. doi: 10.1016/j.infbeh.2007.04.002. Epub 2007 Jun 4.
PubMed 17548111
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting and Enhancing NICU Sensory Experiences to Optimize Developmental Outcomes in Preterm Infants
- ClinicalTrials.gov ID
- NCT03316547
- Acronym / sponsor ID
- SENSE / 201601057
- Conditions
- Premature Birth of Newborn
- Keywords
- preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. The parents of infants in the sensory-based intervention group were educated and supported by trained therapists to give different positive sensory experiences to their infants while hospitalized. The traditional care group received normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory processing, and parent mental health were measured at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year (corrected). Differences between the two groups were explored.
Detailed description
Approximately 12%, or 500,000 infants, are born preterm each year in the United States alone. Although survival rates of preterm infants have increased with advances in medical care, the risk of developmental delay and disability has remained constant. Very preterm infants (<32 weeks gestation) necessitate care in the neonatal intensive care unit (NICU) for an average of three months after birth, which is a significant period of time coinciding with a critical window of brain development. While medical factors, such as brain injury, can heighten the risk of adverse neurodevelopmental outcome, the NICU environment may also have deleterious effects on early brain structure and function.
The Influence of Early Environment: Maternal deprivation and isolation from positive sensory experiences are prominent features of orphan studies. Consequences of language and human deprivation include emotional disturbances, delayed cognitive and language skills, and abnormalities evident on magnetic resonance imaging (MRI). Although the preterm infant differs from a child who has been institutionalized or deprived of caregiving attention after full term birth, there are similarities, such as the altered temporal lobe structures, and the pattern of developmental impairments. There is growing evidence supporting the importance of parents in the NICU. Low frequency visits between parents and their hospitalized preterm infants have been associated with suboptimal outcomes, like child abuse and abandonment and adverse emotional functioning. NICU's in Sweden have been successful with engaging parents in care from admission to discharge and have reported shorter hospitalizations. There is also a growing body of evidence supporting positive sensory exposures for preterm infants, including maternal voice recordings, massage, skin-to-skin holding, and vestibular and kinesthetic interventions. In addition, my team has made important research findings pointing to the potential need for developmentally-appropriate sensory exposures in the NICU.
Outcomes Associated with Preterm Birth: While advances in medical technologies have improved the rates of survival among preterm infants, the risk of long-term morbidities remains high, with 50-70% of very preterm infants exhibiting developmental problems. In addition to motor problems, language and communication problems are common in former preterm infants when studied at school age, and recent evidence suggests that language deficits persist through childhood. Language difficulties have also been shown to affect a broad range of factors important for social prowess and academic achievement. In addition, preterm infants have a heightened risk of attachment disorders and other social-emotional problems.
Outcomes Associated with Parenting a Preterm Infant: Many negative psychological sequelae are associated with parenting a preterm infant, including depression, anxiety, and post-traumatic stress. Such negative parental mental health outcomes proceed to influence the parent-child relationship, leading to a parent's inability to recognize infant cues as well as increased negativity and intrusiveness. Negative maternal-child interactions continue into the first several months of life if stress remains high. Forming such a foundation may then lead to negative child outcomes associated with social-emotional development, including attachment insecurity, and mental health issues.
Sensory Stimuli and Current Practice in the NICU: High-risk infants who receive care in the NICU are exposed to significant stressors that include painful procedures, disruption of normal sensory experiences, and stress related to parent-infant separation. In addition to the loss of parental nurturing, there is growing concern that stress during a period of extensive brain development may result in permanent and deleterious developmental outcomes.
Developmental care, which includes sensory minimization, has been the predominant model of care in the NICU since the 1980s, because the bright and noisy environment, which exceeds sensory standards set by the American Academy of Pediatrics, is understood to adversely affect growth and development of the preterm infant. In support of developmental care principles, NICU staff makes efforts to reduce modifiable stimuli to the high-risk infant in the NICU. However, there is emerging research on the positive effects of sensory stimulation for preterm infants in the NICU.
Positive sensory exposures in the NICU are critical, as they can have life-long implications on learning, memory, emotions, and developmental progression. In an environment where stimuli are primarily negative, it is especially important to define and implement positive sensory exposures in the NICU. Further, it is well understood that multi-dimensional sensory exposures are present in utero in the final months and weeks of pregnancy, but the preterm infant misses potentially important, timed exposures that may be absent or altered in the NICU environment. Positive forms of sensory exposure during periods of infant readiness may be important to facilitate appropriate neural pathways and enable positive experiences.
Results from a rigorous systematic review, benchmarking, and expert opinion were used to develop a clinical practice guideline for sensory-based interventions for hospitalized, very preterm infants using the Appraisal of Guidelines for Research and Evaluation II instrument. The manualized intervention (from the integrative review and development of the implementation plan) includes evidenced-based interventions that can be conducted by parents with their preterm infants across postmenstrual age while hospitalized. The sensory-based intervention includes the provision of specific amounts of auditory, tactile, vestibular, kinesthetic, olfactory, and visual exposure to be conducted daily through hospitalization. The intervention plan is intended to be implemented by parents (when available) and by surrogates when the parents are unable to be present in the hospital. Surveys, focus groups of a multidisciplinary team of health care professionals and parents of preterm infants in the NICU, and a pilot/feasibility study were conducted to assess acceptability, appropriateness and feasibility of the sensory-based intervention plan. The investigators enrolled 30 very preterm infants within the first week of life and implemented the sensory-based program. Logging sheets were placed at the infant's bedside to document the execution of sensory-based interventions, who conducted the intervention (parent, member of research team or other caregiver), and infant responses and consequences of the intervention. Physiological (such as heart rate and oxygen saturation fluctuations), state (levels of arousal) and behavioral (such as crying, changes in motoric tone) responses were recorded by caregivers during interventions on the bedside logs. Negative sequelae of the intervention resulted in stopping the intervention and modifying the criteria for sensory-based interventions accordingly. A licensed therapist provided guidance as to when infants can and cannot tolerate sensory exposures. From clinical documentation and bedside logging, implementation factors were assessed. Adaptations to the sensory-based program were made until it was deemed appropriate by the investigative team. This occurred after the model for an enhanced sensory environment could be documented 75% of the time on at least 3 consecutive participants.
The aim of this randomized clinical trial was to assess the effect of a sensory-based intervention in the NICU on outcomes of preterm infants and their families.
After obtaining informed consent, 70 preterm infants were randomized to 2 levels of sensory exposure: the sensory-based intervention or traditional care group. The parents of infants in the sensory-based intervention group were educated and supported to conduct sensory interventions with their infants using the systematized protocol. The traditional care group had therapists and nurses provide and educate parents about sensory exposures as standard of care. For both care groups, infant neurobehavior, sensory processing, mother-infant interaction, and parent mental health were assessed at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year corrected using standardized measures. Differences between groups were explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- SENSE program-treatment; standard-of-care-control
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group received standard hospital care. |
| Intervention | Experimental | Other: SENSE ProgramParents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A prospective cohort very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
- Infant is less than or equal to 7 days old when approached about the study.
- -Parents (including emancipated minors age 12-17) of very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
Key exclusion criteria (6 listed)
- Known or suspected congenital anomaly, congenital infection (e.g., syphilis, HIV, TORCH), or known prenatal brain lesions (e.g., cysts or infarctions)
- Infants that are wards of the state, or become wards of the state after enrolling in the study. Any data collected beginning at the time the state obtains custody onward will not be used in the research study.
- Infants who are in the open ward area/bed spaces of the SLCH NICU (due to the significant variation in sensory exposure among those infants, and also to provide consistency during the hospital's impending transition to strictly private rooms in the very near future).
- -Parents with limited or no understanding of the English Language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENSE ProgramAlso: Sensory-Based InterventionSpecific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. | Other | Intervention |
Primary outcome
Ages and Stages Questionnaire (ASQ) - Communication at 1 Year
Time frame: One year corrected age
Parents completed the parent-report measure of child development, the Ages and Stages Questionnaire (ASQ), at 1 year corrected age. The ASQ The Communication subscore is the primary variable of interest, which looks at the child's language and communication skills at time of assessment. Higher scores on the ASQ Communication subsection indicate more positive outcomes. A child can score a minimum of 0 points and a maximum of 60 points on the Communication subscale.
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age
Time frame: At term equivalent age (35-41 weeks PMA)
Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) by a blinded evaluator. The Excitability subscore, which measures state-related level of arousal over the course of the whole examination, is the primary variable of interest, and ranges from 1-8. An average response falls in the moderate, midpoint range (4-5), and describes an infant who could be brought to respond to stimuli in spite of a high degree of upset or excitement, but then can return to moderate state. Thus, a midpoint range score (4-5) would indicate a better outcome on the Excitability sub scale, whereas a lower (<4) or higher (>5) score would indicate a worse outcome.
10 secondary outcomes
Language Environmental Acquisition Device (LENA)
Time frame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.
Sensory Exposures Provided During Hospitalization
Time frame: Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months).
Dubowitz/Hammersmith Neonatal Neurological Evaluation
Time frame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.
General Movement Assessment (GMA)
Time frame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.
Discharge Questionnaire
Time frame: Just prior to discharge from the hospital (between 35-41 weeks post menstrual age).
1 Year Follow-Up Questionnaire
Time frame: One year corrected age.
Mother-Infant Interaction (at 1 Year Follow-up)
Time frame: One year corrected age.
Parent Engagement During Hospitalization
Time frame: Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months).
Language Environmental Acquisition Device (LENA) Adult Word Count
Time frame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.
Percentage of Sensory Interventions Received
Time frame: Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundVolpe, J., Neurology of the Newborn 2008, Saunders: Philadelphia.
- Background: PubMed 4953280Seay B, Harlow HF. Maternal separation in the rhesus monkey. J Nerv Ment Dis. 1965 Jun;140(6):434-41. doi: 10.1097/00005053-196506000-00006. No abstract available.
- Background: PubMed 20121862Tottenham N, Hare TA, Quinn BT, McCarry TW, Nurse M, Gilhooly T, Millner A, Galvan A, Davidson MC, Eigsti IM, Thomas KM, Freed PJ, Booma ES, Gunnar MR, Altemus M, Aronson J, Casey BJ. Prolonged institutional rearing is associated with atypically large amygdala volume and difficulties in emotion regulation. Dev Sci. 2010 Jan 1;13(1):46-61. doi: 10.1111/j.1467-7687.2009.00852.x.
- Background: PubMed 20161700Tottenham N, Sheridan MA. A review of adversity, the amygdala and the hippocampus: a consideration of developmental timing. Front Hum Neurosci. 2010 Jan 8;3:68. doi: 10.3389/neuro.09.068.2009. eCollection 2009.
- Background: PubMed 20285787BRODBECK AJ, IRWIN OC. The speech behaviour of infants without families. Child Dev. 1946 Sep;17(3):145-56. No abstract available.
- Background: PubMed 19546156Govindan RM, Behen ME, Helder E, Makki MI, Chugani HT. Altered water diffusivity in cortical association tracts in children with early deprivation identified with Tract-Based Spatial Statistics (TBSS). Cereb Cortex. 2010 Mar;20(3):561-9. doi: 10.1093/cercor/bhp122. Epub 2009 Jun 22.
- Background: PubMed 22713672Aeby A, Van Bogaert P, David P, Baleriaux D, Vermeylen D, Metens T, De Tiege X. Nonlinear microstructural changes in the right superior temporal sulcus and lateral occipitotemporal gyrus between 35 and 43 weeks in the preterm brain. Neuroimage. 2012 Oct 15;63(1):104-10. doi: 10.1016/j.neuroimage.2012.06.013. Epub 2012 Jun 17.
- Background: PubMed 21146182Barre N, Morgan A, Doyle LW, Anderson PJ. Language abilities in children who were very preterm and/or very low birth weight: a meta-analysis. J Pediatr. 2011 May;158(5):766-774.e1. doi: 10.1016/j.jpeds.2010.10.032. Epub 2010 Dec 10.
- Background: PubMed 23412640Reynolds LC, Duncan MM, Smith GC, Mathur A, Neil J, Inder T, Pineda RG. Parental presence and holding in the neonatal intensive care unit and associations with early neurobehavior. J Perinatol. 2013 Aug;33(8):636-41. doi: 10.1038/jp.2013.4. Epub 2013 Feb 14.
- Background: PubMed 5059535Fanaroff AA, Kennell JH, Klaus MH. Follow-up of low birth weight infants--the predictive value of maternal visiting patterns. Pediatrics. 1972 Feb;49(2):287-90. No abstract available.
- Background: PubMed 15583100Latva R, Lehtonen L, Salmelin RK, Tamminen T. Visiting less than every day: a marker for later behavioral problems in Finnish preterm infants. Arch Pediatr Adolesc Med. 2004 Dec;158(12):1153-7. doi: 10.1001/archpedi.158.12.1153.
- Background: PubMed 20100748Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta G Pineda, PhD, OTR/L principal investigator
Washington University School of Medicine; University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSE Program in people with Premature Birth of Newborn, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ages and Stages Questionnaire (ASQ) - Communication at 1 Year (time frame: One year corrected age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03316547, which also lists 89 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.