Premature BirthNCT02352142
Family Nurture Intervention in the CHoNJ NICU
A study testing Full Term EEG and Facilitated Infant Care in people with Premature Birth, run by Columbia University at 2 sites in United States.
Trial summary
The purpose of this proposal is to conduct a replication study of Family Nurture Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early development. Read more about this study
- Who is it for?
- Ages 26 to 42 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Full Term EEG and Facilitated Infant Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 26 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant is between 26/0 and 32/6 weeks gestational age upon admission for the INTERVENTION / STANDARD care group OR 38-42 weeks for the FULL TERM group
- Infant's weight is appropriate for gestational age (AGA)
- Infant is a singleton
- Mother is 18 years of age or older
- Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent) (not applicable for FULL TERM group)
Who cannot join
- Infant's attending does not recommend enrollment in study
- The infant has severe congenital anomalies, including chromosomal anomalies or an Intraventricular Hemorrhage (IVH) Grades 3 and 4
- Mother has known history of substance abuse, severe psychiatric illness or psychosis
- Status of enrolled subject changes and subject no longer falls in inclusion criteria
- Mother and/or infant has a medical condition that precludes intervention components
- Mother and/or infant has a contagion that endangers other participants in the study
- Mother-Infant dyad receives less than one week of intervention (not applicable to the FULL TERM group)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Data Coordinating Center
New York, New York, 10032
Children's Hospital of New Jersey
Newark, New Jersey, 07112
About this study
Official title: Randomized Control Trial of Family Nurture Intervention in the Children's Hospital of New Jersey Neonatal Intensive Care Unit
The purpose of this proposal is to conduct a replication study of Family Nurture Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early development. These include early and repeated mother/infant calming interactions during the NICU stay, such as interactive touch with vocal soothing, sustained reciprocal olfactory exposure and family practice in comforting, and systematically implemented skin to skin holding. This has already been studied at CHONY. Findings reveal that infants who receive FNI have significant increases in EEG power, a measure of brain activity, near to term age, when compared with those who receive Standard Care.
There will be two groups; STANDARD CARE (SC) and INTERVENTION (FNI). In addition, 10 pilot subjects will be enrolled to train the staff involved in the procedures used in this Randomized Control Trial (RCT). The pilot patients will be enrolled identical to study patients and will be encouraged to participate fully. They will not be included in the analysis of the RCT.
Read more
The STANDARD CARE group will receive current standard of care in NICU. The INTERVENTION group, in addition to the standard care, will receive the FNI intervention, which will be facilitated by our Nurture Specialists. In addition to the SC and FNI groups, there will be a third non-randomized group of infants born at term age who will receive standard care for newborns at CHoNJ. Assessments in the NICU will include physiological measures (ECG EEG), measures of maternal sensitivity through recorded mother-infant interactions and a variety of specimen collections (saliva, blood, and breast milk samples). The investigators will be conducting two follow up studies, at 4 months corrected age and at 12 months corrected age. The investigators will test the immediate and long-term effects of this approach to the development of preterm infants.
The investigators hypothesize that this intervention will alter a wide range of indices of physiological regulatory capacities, and increase brain activity as measured by EEG (power and coherence) such that a brain activation pattern in the intervention group will be more similar to that of full term infants as opposed to the standard care group. Longer term indices of mother psychological and infant neurobehavioral outcomes will also be improved when assessed during the first few months of life.
Read the detailed description
The purpose of this study is to compare the value of the current approach of encouraging contact between mothers and their babies (Standard Care) in the NICU with a more wide ranging enhanced approach (Family Nurture Intervention). This approach is based on enhancing aspects of maternal nurturing including mother-infant reciprocal calming, which are vital to early development. A specific goal is to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her caretaking abilities. Since preterm babies are often easily upset, this study will facilitate mothers in comforting and calming their babies. An earlier study at Morgan Stanley Children's Hospital of New York (CHONY) has shown positive outcomes in the enhanced treatment group in a variety of areas, including EEG brain activity at term age. Assessments in the NICU and in secondary follow-up measures at 4, and 12 months of age will test the immediate and long-term effects of this new enhanced approach to the nurture of prematurely born infants. We will undertake a replication study on patients in the NICU at CHoNJ to confirm and further elucidate the positive effects of enhanced nurturing.
We hypothesize that enhanced nurturing will alter a wide range of physiologic regulatory capacities, reduce morbidity, decrease Length of Stay (LOS) and increase brain activity as measured by EEG (power and coherence). In addition this approach may influence a brain activation pattern (particularly in the area of the anterior cerebral cortex responsible for executive decision-making) in the intervention group that is more similar to that of a full term infant. Longer term measures of mother's psychological and infant's neurobehavioral outcomes will also be improved when assessed during the first few months of life.
This study aims to replicate and build on an existing study at Morgan Stanley Children's Hospital of New York (CHONY) that compares the current protocol for encouraging mother/infant interactions (standard care) with a multifaceted intervention to enhance mother and infant bonding (Family Nurture Intervention - FNI). The FNI was piloted and studied in a cohort of 150 mother-infant pairs at CHONY beginning in 2009. While the study is ongoing, significant differences in brain activity of these preterm infants was found at term as measured by EEG power in the intervention premature infants as compared to the standard care group, with no increased risk of morbidity or mortality in the intervention group. The study demonstrated that the approach may influence a brain activation pattern (particularly in the area of the anterior cerebral cortex responsible for executive decision-making) in the intervention group that is more similar to that of a full term infant (38-42 weeks gestation).
This and other research warrants the investigation of better intervention strategies that can reduce morbidity and ameliorate adverse outcomes in these infants.
The purpose of this current study is to determine whether the findings from CHONY are replicable, the efficacy of the FNI protocol in improving developmental outcomes in preterm births in a different cohort (at CHoNJ) and to compare the outcomes of patients in two different hospital environments.
The study will again compare the current standard of care in the NICU, which includes periodic skin-to-skin holding, to a Family Nurture Intervention (FNI) which adds other interventions: interactive touch with vocal soothing, sustained reciprocal olfactory exposure, and family modeling and practice in comforting as well as a more systematic implementation of skin-to-skin holding. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better prevention of developmental disorders, reduced morbidity and more effective clinical intervention strategies both in the neonatal intensive care unit (NICU) and after discharge. We hypothesize that the treated babies will show better results in the primary outcome measure in the short term and secondary long term as compared to infants undergoing standard care.
- Conditions
- Premature Birth
- Being tested
- Full Term EEG, Facilitated Infant Care
- Keywords
- Separation stress, Family Nurture, Maternal Confidence, Maternal Competence, Calming Cycle, Kangaroo Care, Infant Neurodevelopment, Infant Psychological Development, Post-partum depression, Mother-infant Co-regulation
- Medical subject headings
- Premature Birth, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Term EEGOther
Full-term infants assigned to this arm of the study will receive one sleep EEG (one hour in duration). These EEGs will be used as healthy control comparisons to those of premature infants at 40 weeks.
Facilitated Infant CareBehavioural
Also called Family Nurture Intervention
Family Nurture Intervention is facilitated by specially trained Nurture Specialists. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Mothers are given infant care instruction as part of standard care |
| Facilitated infant care | Experimental | Family Nurture Intervention Receives: Behavioral: Facilitated Infant Care |
| Full Term EEG | Other | Small group of healthy, Full-Term infants will receive two sleep EEGs (one in unit, and one 4 weeks post discharge) for healthy control comparison to preterm infants Receives: Other: Full Term EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG measures of power and coherence
Two one-hour sleep EEGs will take place. One at 34-36 weeks Gestational Age, and one at term age
Measured: 34 weeks gestational age through term age
Secondary outcomes (9)
Maternal measures of anxiety, depression and care-giving
Measures of maternal depression and anxiety and maternal care-giving will be compared between standard care and intervention groups using analyses of variance. The measures will also be compared within groups, using repeated measures ANOVA.
Measured: Up to 12 months of age
Measure of mother time spent with infant in unit and in skin to skin
Measures of parental visiting hours and occurrence of skin to skin will be compared within groups. We will use parent and nurture specialist report to measure parental visiting hours and occurrence of skin to skin.
Measured: Duration of infant stay in unit (roughly 35 days)
Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III
At 4 and 12 months corrected age, infants are administered the Bayley Scales of Infant and Toddler Development, Bayley III consisting of four subscales: Cognitive, Language (receptive/expressive), Motor (fine/gross) and Social-Emotional. These filmed assessments, made by research staff 'blind' to infant group assignment, provide information about the neurobehavioral status of the child and whether there are significant delays in key domains of motor, language, and cognitive development.
Measured: Up to 12 month corrected age
Physiological Assessments- salivary cortisol
As a component of the mother-infant interaction assessments conducted at 4 and 12 months corrected age, salivary cortisol levels are measured at four times during each session. These measures provide physiological indices of how the infants respond to a social interaction stressor.
Measured: Up to 24 months corrected age
Physiological Assessments- breast milk
Breast milk collections will be analyzed in order to measure levels of pro-inflammatory cytokines, oxytocin and other peptides.
Measured: The duration of the infant stay in unit, or an average of 5 weeks
Physiological Assessments- infant stool collection
Infant stool collections will be made in order to measure levels of inflammation-related cytokines and other peptides.
Measured: The duration of the infant stay in unit, or an average of 5 weeks
Physiological Assessments- infant blood samples
Infant blood samples will be collected by piggy-backing off of standard care heel-sticks by hospital staff. These samples will be analyzed for presence of oxytocin and other applicable peptides
Measured: The duration of the infant stay in unit, or an average of 5 weeks
Mother-Infant Interactions Assessments: Evaluating the qualities of the mother's interaction with her infant during diaper change
Videos of infant's diaper change are obtained and coded by research team members unfamiliar with the dyads' group assignment at 4 months corrected age. The mother is instructed to undress her infant, remove the diaper, wipe clean, and re-dress her infant. These familiar caregiving procedures represent a mild, ecologically valid stressor. Maternal behavior is coded, using a 9-point Likert scale for: (a) Acceptance vs. Rejection; (b) Soothing capability; (c) Consideration vs. Intrusiveness; (d) Quality of Physical Contact; and (e) Quality of Vocal Contact.
Measured: Up to 4 months corrected age
Mother-Infant Interaction Assessments: Mother-infant face-to-face communicative competence, sensitivity of maternal caregiving and mother and infant physiological capacity to cope with a stressor
A split-screen filming session is conducted following protocols and analyzed by team members 'blind' to the dyads' group assignments at 4, 12, and 24 months corrected age. The videotapes consist of: (1) mother-infant play; (2) stranger-infant play (3) diaper change; (4) the Still Face protocol in which mothers assume an expressionless face for two minutes. Primary measures are: infant gaze aversion, mother-infant gaze coordination, infant distress, maternal interaction style (affectionate vs. intrusive), and responses of mothers and infants to gaze aversion. Additionally, research staff blind to group assignment will assess the quality of the mother-infant interaction with the Biphasic Emotional Connection Scale.
Measured: Up to 12 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: insufficient enrollment numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Newark Beth Israel Medical Center
- Responsible party
- Principal investigator, Martha G. Welch, MD, Columbia University
- Investigators
- Martha G Welch, MD, Principal investigator, Columbia University Medical Center, Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352142
- Sponsor's protocol ID
- AAAN6850
- Status last verified
- Jul 2016
- First submitted
- 16 Jan 2015
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ravn IH, Smith L, Lindemann R, Smeby NA, Kyno NM, Bunch EH, Sandvik L. Effect of early intervention on social interaction between mothers and preterm infants at 12 months of age: a randomized controlled trial. Infant Behav Dev. 2011 Apr;34(2):215-25. doi: 10.1016/j.infbeh.2010.11.004. Epub 2011 Mar 2.
PubMed 21371754Muller-Nix C, Forcada-Guex M, Pierrehumbert B, Jaunin L, Borghini A, Ansermet F. Prematurity, maternal stress and mother-child interactions. Early Hum Dev. 2004 Sep;79(2):145-58. doi: 10.1016/j.earlhumdev.2004.05.002.
PubMed 15324994Meijssen D, Wolf MJ, van Bakel H, Koldewijn K, Kok J, van Baar A. Maternal attachment representations after very preterm birth and the effect of early intervention. Infant Behav Dev. 2011 Feb;34(1):72-80. doi: 10.1016/j.infbeh.2010.09.009. Epub 2010 Nov 9.
PubMed 21067812Meijssen D, Wolf MJ, Koldewijn K, Houtzager BA, van Wassenaer A, Tronick E, Kok J, van Baar A. The effect of the Infant Behavioral Assessment and Intervention Program on mother-infant interaction after very preterm birth. J Child Psychol Psychiatry. 2010 Nov;51(11):1287-95. doi: 10.1111/j.1469-7610.2010.02237.x.
PubMed 20345840Shah PE, Clements M, Poehlmann J. Maternal resolution of grief after preterm birth: implications for infant attachment security. Pediatrics. 2011 Feb;127(2):284-92. doi: 10.1542/peds.2010-1080. Epub 2011 Jan 17.
PubMed 21242223Coppola G, Cassibba R, Costantini A. What can make the difference? Premature birth and maternal sensitivity at 3 months of age: the role of attachment organization, traumatic reaction and baby's medical risk. Infant Behav Dev. 2007 Dec;30(4):679-84. doi: 10.1016/j.infbeh.2007.03.004. Epub 2007 Apr 20.
PubMed 17449102DeBoer RW, Karemaker JM, Strackee J. Comparing spectra of a series of point events particularly for heart rate variability data. IEEE Trans Biomed Eng. 1984 Apr;31(4):384-7. doi: 10.1109/TBME.1984.325351. No abstract available.
PubMed 6745974Hofer MA. Early social relationships: a psychobiologist's view. Child Dev. 1987 Jun;58(3):633-47.
PubMed 3608643Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG. Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects. JAMA. 1994 Sep 21;272(11):853-8.
PubMed 8078162
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Family Nurture Intervention in the Children's Hospital of New Jersey Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02352142
- Acronym / sponsor ID
- AAAN6850
- Conditions
- Premature Birth
- Keywords
- Separation stress, Family Nurture, Maternal Confidence, Maternal Competence, Calming Cycle, Kangaroo Care, Infant Neurodevelopment, Infant Psychological Development
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment numbers
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Newark Beth Israel Medical Center
- Study start
- Jan 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this proposal is to conduct a replication study of Family Nurture Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early development. These include early and repeated mother/infant calming interactions during the NICU stay, such as interactive touch with vocal soothing, sustained reciprocal olfactory exposure and family practice in comforting, and systematically implemented skin to skin holding. This has already been studied at CHONY. Findings reveal that infants who receive FNI have significant increases in EEG power, a measure of brain activity, near to term age, when compared with those who receive Standard Care.
There will be two groups; STANDARD CARE (SC) and INTERVENTION (FNI). In addition, 10 pilot subjects will be enrolled to train the staff involved in the procedures used in this Randomized Control Trial (RCT). The pilot patients will be enrolled identical to study patients and will be encouraged to participate fully. They will not be included in the analysis of the RCT.
The STANDARD CARE group will receive current standard of care in NICU. The INTERVENTION group, in addition to the standard care, will receive the FNI intervention, which will be facilitated by our Nurture Specialists. In addition to the SC and FNI groups, there will be a third non-randomized group of infants born at term age who will receive standard care for newborns at CHoNJ. Assessments in the NICU will include physiological measures (ECG EEG), measures of maternal sensitivity through recorded mother-infant interactions and a variety of specimen collections (saliva, blood, and breast milk samples). The investigators will be conducting two follow up studies, at 4 months corrected age and at 12 months corrected age. The investigators will test the immediate and long-term effects of this approach to the development of preterm infants.
The investigators hypothesize that this intervention will alter a wide range of indices of physiological regulatory capacities, and increase brain activity as measured by EEG (power and coherence) such that a brain activation pattern in the intervention group will be more similar to that of full term infants as opposed to the standard care group. Longer term indices of mother psychological and infant neurobehavioral outcomes will also be improved when assessed during the first few months of life.
Detailed description
The purpose of this study is to compare the value of the current approach of encouraging contact between mothers and their babies (Standard Care) in the NICU with a more wide ranging enhanced approach (Family Nurture Intervention). This approach is based on enhancing aspects of maternal nurturing including mother-infant reciprocal calming, which are vital to early development. A specific goal is to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her caretaking abilities. Since preterm babies are often easily upset, this study will facilitate mothers in comforting and calming their babies. An earlier study at Morgan Stanley Children's Hospital of New York (CHONY) has shown positive outcomes in the enhanced treatment group in a variety of areas, including EEG brain activity at term age. Assessments in the NICU and in secondary follow-up measures at 4, and 12 months of age will test the immediate and long-term effects of this new enhanced approach to the nurture of prematurely born infants. We will undertake a replication study on patients in the NICU at CHoNJ to confirm and further elucidate the positive effects of enhanced nurturing.
We hypothesize that enhanced nurturing will alter a wide range of physiologic regulatory capacities, reduce morbidity, decrease Length of Stay (LOS) and increase brain activity as measured by EEG (power and coherence). In addition this approach may influence a brain activation pattern (particularly in the area of the anterior cerebral cortex responsible for executive decision-making) in the intervention group that is more similar to that of a full term infant. Longer term measures of mother's psychological and infant's neurobehavioral outcomes will also be improved when assessed during the first few months of life.
This study aims to replicate and build on an existing study at Morgan Stanley Children's Hospital of New York (CHONY) that compares the current protocol for encouraging mother/infant interactions (standard care) with a multifaceted intervention to enhance mother and infant bonding (Family Nurture Intervention - FNI). The FNI was piloted and studied in a cohort of 150 mother-infant pairs at CHONY beginning in 2009. While the study is ongoing, significant differences in brain activity of these preterm infants was found at term as measured by EEG power in the intervention premature infants as compared to the standard care group, with no increased risk of morbidity or mortality in the intervention group. The study demonstrated that the approach may influence a brain activation pattern (particularly in the area of the anterior cerebral cortex responsible for executive decision-making) in the intervention group that is more similar to that of a full term infant (38-42 weeks gestation).
This and other research warrants the investigation of better intervention strategies that can reduce morbidity and ameliorate adverse outcomes in these infants.
The purpose of this current study is to determine whether the findings from CHONY are replicable, the efficacy of the FNI protocol in improving developmental outcomes in preterm births in a different cohort (at CHoNJ) and to compare the outcomes of patients in two different hospital environments.
The study will again compare the current standard of care in the NICU, which includes periodic skin-to-skin holding, to a Family Nurture Intervention (FNI) which adds other interventions: interactive touch with vocal soothing, sustained reciprocal olfactory exposure, and family modeling and practice in comforting as well as a more systematic implementation of skin-to-skin holding. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better prevention of developmental disorders, reduced morbidity and more effective clinical intervention strategies both in the neonatal intensive care unit (NICU) and after discharge. We hypothesize that the treated babies will show better results in the primary outcome measure in the short term and secondary long term as compared to infants undergoing standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Mothers are given infant care instruction as part of standard care |
| Facilitated infant care | Experimental | Behavioral: Facilitated Infant CareFamily Nurture Intervention |
| Full Term EEG | Other | Other: Full Term EEGSmall group of healthy, Full-Term infants will receive two sleep EEGs (one in unit, and one 4 weeks post discharge) for healthy control comparison to preterm infants |
Who may qualify
- Ages
- 26 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infant is between 26/0 and 32/6 weeks gestational age upon admission for the INTERVENTION / STANDARD care group OR 38-42 weeks for the FULL TERM group
- Infant's weight is appropriate for gestational age (AGA)
- Infant is a singleton
- Mother is 18 years of age or older
- Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent) (not applicable for FULL TERM group)
Key exclusion criteria (7 listed)
- Infant's attending does not recommend enrollment in study
- The infant has severe congenital anomalies, including chromosomal anomalies or an Intraventricular Hemorrhage (IVH) Grades 3 and 4
- Mother has known history of substance abuse, severe psychiatric illness or psychosis
- Status of enrolled subject changes and subject no longer falls in inclusion criteria
- Mother and/or infant has a medical condition that precludes intervention components
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 |
|---|---|---|
| Full Term EEGFull-term infants assigned to this arm of the study will receive one sleep EEG (one hour in duration). These EEGs will be used as healthy control comparisons to those of premature infants at 40 weeks. | Other | Full Term EEG |
| Facilitated Infant CareAlso: Family Nurture InterventionFamily Nurture Intervention is facilitated by specially trained Nurture Specialists. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother. | Behavioural | Facilitated infant care |
Primary outcome
EEG measures of power and coherence
Time frame: 34 weeks gestational age through term age
Two one-hour sleep EEGs will take place. One at 34-36 weeks Gestational Age, and one at term age
9 secondary outcomes
Maternal measures of anxiety, depression and care-giving
Time frame: Up to 12 months of age
Measure of mother time spent with infant in unit and in skin to skin
Time frame: Duration of infant stay in unit (roughly 35 days)
Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III
Time frame: Up to 12 month corrected age
Physiological Assessments- salivary cortisol
Time frame: Up to 24 months corrected age
Physiological Assessments- breast milk
Time frame: The duration of the infant stay in unit, or an average of 5 weeks
Physiological Assessments- infant stool collection
Time frame: The duration of the infant stay in unit, or an average of 5 weeks
Physiological Assessments- infant blood samples
Time frame: The duration of the infant stay in unit, or an average of 5 weeks
Mother-Infant Interactions Assessments: Evaluating the qualities of the mother's interaction with her infant during diaper change
Time frame: Up to 4 months corrected age
Mother-Infant Interaction Assessments: Mother-infant face-to-face communicative competence, sensitivity of maternal caregiving and mother and infant physiological capacity to cope with a stressor
Time frame: Up to 12 months corrected age
Results and safety
The study was stopped early (reason given: insufficient enrollment numbers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Background: PubMed 21371754Ravn IH, Smith L, Lindemann R, Smeby NA, Kyno NM, Bunch EH, Sandvik L. Effect of early intervention on social interaction between mothers and preterm infants at 12 months of age: a randomized controlled trial. Infant Behav Dev. 2011 Apr;34(2):215-25. doi: 10.1016/j.infbeh.2010.11.004. Epub 2011 Mar 2.
- Background: PubMed 15324994Muller-Nix C, Forcada-Guex M, Pierrehumbert B, Jaunin L, Borghini A, Ansermet F. Prematurity, maternal stress and mother-child interactions. Early Hum Dev. 2004 Sep;79(2):145-58. doi: 10.1016/j.earlhumdev.2004.05.002.
- Background: PubMed 21067812Meijssen D, Wolf MJ, van Bakel H, Koldewijn K, Kok J, van Baar A. Maternal attachment representations after very preterm birth and the effect of early intervention. Infant Behav Dev. 2011 Feb;34(1):72-80. doi: 10.1016/j.infbeh.2010.09.009. Epub 2010 Nov 9.
- Background: PubMed 20345840Meijssen D, Wolf MJ, Koldewijn K, Houtzager BA, van Wassenaer A, Tronick E, Kok J, van Baar A. The effect of the Infant Behavioral Assessment and Intervention Program on mother-infant interaction after very preterm birth. J Child Psychol Psychiatry. 2010 Nov;51(11):1287-95. doi: 10.1111/j.1469-7610.2010.02237.x.
- Background: PubMed 21242223Shah PE, Clements M, Poehlmann J. Maternal resolution of grief after preterm birth: implications for infant attachment security. Pediatrics. 2011 Feb;127(2):284-92. doi: 10.1542/peds.2010-1080. Epub 2011 Jan 17.
- Background: PubMed 17449102Coppola G, Cassibba R, Costantini A. What can make the difference? Premature birth and maternal sensitivity at 3 months of age: the role of attachment organization, traumatic reaction and baby's medical risk. Infant Behav Dev. 2007 Dec;30(4):679-84. doi: 10.1016/j.infbeh.2007.03.004. Epub 2007 Apr 20.
- Background: PubMed 6745974DeBoer RW, Karemaker JM, Strackee J. Comparing spectra of a series of point events particularly for heart rate variability data. IEEE Trans Biomed Eng. 1984 Apr;31(4):384-7. doi: 10.1109/TBME.1984.325351. No abstract available.
- Background: PubMed 3608643Hofer MA. Early social relationships: a psychobiologist's view. Child Dev. 1987 Jun;58(3):633-47.
- Background: PubMed 8078162Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG. Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects. JAMA. 1994 Sep 21;272(11):853-8.
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Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Martha G Welch, MD principal investigator
Columbia University Medical Center, Presbyterian Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Term EEG and Facilitated Infant Care in people with Premature Birth, run by Columbia University at 2 sites 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 7 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: stopped early, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: insufficient enrollment numbers). Results are not available in the source record.
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?
EEG measures of power and coherence (time frame: 34 weeks gestational age through term age). 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 NCT02352142, which also lists 9 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 26 Sep 2016.