Language DevelopmentNCT03688386
A Language Intervention Study of Preterm Infants
A study testing Reading intervention, Infant bonding and LENA recording in people with Language Development and Language Delay, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants. Read more about this study
- Who is it for?
- Ages 23 to 31 weeksHealthy volunteers can take part
- Conditions the study is for
- Language Development, Language Delay, Mother-Infant Interaction
- What is being tested?
- Reading intervention, Infant bonding and LENA recording
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 30 Jun 2021
- 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 23 to 31 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 21-31 week infants, medically stable infants, English speaking mothers over 18 years old
Who cannot join
- Intubated or medically unstable, major congenital anomalies, non English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
About this study
Official title: Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU
This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.
Read the detailed description
This project aims to examine how an educational reading intervention in the NICU can impact preterm infant language development and examine the impact of reading on mother-infant autonomic systems. Investigators plan to determine the effects of parent reading in addition to standard caretaking and holding on preterm infants, between 23 to 31 weeks gestation hospitalized in the Women \& Infants NICU, on adult word count, infant vocalizations, conversational turns through audio recording obtained over 3 separate days when the infant is corrected to 32, 34 and 36 weeks. Investigators aim to determine the effect of parent reading on maternal and infant heart rate variability before, during, and after the shared reading intervention through video and a single channel electrocardiographic recording over the same 3 separate days as the LENA recording. Additionally, investigators aim to determine the effect of parent reading on maternal stress and perceived well-being in the NICU through a validated questionnaire and to determine parent satisfaction of a NICU reading intervention through a parent questionnaire completed prior to infant discharge and at the 12 month follow up visit. Secondary outcomes include determining the effect of parent reading on infant DNA methylation of the several genes through two saliva samples collected from the infant prior to study and post study enrollment and examine its relationship with infant stress and self-regulation based on a neurobehavioral exam performed at 36 weeks corrected age. Final outcomes include examination of the long-term effect of inpatient shared reading education on infant receptive and expressive language development at 12 and 24 months. Investigators hope this research will contribute to the growing research supporting early language development in preterm infants and its impact on maternal-infant well-being.
- Being tested
- Reading intervention, Infant bonding, LENA recording, LENA linguistic feedback, LENA summary
- Keywords
- Language intervention, Preterm reading, Heart rate variability, Mother-infant interaction, NICU Network Neurobehavioral Scale, LENA
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading interventionBehavioural
Written packet with 3 lessons. The first lesson includes how to begin to read and talk to their baby. The second lesson includes reading or talking about the day using parentese talk. The third lesson includes continuing to engage with the baby through interactive reading.
Infant bondingBehavioural
Written packet with 3 lessons. The first lesson includes skin-to-skin and learning about their baby. The second lesson includes learning readiness cues and participation in feeding times. The third lesson includes developing routines and playing games.
LENA recordingBehavioural
The LENA device provide 16 hours of language recordings placed inside an infant vest. The recordings are uploaded to a computer which analyzes total adult word counts, infant vocalizations, conversational turns, background noise, and silence.
LENA linguistic feedbackBehavioural
LENA recordings of adult word counts, infant vocalizations, and conversational turns will be provided in printed form after each recording with review of each recording and progress over time.
LENA summaryBehavioural
All 3 LENA recording summaries of adult word counts, infant vocalizations, and conversational turns will be summarized in printed form and provided to mother at discharge.
| Study group | Role | What they receive |
|---|---|---|
| Language Intervention | Experimental | 1. Review language and infant bonding curriculum 2. 1st LENA recording and heart rate variability of mother reading to infant 3. Provide LENA linguistic feedback and review curriculum 4. 2nd LENA recording and heart rate variability of mother reading to infant 5. Provide LENA linguistic feedback and review curriculum 6. 3rd LENA recording and heart rate variability of mother reading to infant 7. Provide LENA linguistic feedback
Assessments: 1. NICU Network Neurobehavioral Scale (NNNS) profile at 36 weeks 2. Fragile Infant Parent Readiness Evaluation at 36 weeks 3. Parent perception survey of reading and curriculum at 36 weeks and 12 months 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months 5. DNA methylation of genes pre and post intervention Receives: Behavioral: Reading intervention; Behavioral: Infant bonding; Behavioral: LENA recording; Behavioral: LENA linguistic feedback |
| Infant bonding | Active comparator | 1. Review infant bonding curriculum with mother 2. 1st LENA recording and heart rate variability of mother holding infant 3. Review infant bonding curriculum 4. 2nd LENA recording and heart rate variability of mother holding infant 5. Review infant bonding curriculum 6. 3rd LENA recording and heart rate variability of mother holding infant 7. Provide linguistic feedback of all 3 LENA recordings
Assessments: 1. NICU Network Neurobehavioral Scale (NNNS) profile at 36 weeks 2. Fragile Infant Parent Readiness Evaluation at 36 weeks 3. Parent perception survey of reading and curriculum at 36 weeks and 12 months 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months 5. DNA methylation of genes pre and post intervention Receives: Behavioral: Infant bonding; Behavioral: LENA recording; Behavioral: LENA summary |
What is being measured
The primary outcome is the main question the study is designed to answer.
LENA Counts
Adult word counts, conversational turns, and infant vocalizations from each recording
Measured: Change from 32 week language counts to 36 week language counts
Secondary outcomes (4)
Neonatal Intensive Care Unit Network Neurobehavioral Scale profile
A validated neurologic assessment of infant neurobehavioral, neurologic and stress responses, and regulatory capacities. The following summary scores and their minimum and maximum scores are as follows: habituation (1-9), attention (1-9), handling (0-1), quality of movement (1-3), regulation (1-9), non optimal reflexes (0-12), asymmetric reflexes (0-7), stress/abstinence (0-1), arousal (1-9), hypertonicity (0-5), hypotonicity (0-3), excitability (0-9), lethargy (0-10). Higher scores indicate the summary score, for example a higher hypertonicity score indicates increased muscle tone whereas a higher hypotonicity score indicates decreased muscle tone. Summary scores are compared to normative scores for high risk preterm infants to compare overall neurobehavior.
Measured: 36 weeks
Bayley Scales of Infant and Toddler Development, Third Edition
Individual assessment used to assess development of infants between 1 to 42 months of age. Domains and their minimum and maximum scores are as follows: adaptive behavioral (40-160), cognitive 55-145), language (47-153), motor (46-154), and social emotional (55-145). Scores can be used to assess infants progress over time.
Measured: 12 months and 24 months
Maternal Well-Being
Using the Fragile Infant Parent Readiness Evaluation survey to evaluate maternal well-being
Measured: 36 weeks
Perception of reading and infant bonding
Parent survey regarding her experience in the NICU with reading, curriculum, and future plans to read to her infant
Measured: 36 weeks and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start4 Dec 2018
- Primary completion3 Mar 2020
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of mother infant pairs to a language curriculum with reading (intervention) or an infant bonding curriculum (control)
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betty Vohr, MD, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688386
- Sponsor's protocol ID
- Pending
- Status last verified
- Oct 2020
- First submitted
- 18 Jun 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20.
PubMed 21767879Lester BM, Marsit CJ, Giarraputo J, Hawes K, LaGasse LL, Padbury JF. Neurobehavior related to epigenetic differences in preterm infants. Epigenomics. 2015 Oct;7(7):1123-36. doi: 10.2217/epi.15.63. Epub 2015 Nov 20.
PubMed 26585459Lariviere J, Rennick JE. Parent picture-book reading to infants in the neonatal intensive care unit as an intervention supporting parent-infant interaction and later book reading. J Dev Behav Pediatr. 2011 Feb-Mar;32(2):146-52. doi: 10.1097/DBP.0b013e318203e3a1.
PubMed 21289497Caskey M, Stephens B, Tucker R, Vohr B. Adult talk in the NICU with preterm infants and developmental outcomes. Pediatrics. 2014 Mar;133(3):e578-84. doi: 10.1542/peds.2013-0104. Epub 2014 Feb 10.
PubMed 24515512
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU
- ClinicalTrials.gov ID
- NCT03688386
- Acronym / sponsor ID
- Pending
- Keywords
- Language intervention, Preterm reading, Heart rate variability, Mother-infant interaction, NICU Network Neurobehavioral Scale, LENA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 28 Sep 2018 (actual)
- 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.
This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.
Detailed description
This project aims to examine how an educational reading intervention in the NICU can impact preterm infant language development and examine the impact of reading on mother-infant autonomic systems. Investigators plan to determine the effects of parent reading in addition to standard caretaking and holding on preterm infants, between 23 to 31 weeks gestation hospitalized in the Women \& Infants NICU, on adult word count, infant vocalizations, conversational turns through audio recording obtained over 3 separate days when the infant is corrected to 32, 34 and 36 weeks. Investigators aim to determine the effect of parent reading on maternal and infant heart rate variability before, during, and after the shared reading intervention through video and a single channel electrocardiographic recording over the same 3 separate days as the LENA recording. Additionally, investigators aim to determine the effect of parent reading on maternal stress and perceived well-being in the NICU through a validated questionnaire and to determine parent satisfaction of a NICU reading intervention through a parent questionnaire completed prior to infant discharge and at the 12 month follow up visit. Secondary outcomes include determining the effect of parent reading on infant DNA methylation of the several genes through two saliva samples collected from the infant prior to study and post study enrollment and examine its relationship with infant stress and self-regulation based on a neurobehavioral exam performed at 36 weeks corrected age. Final outcomes include examination of the long-term effect of inpatient shared reading education on infant receptive and expressive language development at 12 and 24 months. Investigators hope this research will contribute to the growing research supporting early language development in preterm infants and its impact on maternal-infant well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization of mother infant pairs to a language curriculum with reading (intervention) or an infant bonding curriculum (control)
| Arm | Type | Receives |
|---|---|---|
| Language Intervention | Experimental | Behavioral: Reading intervention, Behavioral: Infant bonding, Behavioral: LENA recording, Behavioral: LENA linguistic feedback1. Review language and infant bonding curriculum 2. 1st LENA recording and heart rate variability of mother reading to infant 3. Provide LENA linguistic feedback and review curriculum 4. 2nd LENA recording and heart rate variability of mother reading to infant 5. Provide LENA linguistic feedback and review curriculum 6. 3rd LENA recording and heart rate variability of mother reading to infant 7. Provide LENA linguistic feedback Assessments: 1. NICU Network Neurobehavioral Scale (NNNS) profile at 36 weeks 2. Fragile Infant Parent Readiness Evaluation at 36 weeks 3. Parent perception survey of reading and curriculum at 36 weeks and 12 months 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months 5. DNA methylation of genes pre and post intervention |
| Infant bonding | Active comparator | Behavioral: Infant bonding, Behavioral: LENA recording, Behavioral: LENA summary1. Review infant bonding curriculum with mother 2. 1st LENA recording and heart rate variability of mother holding infant 3. Review infant bonding curriculum 4. 2nd LENA recording and heart rate variability of mother holding infant 5. Review infant bonding curriculum 6. 3rd LENA recording and heart rate variability of mother holding infant 7. Provide linguistic feedback of all 3 LENA recordings Assessments: 1. NICU Network Neurobehavioral Scale (NNNS) profile at 36 weeks 2. Fragile Infant Parent Readiness Evaluation at 36 weeks 3. Parent perception survey of reading and curriculum at 36 weeks and 12 months 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months 5. DNA methylation of genes pre and post intervention |
Who may qualify
- Ages
- 23 to 31 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 21-31 week infants, medically stable infants, English speaking mothers over 18 years old
Key exclusion criteria (1 listed)
- Intubated or medically unstable, major congenital anomalies, non English speaking
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 |
|---|---|---|
| Reading interventionWritten packet with 3 lessons. The first lesson includes how to begin to read and talk to their baby. The second lesson includes reading or talking about the day using parentese talk. The third lesson includes continuing to engage with the baby through interactive reading. | Behavioural | Language Intervention |
| Infant bondingWritten packet with 3 lessons. The first lesson includes skin-to-skin and learning about their baby. The second lesson includes learning readiness cues and participation in feeding times. The third lesson includes developing routines and playing games. | Behavioural | Infant bonding, Language Intervention |
| LENA recordingThe LENA device provide 16 hours of language recordings placed inside an infant vest. The recordings are uploaded to a computer which analyzes total adult word counts, infant vocalizations, conversational turns, background noise, and silence. | Behavioural | Infant bonding, Language Intervention |
| LENA linguistic feedbackLENA recordings of adult word counts, infant vocalizations, and conversational turns will be provided in printed form after each recording with review of each recording and progress over time. | Behavioural | Language Intervention |
| LENA summaryAll 3 LENA recording summaries of adult word counts, infant vocalizations, and conversational turns will be summarized in printed form and provided to mother at discharge. | Behavioural | Infant bonding |
Primary outcome
LENA Counts
Time frame: Change from 32 week language counts to 36 week language counts
Adult word counts, conversational turns, and infant vocalizations from each recording
4 secondary outcomes
Neonatal Intensive Care Unit Network Neurobehavioral Scale profile
Time frame: 36 weeks
Bayley Scales of Infant and Toddler Development, Third Edition
Time frame: 12 months and 24 months
Maternal Well-Being
Time frame: 36 weeks
Perception of reading and infant bonding
Time frame: 36 weeks and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 21767879Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20.
- Background: PubMed 26585459Lester BM, Marsit CJ, Giarraputo J, Hawes K, LaGasse LL, Padbury JF. Neurobehavior related to epigenetic differences in preterm infants. Epigenomics. 2015 Oct;7(7):1123-36. doi: 10.2217/epi.15.63. Epub 2015 Nov 20.
- Background: PubMed 21289497Lariviere J, Rennick JE. Parent picture-book reading to infants in the neonatal intensive care unit as an intervention supporting parent-infant interaction and later book reading. J Dev Behav Pediatr. 2011 Feb-Mar;32(2):146-52. doi: 10.1097/DBP.0b013e318203e3a1.
- Results publication: PubMed 24515512Caskey M, Stephens B, Tucker R, Vohr B. Adult talk in the NICU with preterm infants and developmental outcomes. Pediatrics. 2014 Mar;133(3):e578-84. doi: 10.1542/peds.2013-0104. Epub 2014 Feb 10.
- Individual participant dataSharing planned: No
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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.
Betty Vohr, MD principal investigator
Women and Infants Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading intervention, Infant bonding and LENA recording in people with Language Development and Language Delay, run by Women and Infants Hospital of Rhode Island 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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?
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?
LENA Counts (time frame: Change from 32 week language counts to 36 week language counts). 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 NCT03688386, which also lists 4 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 8 Oct 2020.