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A Language Intervention Study of Preterm Infants

Primary Purpose

Language Development, Language Delay, Mother-Infant Interaction

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reading intervention
Infant bonding
LENA recording
LENA linguistic feedback
LENA summary
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Language Development focused on measuring Language intervention, Preterm reading, Heart rate variability, Mother-infant interaction, NICU Network Neurobehavioral Scale, LENA

Eligibility Criteria

23 Weeks - 31 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 21-31 week infants, medically stable infants, English speaking mothers over 18 years old

Exclusion Criteria:

  • Intubated or medically unstable, major congenital anomalies, non English speaking

Sites / Locations

  • Women and Infants Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Language Intervention

Infant bonding

Arm Description

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

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

Outcomes

Primary Outcome Measures

LENA Counts
Adult word counts, conversational turns, and infant vocalizations from each recording

Secondary Outcome Measures

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.
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.
Maternal Well-Being
Using the Fragile Infant Parent Readiness Evaluation survey to evaluate maternal well-being
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

Full Information

First Posted
June 18, 2018
Last Updated
October 6, 2020
Sponsor
Women and Infants Hospital of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT03688386
Brief Title
A Language Intervention Study of Preterm Infants
Official Title
Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women and Infants Hospital of Rhode Island

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development, Language Delay, Mother-Infant Interaction, Maternal Behavior
Keywords
Language intervention, Preterm reading, Heart rate variability, Mother-infant interaction, NICU Network Neurobehavioral Scale, LENA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization of mother infant pairs to a language curriculum with reading (intervention) or an infant bonding curriculum (control)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Language Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Infant bonding
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Reading intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Infant bonding
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LENA recording
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LENA linguistic feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LENA summary
Intervention Description
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.
Primary Outcome Measure Information:
Title
LENA Counts
Description
Adult word counts, conversational turns, and infant vocalizations from each recording
Time Frame
Change from 32 week language counts to 36 week language counts
Secondary Outcome Measure Information:
Title
Neonatal Intensive Care Unit Network Neurobehavioral Scale profile
Description
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.
Time Frame
36 weeks
Title
Bayley Scales of Infant and Toddler Development, Third Edition
Description
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.
Time Frame
12 months and 24 months
Title
Maternal Well-Being
Description
Using the Fragile Infant Parent Readiness Evaluation survey to evaluate maternal well-being
Time Frame
36 weeks
Title
Perception of reading and infant bonding
Description
Parent survey regarding her experience in the NICU with reading, curriculum, and future plans to read to her infant
Time Frame
36 weeks and 12 months
Other Pre-specified Outcome Measures:
Title
DNA methylation
Description
Understand DNA methylation pattern differences of genes of before and after study participation.
Time Frame
Enrollment and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
31 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 21-31 week infants, medically stable infants, English speaking mothers over 18 years old Exclusion Criteria: Intubated or medically unstable, major congenital anomalies, non English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Vohr, MD
Organizational Affiliation
Women and Infants Hospital of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women and Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21767879
Citation
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.
Results Reference
background
PubMed Identifier
26585459
Citation
Lester 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.
Results Reference
background
PubMed Identifier
21289497
Citation
Lariviere 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 Reference
background
PubMed Identifier
24515512
Citation
Caskey 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.
Results Reference
result

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A Language Intervention Study of Preterm Infants

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