An interventional study of Reading intervention and Infant bonding in Language Development, Language Delay and Mother-Infant Interaction, sponsored by Women and Infants Hospital of Rhode Island. Status unknown at 1 site in United States. Open to participants aged 23 Weeks to 31 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Prevention
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.
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.
114 studies on the registry are indexed under Language Development Disorders; 47 are open to participants now.
This study's enrollment of 67 is close to the median of 71 across 100 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 92 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Behavioral: Reading intervention · Behavioral: Infant bonding · Behavioral: LENA recording · Behavioral: LENA linguistic feedback
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
Behavioral: Infant bonding · Behavioral: LENA recording · Behavioral: LENA summary
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.
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.
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 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.
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.
LENA Counts
Adult word counts, conversational turns, and infant vocalizations from each recording
Time frame: Change from 32 week language counts to 36 week language counts
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.
Time frame: 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.
Time frame: 12 months and 24 months
Maternal Well-Being
Using the Fragile Infant Parent Readiness Evaluation survey to evaluate maternal well-being
Time frame: 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
Time frame: 36 weeks and 12 months
DNA methylation
Understand DNA methylation pattern differences of genes of before and after study participation.
Time frame: Enrollment and 36 weeks
Plan to share: No
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Language Development Disorders→
Women and Infants Hospital of Rhode Island