NCT03688386

A Language Intervention Study of Preterm Infants

Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: All
• Age: 23 Weeks – 31 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Language Development
• Language Delay
• Mother-Infant Interaction
• Maternal Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Reading intervention	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.
BEHAVIORAL	Infant bonding	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.
BEHAVIORAL	LENA recording	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.
BEHAVIORAL	LENA linguistic feedback	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.
BEHAVIORAL	LENA summary	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.

Timeline

• Start date: 2018-12-04
• Primary completion: 2020-03-03
• Completion: 2021-06-30
• First posted: 2018-09-28
• Last updated: 2020-10-08

Locations

1 site across 1 country: United States