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Clinical Trials/NCT03688386
NCT03688386
Unknown
Not Applicable

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

Women and Infants Hospital of Rhode Island1 site in 1 country67 target enrollmentDecember 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Language Development
Sponsor
Women and Infants Hospital of Rhode Island
Enrollment
67
Locations
1
Primary Endpoint
LENA Counts
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2018
End Date
June 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Women and Infants Hospital of Rhode Island
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Perception of reading and infant bonding(36 weeks and 12 months)
  • Neonatal Intensive Care Unit Network Neurobehavioral Scale profile(36 weeks)
  • Maternal Well-Being(36 weeks)
  • Bayley Scales of Infant and Toddler Development, Third Edition(12 months and 24 months)

Study Sites (1)

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