A Language Intervention Study of Preterm Infants

Status Active, not recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03688386
Study type	Interventional
Source	Women and Infants Hospital of Rhode Island
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 4, 2018
Completion date	June 30, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.