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A Language Intervention Study of Preterm Infants

NCT03688386 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Betty Vohr, MD · Women and Infants Hospital of Rhode Island

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2020-03-03
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688386 on ClinicalTrials.gov