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CTICU Pacifier Activated Music Player and Mother's Voice

NCT03035552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-02-07

No results posted yet for this study

Summary

The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS) using contingent positive reinforcement with mother's voice can improve the feeding outcomes of infants with congenital heart defect (CHD) at high risk for oral motor problems.

Conditions

  • Heart Defects, Congenital

Interventions

BEHAVIORAL

Pacifier activated music player

Therefore the immediate goal of the current proposal is to demonstrate that intensive NNS-training using reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD using a randomized controlled trial (RCT) design, with wait-list controls to ensure that infants in the trial all benefit from a treatment with only demonstrated positive effects. Establishment of optimal NNS patterns in the first 6 months after birth in these infants will improve downstream feeding skills and may promote better motor and language outcomes by one year of age.

Sponsors & Collaborators

Principal Investigators

  • Nathalie Maitre, MD. PhD · Perinatal Research Institute, Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-15
Primary Completion
2019-01-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03035552 on ClinicalTrials.gov