CompletedNot Applicable

CTICU Pacifier Activated Music Player and Mother's Voice

United States61 participantsStarted 2016-09-15

Plain-language 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.

Who can participate

Age range0 Months – 6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants that have a diagnosis of a complex congenital heart defect and scheduled for a surgical intervention; meet CTICU feeding guidelines criteria. Infants with acquired brain injury will be included, as well as those whose mothers speak languages other than English. Exclusion Criteria: * Infants that are on assisted ventilation, continuous positive airway pressure, general anesthesia within 24 hours; lethal congenital abnormalities or congenital brain malformation.

What they're measuring

Oral feeding Efficiency

Timeframe: Depending on randomization, 5 days pre-operation (group 1) or 5 days post-operation (group 2)

Trial details

NCT IDNCT03035552

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-31

View on ClinicalTrials.gov More Heart Defects, Congenital trials