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Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy

NCT03230032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-09-13

No results posted yet for this study

Summary

The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition suck-strength and rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for CP.

Conditions

  • Infant Development
  • Infant,Premature
  • Hydrocephalus
  • Neonatal Encephalopathy
  • Infarction
  • PVL
  • Thrombosis
  • Intraventricular Hemorrhage

Interventions

DEVICE

pacifier-activated device

The utilization of the pacifier-activated-music player combines the sound of the mother's voice with a pacifier routinely used with each patient during their inpatient NICU stay

Sponsors & Collaborators

  • Cerebral Palsy Alliance

    collaborator OTHER

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Nathalie L Maitre, MD, PhD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2021-07-31
Completion
2021-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03230032 on ClinicalTrials.gov