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Effects of Swaddling on Infants During Feeding

NCT02661360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-27

No results posted yet for this study

Summary

The purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm. Results from research will have implication on neurobehavioral and physiologic outcomes as important indicators for the possible effect of swaddling during bottle feeding.

Conditions

  • Premature Birth

Interventions

BEHAVIORAL

Swaddling Intervention for Preterm Infants

Procedure for swaddling includes folding one corner of the blanket down two thirds of the way down the blanket in order to make the blanket into a triangular shape. The infant will be positioned with shoulders at the fold of the blanket. The infant will be positioned with the blanket so that elbows, hips, and knees flexed with hands near the face by wrapping one side of the blanket across the chest holding the hands in place, pulling the bottom corner up toward the infant's face, and securing the blanket with the last corner pulled across the infant's chest again and around their back. The blanket will be tight enough to keep extremities in place but one finger will be able to be placed between the infant and the blanket.

BEHAVIORAL

Unswaddled Control

Procedure for control is blanket loosely draped across the infant without providing containment and without touching the anterior surface of the infant.

Sponsors & Collaborators

Principal Investigators

  • Steve Vanlew, MD · New York University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-04-30
Completion
2016-04-30

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 NCT02661360 on ClinicalTrials.gov