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COMPLETED
NCT02083952
NA

Impact of Swaddle Blanket on Gastroesophageal Reflux

Sponsor: Valley Health System

View on ClinicalTrials.gov

Summary

Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.

Key Details

Gender

All

Age Range

2 Days - 180 Days

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2014-02

Completion Date

2015-10

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

OTHER

Swaddle Blanket

Two arms involve varying time spent in blanket

Locations (1)

The Valley Hospital

Ridgewood, New Jersey, United States