Impact of Swaddle Blanket on Gastroesophageal Reflux

Not Applicable

• Conditions: Gastroesophageal Reflux; Bradycardia; Apnea; Oxygen Desaturations
• Interventions: Other: Swaddle Blanket

• Registration Number: NCT02083952
• Lead Sponsor: Valley Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• NICU patients who have a 5 channel study requested by the attending neonatologist -

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
swaddle blanket	Swaddle Blanket	-

Primary Outcome Measures

Name	Time	Method
pH	24 hours	all epochs of pH values below 4.0 will be measured

Secondary Outcome Measures

Name	Time	Method
apnea	24 hours	all breathing pauses greater than 20 seconds will be noted

Trial Locations

Locations (1)

The Valley Hospital; 🇺🇸 Ridgewood, New Jersey, United States