Impact of Swaddle Blanket on Gastroesophageal Reflux

June 3, 2026 updated by: Valley Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 5 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: swaddle blanket
Other: Swaddle Blanket
Two arms involve varying time spent in blanket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH
Time Frame: 24 hours
all epochs of pH values below 4.0 will be measured
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apnea
Time Frame: 24 hours
all breathing pauses greater than 20 seconds will be noted
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
bradycardia
Time Frame: 24 hours
all heart rate drops below 80 beats per minute will be noted
24 hours
oxygen desaturations
Time Frame: 24 hours
all oxygen drops below 92% will be noted
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valley Health System

Investigators

  • Principal Investigator: Mary T Carbone, MD, The Valley Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimated)

March 11, 2014

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20131959

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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