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OpenTrials
Completed

NCT Number: NCT02083952

Impact of Swaddle Blanket on Gastroesophageal Reflux

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.

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Key information

Conditions

Gastroesophageal Reflux Apnea Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Heart Diseases Oxygen Desaturations Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

2 day–180 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Swaddle Blanket

Other

Two arms involve varying time spent in blanket

Primary outcomes

  1. pH

    Time frame: 24 hours

    all epochs of pH values below 4.0 will be measured

Secondary outcomes

  1. apnea

    Time frame: 24 hours

    all breathing pauses greater than 20 seconds will be noted

Other outcomes

  1. bradycardia

    Time frame: 24 hours

    all heart rate drops below 80 beats per minute will be noted

  2. oxygen desaturations

    Time frame: 24 hours

    all oxygen drops below 92% will be noted

Sponsors and collaborators

Lead sponsor

Valley Health System

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 11, 2014
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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