Impact of Swaddle Blanket on Gastroesophageal Reflux

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02083952

Enrollment

Registered

2014-03-11

Start date

2014-02-01

Completion date

2015-10-01

Last updated

2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Bradycardia, Gastroesophageal Reflux, Oxygen Desaturations

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.

Interventions

OTHERSwaddle Blanket

Two arms involve varying time spent in blanket

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Eligibility

Sex/Gender

ALL

Age

2 Days to 180 Days

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
pH	24 hours	all epochs of pH values below 4.0 will be measured

Secondary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMary T Carbone, MD

The Valley Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026