Impact of Swaddle Blanket on Gastroesophageal Reflux | NCT02083952

Studies
Impact of Swaddle Blanket on Gastroesophageal Reflux

NCT02083952

Sponsor

Valley Health System

Status

Completed

Last Update Posted

Jun 5, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Gastroesophageal Reflux
Apnea
Bradycardia
Oxygen Desaturations

Interventions

Swaddle Blanket

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Mar 4, 2014

First Submission Date that Met QC Criteria

Mar 6, 2014

First Posted Date

Mar 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2026

Last Update Posted Date

Jun 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
swaddle blanket	Experimental		Other: Swaddle Blanket

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Swaddle Blanket	Other	Two arms involve varying time spent in blanket	swaddle blanket

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Days

Maximum Age

180 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary T Carbone, MD	The Valley Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Valley Hospital		Ridgewood	New Jersey	07450	United States

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D001049	Apnea
D001919	Bradycardia

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided