Impact of Swaddle Blanket on Gastroesophageal Reflux

Gastroesophageal Reflux Clinical Trial

Official title:

Impact of Swaddle Blanket on Gastroesophageal Reflux

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02083952
• Other study ID #: 20131959
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2014
• Last updated: January 19, 2015
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Valley Health System
• Contact: Mary T Carbone, MD
• Phone: 201-447-8152
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 180 Days

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Bradycardia
• Gastroesophageal Reflux
• Oxygen Desaturations

Intervention

Other:
• Swaddle Blanket
Two arms involve varying time spent in blanket

Locations

Country	Name	City	State
United States	The Valley Hospital	Ridgewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Valley Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bradycardia	all heart rate drops below 80 beats per minute will be noted	24 hours	No
Other	oxygen desaturations	all oxygen drops below 92% will be noted	24 hours	No
Primary	pH	all epochs of pH values below 4.0 will be measured	24 hours	No
Secondary	apnea	all breathing pauses greater than 20 seconds will be noted	24 hours	No