NCT02083952

Impact of Swaddle Blanket on Gastroesophageal Reflux

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Valley Health System · Academic / Other
• Sex: All
• Age: 2 Days – 180 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux
• Apnea
• Bradycardia
• Oxygen Desaturations

Interventions

Type	Name	Description
OTHER	Swaddle Blanket	Two arms involve varying time spent in blanket

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-03-11
• Last updated: 2015-01-21

Locations

1 site across 1 country: United States