Impact of Swaddle Blanket on Gastroesophageal Reflux

Valley Health System

Status: Unknown

Conditions: Bradycardia; Oxygen Desaturations; Apnea; Gastroesophageal Reflux

Treatments: Other: Swaddle Blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT02083952

20131959

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 180 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

swaddle blanket

Experimental group

Treatment:

Other: Swaddle Blanket