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Gastroesophageal Reflux | Impact of Swaddle Blanket on Gastroesophageal Reflux

Gastroesophageal Reflux research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - NICU patients who have a 5 channel study requested by the attending neonatologist - Exclusion Criteria:

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Gastroesophageal Reflux

Apnea

Bradycardia

Oxygen Desaturations

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Swaddle BlanketTwo arms involve varying time spent in blanket

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

swaddle blanket

Study Status

Unknown status

Start Date: February 2014

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: pH

Secondary Outcome: apnea

Study sponsors, principal investigator, and references

Principal Investigator: Mary T Carbone, MD

Lead Sponsor: Valley Health System

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02083952

Discuss Bradycardia