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Completed
NCT02083952
Impact of Swaddle Blanket on Gastroesophageal Reflux
Conditions: Gastroesophageal Reflux, Apnea, Bradycardia, Oxygen Desaturations
Sex: All
Ages: 2 Days – 180 Days
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Valley Health System
Location: The Valley Hospital Ridgewood New Jersey
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.
Eligibility Criteria
Inclusion Criteria:
\- NICU patients who have a 5 channel study requested by the attending neonatologist -
Exclusion Criteria:
\-
Source: ClinicalTrials.gov (NCT02083952). StuddyBuddy aggregates publicly available trial information.
