Impact of Swaddle Blanket on Gastroesophageal Reflux (NCT02083952) | Clinical Trial Compass
CompletedNot Applicable
Impact of Swaddle Blanket on Gastroesophageal Reflux
United States50 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range
2 Days – 180 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- NICU patients who have a 5 channel study requested by the attending neonatologist -
Exclusion Criteria:
\-
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether swaddle blankets affect gastroesophageal reflux, apnea, bradycardia, and oxygen drops in babies — could swaddling actually be making my baby's reflux or breathing episodes better or worse, and what did this study find?
2Since the trial measured pH levels as its primary outcome, what does pH monitoring tell us about the severity of my baby's reflux, and is that kind of testing something my baby should have?
3This study is completed — has my doctor seen the results, and do they change how they think about using swaddling as part of managing reflux or apnea in babies like mine?
4Since this was a non-drug study looking at positioning and swaddling technique, are there specific swaddling approaches my doctor would recommend or caution against given my baby's combination of reflux and breathing concerns?
5Are there standard treatments or care practices for infant reflux and apnea that my doctor would want to try first, and how does the evidence from this kind of study fit into those recommendations?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.