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swaddle blanket for Gastroesophageal Reflux Disease

N/A
Waitlist Available
Led By Mary T Carbone, MD
Research Sponsored by Valley Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- NICU patients who have a 5 channel study requested by the attending neonatologist -
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Gastroesophageal Reflux Disease
  • Bradycardia
  • Apnea
  • Slow Heart Rate
  • Acid Reflux
  • Oxygen Saturation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
pH
Secondary study objectives
apnea
Other study objectives
bradycardia
oxygen desaturations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: swaddle blanketExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Valley Health SystemLead Sponsor
9 Previous Clinical Trials
1,843 Total Patients Enrolled
Mary T Carbone, MDPrincipal InvestigatorThe Valley Hospital
~4 spots leftby Nov 2025
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