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Treatment for Acid Reflux (Infant GER Trial)
N/A
Waitlist Available
Led By Ian M Paul, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour observation period
Awards & highlights
Summary
The purpose of this voluntary research study is to evaluate the extent to which infants with Gastroesophageal Reflux (GER) exhibit oxygen desaturation (low oxygen levels in their blood) and bradycardia (slow heart rate) in supine (lying flat on back) and inclined positions.
Eligible Conditions
- Acid Reflux
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour observation period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour observation period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of bradycardia episodes
Number of hypoxic episodes
Number of observed regurgitations
Secondary study objectives
Observed cyanosis episodes
Subjective assessment of crying, hiccups, back arching, and respiratory distress
Subjective maternal perception of infant comfort in each position
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
505 Previous Clinical Trials
2,795,950 Total Patients Enrolled
Iron MountainsUNKNOWN
Ian M Paul, MDPrincipal InvestigatorPenn State College of Medicine
1 Previous Clinical Trials
60 Total Patients Enrolled
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