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Histamine H2 Receptor Antagonist
Study Drug for Upper Gastrointestinal Bleeding (SUPPRESS-CHD Trial)
Phase 4
Waitlist Available
Led By Kimberly I Mills, MD
Research Sponsored by Boston Children's Hospital
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 through study completion, anticipated 2 years.
Awards & highlights
SUPPRESS-CHD Trial Summary
This study is evaluating whether stress ulcer prophylaxis is safe for infants with congenital heart disease.
Eligible Conditions
- Upper Gastrointestinal Bleeding
- Stress Ulcers
- Infections
- Congenital Heart Disease
SUPPRESS-CHD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, anticipated 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, anticipated 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Predefined Feasibility Outcomes to Assess Trial Success
Rate of upper gastrointestinal bleeds
Secondary outcome measures
Microbiome alterations
Rate of hospital-acquired infections
SUPPRESS-CHD Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Study DrugActive Control1 Intervention
Subjects randomized to study drug will receive famotidine, a histamine-2 receptor antagonist. Dosing will be weight based and age-dependent. Infants < 90 days old will receive either 0.5mg/kg intravenously daily or 0.5mg/kg orally twice a day of famotidine. Infants ≥ 90 days or older will receive 0.25mg/kg intravenously every 12 hours or 0.5mg/kg orally twice a day.
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomized to placebo will receive an equivalent volume (mL) of normal saline intravenously or Ora-plus orally based on weight and age.
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
760 Previous Clinical Trials
5,579,610 Total Patients Enrolled
The Gerber FoundationOTHER
41 Previous Clinical Trials
5,926 Total Patients Enrolled
Kimberly I Mills, MDPrincipal InvestigatorBoston Children's Hospital
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