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Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease

NCT03667703 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-09-21

No results posted yet for this study

Summary

Infants with congenital heart disease often require an intervention during their first year of life. Infants are generally admitted to a cardiac intensive care unit and are routinely prescribed stress ulcer prophylaxis to decrease acid release from the stomach to prevent stress ulcer formation. However, these medicines may not be safe and could put infants at increased risk for hospital-acquired infections, necrotizing enterocolitis and alteration to the infant's microbiome. The investigators plan to assess the feasibility of conducting a prospective, blinded randomized control trial to determine the safety of withholding stress ulcer prophylaxis in critically ill infants with congenital heart disease. In addition, the investigators plan to examine the changes to the infant's microbiome through oral, gastric and stool samples and compare hospital-acquired infections.

Conditions

  • Congenital Heart Disease
  • Upper Gastrointestinal Bleeding
  • Stress Ulcer
  • Infection

Interventions

DRUG

Famotidine

Patients will be randomized to either receive a placebo or famotidine (study drug).

DRUG

Placebo

Patients will be randomized to either receive a placebo or famotidine (study drug).

Sponsors & Collaborators

Principal Investigators

  • Kimberly I Mills, MD · Boston Children's Hospital

  • Ben D Albert, MD · Boston Children's Hospital

  • Nilesh M Mehta, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-10
Primary Completion
2022-06-30
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03667703 on ClinicalTrials.gov