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Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease (SUPPRESS-CHD)

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ClinicalTrials.gov Identifier: NCT03667703
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Kimberly I. Mills, MD, Boston Children’s Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Upper Gastrointestinal Bleeding Stress Ulcer Infection Drug: Ranitidine Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, double-blinded randomized placebo-controlled pilot feasibility trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Stress Ulcer Prophylaxis Versus Placebo - a Blinded Randomized Control Trial to Evaluate the Safety of Two Strategies in Critically Ill Infants With Congenital Heart Disease
Actual Study Start Date : March 10, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects randomized to placebo will receive an equivalent volume (mL) of normal saline intravenously or stevioside sugar-free syrup vehicle orally based on weight and age.
Drug: Placebo
Patients will be randomized to either receive a placebo or ranitidine (study drug).

Active Comparator: Study Drug
Subjects randomized to study drug will receive ranitidine, a histamine-2 receptor antagonist. Dosing will be weight based and age-dependent. Neonates (<30 days old) will receive either 1mg/kg intravenously daily or 2mg/kg orally twice a day of ranitidine. Infants (30 days or older) will receive 1mg/kg intravenously twice a day or 1mg/kg orally twice a day.
Drug: Ranitidine
Patients will be randomized to either receive a placebo or ranitidine (study drug).




Primary Outcome Measures :
  1. Predefined Feasibility Outcomes to Assess Trial Success [ Time Frame: Through study completion, anticipated 2 years. ]
    Feasibility will be defined by the following metrics: (1) if >80% of eligible patients are approached for consent (screening), (2) >20% of eligible patients are randomized (consent and enrollment), (3) >80% of enrolled patients received first dose of study drug within 48 hours (allocation), and (4) >80% compliance to protocol and treatment group (protocol adherence).

  2. Rate of upper gastrointestinal bleeds [ Time Frame: Through study completion, anticipated 2 years. ]
    To examine the difference in the incidence of clinically significant upper gastrointestinal (UGI) bleeding in critically ill infants with CHD receiving SUP versus placebo to demonstrate safety.


Secondary Outcome Measures :
  1. Microbiome alterations [ Time Frame: Through study completion, anticipated 2 years. ]
    To compare the absolute and serial differences in the abundance of bacteria and functional microbial profiles in the aerodigestive tract between critically ill infants with CHD receiving SUP compared to placebo.

  2. Rate of hospital-acquired infections [ Time Frame: Through study completion, anticipated 2 years. ]
    To examine the difference in the incidence of hospital-acquired infections in critically ill infants with CHD receiving SUP versus placebo. Hospital-acquired infections include ventilator-associated pneumonia, central line-associated bloodstream infections, catheter-associated urinary tract infections, superficial sternal infection, or mediastinitis.



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. < 12 months of age (including premature newborns),
  2. diagnosed with congenital heart disease (including anatomic, myopathic and arrhythmic conditions),
  3. received ≤ 1 dose of SUP (including histamine-2 receptor antagonists, proton pump inhibitors, and sucralfate) during current admission, AND
  4. anticipated to require respiratory support for > 24 hours during their CICU stay. Respiratory support includes mechanical ventilation, non-invasive positive-pressure ventilation and high-flow oxygen therapy.

Exclusion Criteria:

  1. prior use of antacids (including histamine-2 receptor antagonists, proton pump inhibitors, or sucralfate) in the past month for > 7 days,
  2. active gastrointestinal bleeding,
  3. active Helicobacter pylori infection,
  4. administration of high-dose steroids (equivalent dosing to 15 mg/kg/day of methylprednisolone),
  5. will receive ketorolac (intravenous nonsteroidal anti-inflammatory drug) during admission,
  6. exposed to specific anticoagulants (high-dose aspirin, direct thrombin inhibitors and GPIIbIIIa inhibitors),
  7. planned to undergo or recently has undergone gastrointestinal surgery (i.e. repair of duodenal atresia)
  8. supported by extracorporeal membrane oxygenator (ECMO) or ventricular assist device (VAD),
  9. currently enrolled in another intervention trial,
  10. known to be allergic to H2RAs,
  11. admitted for palliative care,
  12. prior enrollment in the study, OR
  13. primary provider declines enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667703


Contacts
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Contact: Kimberly I Mills, MD 617-355-7866 kimberly.mills@cardio.chboston.org
Contact: Ben D Albert, MD 617-355-7866 ben.albert@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kimberly I Mills, MD    617-355-7866    kimberly.mills@cardio.chboston.org   
Contact: Ben D Albert, MD    617-355-7866    ben.albert@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital
The Gerber Foundation
Investigators
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Principal Investigator: Kimberly I Mills, MD Boston Children’s Hospital
Principal Investigator: Ben D Albert, MD Boston Children’s Hospital
Principal Investigator: Nilesh M Mehta, MD Boston Children’s Hospital

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Responsible Party: Kimberly I. Mills, MD, Assistant in Cardiology, Instructor in Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03667703     History of Changes
Other Study ID Numbers: IRB-P00028715
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Heart Diseases
Heart Defects, Congenital
Ulcer
Cardiovascular Diseases
Pathologic Processes
Hemorrhage
Cardiovascular Abnormalities
Congenital Abnormalities
Gastrointestinal Diseases
Digestive System Diseases
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs