A Study of Cisapride in Premature Infants With Feeding Problems
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infant, Premature; Infant, Newborn
Intervention: Placebo (Drug); Cisapride (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Summary
The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding
problems in premature newborn infants.
Clinical Details
Official title: Double-blind, Randomized, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2mg/kg q.i.d) for the Treatment of Feeding Intolerance in Premature Infants
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Time from start of study medication to full enteral feeding
Secondary outcome: Number and type of adverse events
Detailed description:
This is a double-blind study where the identity of the treatment assigned (Cisapride or
placebo) will not be known to the patient's legal guardian or any study staff involved with
the study. Patients will be randomized (assigned by chance) to receive either the drug
Cisapride or a placebo (a placebo is identical in appearance to Cisapride but does not
contain Cisapride or any active drug) to see if Cisapride is effective in improving feeding
problems (referred to as feeding intolerance) in premature newborn infants who cannot
tolerate oral feeding by mouth or through a tube going directly to the stomach or intestine.
Patients will be given either cisapride at a dose of 0. 2 mg/kg or placebo as a liquid
suspension through a tube from the nose to the stomach (referred to as a nasogastric tube)
15 minutes before feeding once every 6 hours (or 4 times a day referred to as a q. i.d.
schedule).
Eligibility
Minimum age: 36 Weeks.
Maximum age: 99 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must be hospitalized and on continuous cardiac monitoring for the duration of the
study
- Patient has demonstrated feeding intolerance as defined by the protocol
- Patient's parent or legal guardian must sign the informed consent form
Exclusion Criteria:
- Currently active significant cardiovascular disease, as determined by the
neonatologist/physician, including congenital heart disease and heart block (patent
ductus arteriosus without cardiac compromise at the time of randomization is
acceptable)
Locations and Contacts
Additional Information
Starting date: March 2003
Last updated: January 20, 2011
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