A Study of Cisapride in Premature Infants With Feeding Problems

Phase 4

Terminated

• Conditions: Infant, Premature; Infant, Newborn
• Interventions: Drug: Placebo; Drug: Cisapride

• Registration Number: NCT01281566
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.

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).

Study Timeline

• Study Start: 2003-03
• Study Completion: 2003-07
• Status Verified: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Last Update Submitted: 2011-01-20
• Study First Posted: 2011-01-24
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
002	Placebo	Placebo liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days
001	Cisapride	Cisapride 0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days

Primary Outcome Measures

Name	Time	Method
Time from start of study medication to full enteral feeding	Up to 42 days

Secondary Outcome Measures

Name	Time	Method
Number and type of adverse events	Up to 42 days