NCT01281566

A Study of Cisapride in Premature Infants With Feeding Problems

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 36 Weeks – 99 Weeks
• Healthy volunteers: Not accepted

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).

Conditions

• Infant, Premature
• Infant, Newborn

Interventions

Type	Name	Description
DRUG	Placebo	liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days
DRUG	Cisapride	0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days

Timeline

• Start date: 2003-03-01
• Completion: 2003-07-01
• First posted: 2011-01-24
• Last updated: 2011-01-24