A Study of Cisapride in Premature Infants With Feeding Problems

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

Detailed Description
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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).

Official Title
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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

Conditions
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Infant, Premature, Infant, Newborn

Intervention / Treatment
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* Drug: Placebo
* Drug: Cisapride


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 36 Weeks
Maximum Age: 99 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>Cisapride 0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days | Drug: Cisapride<br>* 0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days<br>|
| Placebo Comparator: 002<br>Placebo liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days | Drug: Placebo<br>* liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from start of study medication to full enteral feeding |  | Up to 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of adverse events |  | Up to 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisapride (Prepulsid), Feeding intolerance, Enteral feeding, Nasogastric tube, Neonate