A Study of Cisapride in Premature Infants With Feeding Problems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2003-07-31

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.

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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).

Conditions

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Infant, Premature Infant, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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001

Cisapride 0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days

Group Type EXPERIMENTAL

Cisapride

Intervention Type DRUG

0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days

002

Placebo liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days

Interventions

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Placebo

liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days

Intervention Type DRUG

Cisapride

0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days

Intervention Type DRUG

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)

Minimum Eligible Age

36 Weeks

Maximum Eligible Age

99 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No