Overview

A Study of Cisapride in Premature Infants With Feeding Problems

Status:
Terminated
Trial end date:
2003-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatments:
Cisapride
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)