Infant, Newborn, Infant, Premature
Conditions
Keywords
Cisapride (Prepulsid), Feeding intolerance, Enteral feeding, Nasogastric tube, Neonate
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).
Interventions
DRUGPlacebo
liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days
DRUGCisapride
0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
36 Weeks to 99 Weeks
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from start of study medication to full enteral feeding | Up to 42 days |
Secondary
| Measure | Time frame |
|---|---|
| Number and type of adverse events | Up to 42 days |
Outcome results
None listed