A Study of Cisapride in Premature Infants With Feeding Problems

Infant, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01281566
• Other study ID #: CR003955
• Secondary ID: CIS-INT-28
• Status: Terminated
• Phase: Phase 4
• First received: January 20, 2011
• Last updated: January 20, 2011
• Start date: March 2003
• Est. completion date: July 2003

Study information

• Verified date: January 2011
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Weeks to 99 Weeks

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant, Newborn
• Infant, Premature
• Premature Birth

Intervention

Drug:
• Placebo
liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days
• Cisapride
0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from start of study medication to full enteral feeding		Up to 42 days	No
Secondary	Number and type of adverse events		Up to 42 days	No