NCT01281566

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2011

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

January 20, 2011

Last Update Submit

January 20, 2011

Conditions

Infant, PrematureInfant, Newborn

Keywords

Cisapride (Prepulsid)Feeding intoleranceEnteral feedingNasogastric tubeNeonate

Outcome Measures

Primary Outcomes (1)

  • Time from start of study medication to full enteral feeding

    Up to 42 days

Secondary Outcomes (1)

  • Number and type of adverse events

    Up to 42 days

Study Arms (2)

001

EXPERIMENTAL

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

Drug: Cisapride

002

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PlaceboDRUG

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

002
CisaprideDRUG

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

001

Eligibility Criteria

Age36 Weeks - 99 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Interventions

Cisapride

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 24, 2011

Study Start

March 1, 2003

Study Completion

July 1, 2003

Last Updated

January 24, 2011

Record last verified: 2011-01