MedTrace Logo

Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

NCT00728117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2012-11-09

No results posted yet for this study

Summary

We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that infants need to tolerate full enteral nutrition. We also hypothesize that this intervention will minimize the alterations in intestinal permeability that occur with these drugs and will improve the infants' hemodynamic response to enteral nutrition

Conditions

  • Patent Ductus Arteriosus

Interventions

OTHER

feeding

Study infants will receive trophic enteral nutrition (15 ml/kg/day) during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.

OTHER

fasting

Study infants will be fasted during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.

Sponsors & Collaborators

Principal Investigators

  • Ronald Clyman, M.D. · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-07-31
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00728117 on ClinicalTrials.gov