Status:

COMPLETED

Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

Lead Sponsor:

University of California, San Francisco

Conditions:

Patent Ductus Arteriosus

Eligibility:

All Genders

23-33 years

Phase:

NA

Brief 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 shor...

Detailed Description

This study is a randomized controlled multi-center clinical trial to determine whether very low birth weight infants should receive feedings during indomethacin or ibuprofen treatment of a patent duct...

Eligibility Criteria

Inclusion

  • Infants between 401-1,250 g birth weight who
  • Are receiving or are scheduled to begin enteral feedings and
  • Are about to receive pharmacologic treatment (either indomethacin or ibuprofen) to close their PDA.

Exclusion

  • Serious congenital malformations
  • Chromosomal anomalies
  • Congenital or acquired gastrointestinal anomalies
  • Prior episode of necrotizing enterocolitis
  • Use of inotropic support for hypotension
  • Renal anomalies or disease
  • Are receiving \> 80 ml/kg/d of enteral feeding

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2012

Estimated Enrollment :

177 Patients enrolled

Trial Details

Trial ID

NCT00728117

Start Date

July 1 2008

End Date

September 1 2012

Last Update

November 9 2012

Active Locations (14)

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Page 1 of 4 (14 locations)

1

University of California san Francisco

San Francisco, California, United States, 94143

2

Santa Clara Valley Medical Center

San Jose, California, United States, 95128

3

Children's Memorial Hospital-Northwestern University

Chicago, Illinois, United States, 60614

4

North Shore University Health System, Northwestern University

Evanston, Illinois, United States, 60201