Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure

Not Applicable

Terminated

• Conditions: Patent Ductus Arteriosus; Prematurity
• Interventions: Drug: Ibuprofen

• Registration Number: NCT00833365
• Lead Sponsor: University of Utah

Brief Summary

The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.

Detailed Description

Infants with birth weight at \<1200gm and/or \<28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of \<96 hrs old and \>96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2014-12
• Results First Submitted: 2015-05-01
• Results First Submitted QC: 2016-05-24
• Last Update Submitted: 2016-05-24
• Results First Posted: 2016-07-04
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Birth weight less than 1200gm
• Less than 28 weeks gestational age
• Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

Exclusion Criteria

• Active Bleeding
• Currently being treated for Persistent Pulmonary Hypertension (PPHN)
• Cardiac anomalies
• Chromosomal abnormalities
• Endocrine, metabolic, renal, or hepatic disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early treatment	Ibuprofen	Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Late treatment	Ibuprofen	Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.

Primary Outcome Measures

Name	Time	Method
Number of PDA Closures Related to Treatment With Ibuprofen	Within 48 hrs of ibuprofen round	Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.

Secondary Outcome Measures

Name	Time	Method
Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration	1 and 6 hours

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States