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

NCT ID: NCT00833365

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-11-30

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.

Conditions

Patent Ductus Arteriosus; Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early treatment

Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose

Late treatment

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.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Interventions

Ibuprofen

Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose

Intervention Type: DRUG

Ibuprofen

Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Intervention Type: DRUG

Other Intervention Names

NeoProfen; NeoProfen

Eligibility Criteria

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

• Maximum Eligible Age: 96 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Chan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

31394

Identifier Type: -

Identifier Source: org_study_id