Early Versus Late Use of Ibuprofen for PDA Closure

Prematurity Clinical Trial

Official title: Early vs. Late Use of Ibuprofen for PDA Closure and Pain/Stress Reduction

Status Terminated

Clinical Trial Summary

The primary objective is to evaluate the 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.

The secondary objective is to measure the stress hormone and metabolic response (plasma catecholamines, glucose, and lactate) of neonates undergoing Ibu treatment of the PDA. The investigators believe that early ibuprofen will blunt the stress response greater than later use.

Clinical Trial Description

Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a 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.

Stress response will be evaluated by drawing catecholamines, glucose, and lactate at one hour prior to initial dose of ibuprofen, and then at 1 and 6 hours post initial ibuprofen dose. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus
• Prematurity

• NCT number: NCT00833365
• Study type: Interventional
• Source: University of Utah
• Status: Terminated
• Phase: N/A
• Start date: January 2009
• Completion date: November 2011