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Early Versus Late Use of Ibuprofen for PDA Closure

Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Patent Ductus Arteriosus; Prematurity

Intervention: Ibuprofen (Drug); Ibuprofen (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
Gary Chan, MD, Principal Investigator, Affiliation: University of Utah

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 Details

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

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

Primary outcome: The primary objective is to evaluate the PDA closure rate of early vs. late use of Ibuprofen (Ibu).

Secondary outcome: 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.

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: 96 Hours. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Birth weight less than 1200gm

- Less than 28 weeks gestational age

- Confirmed PDA via echocardiogram and clinical exam

Exclusion Criteria:

- Active Bleeding

- Currently being treated for PPHN

- Cardiac anomalies

- Chromosomal abnormalities

- Endocrine, metabolic, renal, or hepatic disorders

Locations and Contacts

University of Utah, Salt Lake City, Utah 84132, United States
Additional Information

Starting date: January 2009
Last updated: December 10, 2014

Page last updated: August 23, 2015

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