Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Salt Lake City, Utah 84132


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00833365


Primary Contact:

Principal Investigator
Gary Chan, MD
University of Utah


Backup Contact:

N/A


Location Contact:

Salt Lake City, Utah 84132
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.