Early Versus Late Use of Ibuprofen for PDA Closure

This study has been terminated.

(Study drug not available)

Sponsor:

Collaborator:

H. Lundbeck A/S

Information provided by:

University of Utah

ClinicalTrials.gov Identifier:

NCT00833365

First received: January 29, 2009

Last updated: November 23, 2011

Last verified: November 2011

History of Changes

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.

Condition	Intervention
Patent Ductus Arteriosus Prematurity	Drug: Ibuprofen

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Early vs. Late Use of Ibuprofen for PDA Closure and Pain/Stress Reduction

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysinate

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

The primary objective is to evaluate the PDA closure rate of early vs. late use of Ibuprofen (Ibu). [ Time Frame: Within 48 hrs of ibuprofen round ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 1 hr prior to initial dose, and then 1 and 6 hrs post initial dose of ibuprofen ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	January 2009
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Early treatment Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old	Drug: 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 Other Name: NeoProfen
Active Comparator: 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.	Drug: Ibuprofen Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg Other Name: NeoProfen

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

Ages Eligible for Study:	up to 96 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833365

Locations

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

Sponsors and Collaborators

University of Utah

H. Lundbeck A/S

Investigators

Principal Investigator:

Gary Chan, MD

University of Utah

More Information

No publications provided

Responsible Party:	Dr. Gary Chan, University of Utah
ClinicalTrials.gov Identifier:	NCT00833365 History of Changes
Other Study ID Numbers:	31394
Study First Received:	January 29, 2009
Last Updated:	November 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

premature infants
PDA
ibuprofen

Additional relevant MeSH terms:

Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013

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