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

NCT00833365 | Terminated Results

• 1 other identifier: 31394
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Patent Ductus Arteriosus; Prematurity

Keywords

premature infants; PDA; ibuprofen

Outcome Measures

Primary Outcomes (1)

• Number of PDA Closures Related to Treatment With Ibuprofen

  Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.

  Within 48 hrs of ibuprofen round

Secondary Outcomes (1)

• Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration

  1 and 6 hours

Study Arms (2)

Early treatment

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Late treatment

ACTIVE COMPARATOR

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

Interventions

Ibuprofen 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

Also known as: NeoProfen

Early treatment

Eligibility Criteria

• Age: Up to 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight less than 1200gm
• Less than 28 weeks gestational age
• Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

You may not qualify if:

• Active Bleeding
• Currently being treated for Persistent Pulmonary Hypertension (PPHN)
• Cardiac anomalies
• Chromosomal abnormalities
• Endocrine, metabolic, renal, or hepatic disorders

Sponsors & Collaborators

• University of Utah: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Gary Chan
• Organization: University of Utah

gary.chan@hsc.utah.edu

801-587-7508

Study Officials

• Gary Chan, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: February 2, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 4, 2016
• Results First Posted: July 4, 2016

Record last verified: 2014-12

Locations

US (1)