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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00833365
• Other study ID #: 31394
• Status: Terminated
• Phase: N/A
• First received: January 29, 2009
• Last updated: December 10, 2014
• Start date: January 2009
• Est. completion date: November 2011

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 96 Hours

Eligibility

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

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

Intervention

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
• Ibuprofen
Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to evaluate the PDA closure rate of early vs. late use of Ibuprofen (Ibu).		Within 48 hrs of ibuprofen round	No
Secondary	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.		1 hr prior to initial dose, and then 1 and 6 hrs post initial dose of ibuprofen	No