Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates

Patent Ductus Arteriosus Clinical Trial

— OIDS  

Official title:

Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00961753
• Other study ID #: Ibuprofendosingstudy
• Status: Terminated
• Phase: Phase 4
• First received: August 18, 2009
• Last updated: January 25, 2014
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: January 2014
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.

Description:

Failure to close the PDA in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. The PDA often fails to close using currently approved Ibuprofen dosing regimens, and surgical closure becomes necessary. Ibuprofen clearance in premature neonates is significantly correlated with postnatal age, increasing rapidly over time. Hirt et al. published and optimized dosing scheme for preterm neonates based on pharmacokinetic and pharmacodynamic data. We aim to use this dosing regimen in the clinical setting to determine if increased rates of pharmacologic PDA closure can be achieved.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 29 Days

Eligibility

Inclusion Criteria:

• All neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of PDA diagnosis requiring nasal CPAP or mechanical ventilation

• Echo confirmed PDA with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt

• Signed informed consent

Exclusion Criteria:

• Presence of: ductal-dependent congenital heart disease, pulmonary hypertension,

• Active bleeding (including Grade 3 or 4 IVH)

• Platelet count < 100,000

• Coagulopathy

• Suspected NEC

• Suspected perforation

• Creatinine > 1.5

• Hyperbilirubinemia requiring exchange transfusion

• Hypotension requiring pressor support

• Life-threatening congenital malformation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• optimized ibuprofen
day of life 0-3 - 10, 5, 5 mg/kg/dose at 24 hour intervals day of life 4-6 - 14, 7, 7 mg/kg/dose at 24 hour intervals day of life 7-29 - 20, 10, 10 mg/kg/dose at 24 hour intervals
• Standard Ibuprofen
day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals

Locations

Country	Name	City	State
United States	Children's Hospital of Illinois at OSF Saint Francis Medical Center	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDA Closure		1-42 days of age	No
Secondary	renal function		1-30 days of age	Yes