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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00961753

Acronym

OIDS

Enrollment

Registered

2009-08-19

Start date

2009-08-31

Completion date

2010-10-31

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

Keywords

PDA, Ibuprofen, Preterm, Neonate

Brief 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.

Detailed 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.

Interventions

DRUGoptimized 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

DRUGStandard Ibuprofen

day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 29 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
PDA Closure	1-42 days of age

Secondary

Measure	Time frame
renal function	1-30 days of age

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026