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

Primary Purpose

Patent Ductus Arteriosus

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

optimized ibuprofen

Standard Ibuprofen

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring PDA, Ibuprofen, Preterm, Neonate

Eligibility Criteria

1 Day - 29 Days (Child)All SexesDoes not accept 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

Sites / Locations

Children's Hospital of Illinois at OSF Saint Francis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Optimized Ibuprofen

Standard Ibuprofen

Arm Description

Outcomes

Primary Outcome Measures

PDA Closure

Secondary Outcome Measures

renal function

Full Information

NCT ID

NCT00961753

First Posted

August 18, 2009

Last Updated

January 25, 2014

Sponsor

OSF Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT00961753

Brief Title

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

Acronym

OIDS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

FDA drug recall on July 30, 2010

Study Start Date

August 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OSF Healthcare System

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patent Ductus Arteriosus

Keywords

PDA, Ibuprofen, Preterm, Neonate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Optimized Ibuprofen

Arm Type

Experimental

Arm Title

Standard Ibuprofen

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

optimized ibuprofen

Other Intervention Name(s)

neoprofen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Standard Ibuprofen

Other Intervention Name(s)

neoprofen

Intervention Description

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

Primary Outcome Measure Information:

Title

PDA Closure

Time Frame

1-42 days of age

Secondary Outcome Measure Information:

Title

renal function

Time Frame

1-30 days of age

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

29 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James R Hocker, MD

Organizational Affiliation

OSF Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Illinois at OSF Saint Francis Medical Center

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61637

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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