Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
Primary Purpose
Patent Ductus Arteriosus, Prematurity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring premature infants, PDA, ibuprofen
Eligibility Criteria
Inclusion Criteria:
- Birth weight less than 1200gm
- Less than 28 weeks gestational age
- Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam
Exclusion Criteria:
- Active Bleeding
- Currently being treated for Persistent Pulmonary Hypertension (PPHN)
- Cardiac anomalies
- Chromosomal abnormalities
- Endocrine, metabolic, renal, or hepatic disorders
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Early treatment
Late treatment
Arm Description
Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration
Full Information
NCT ID
NCT00833365
First Posted
January 29, 2009
Last Updated
May 24, 2016
Sponsor
University of Utah
Collaborators
H. Lundbeck A/S
1. Study Identification
Unique Protocol Identification Number
NCT00833365
Brief Title
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
Official Title
Early vs. Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure and Pain/Stress Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Study drug not available
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus, Prematurity
Keywords
premature infants, PDA, ibuprofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early treatment
Arm Type
Active Comparator
Arm Description
Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Arm Title
Late treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
NeoProfen
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
NeoProfen
Intervention Description
Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg
Primary Outcome Measure Information:
Title
Number of PDA Closures Related to Treatment With Ibuprofen
Description
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.
Time Frame
Within 48 hrs of ibuprofen round
Secondary Outcome Measure Information:
Title
Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration
Time Frame
1 and 6 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
96 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Birth weight less than 1200gm
Less than 28 weeks gestational age
Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam
Exclusion Criteria:
Active Bleeding
Currently being treated for Persistent Pulmonary Hypertension (PPHN)
Cardiac anomalies
Chromosomal abnormalities
Endocrine, metabolic, renal, or hepatic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Chan, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
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