Status:
TERMINATED
Timing of PDA Closure and Respiratory Outcome in Premature Infants
Lead Sponsor:
University of Miami
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
1-14 years
Phase:
NA
Brief Summary
The investigators propose the present study with the following aims: * to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen treatment at the onset of clinical symptoms i...
Detailed Description
Study terminated when intravenous (IV) ibuprofen withdrawn for both clinical and research use.
Eligibility Criteria
Inclusion
- Inborn patients at JHS hospitals (admitted to the NICU at JMH within the first 72 hrs of age
- BW 500-1250 grams
- 23-32 wks gestational age
- \> 1d but \< 14d of age.
Exclusion
- Major congenital malformations
- Proven sepsis (positive blood culture)
- Contraindications to the use of Ibuprofen or Indomethacin
- Terminal condition, not expected to survive beyond 48 h
- Infants born excessively SGA(3 S.D. below the mean for GA)
- Infants with initial PDA presentation that is hemodynamically significant
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00802685
Start Date
November 1 2007
End Date
February 1 2011
Last Update
February 5 2014
Active Locations (1)
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1
Jackson Memorial Hospital/Holtz Children's Center
Miami, Florida, United States, 33136