Status:
WITHDRAWN
Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies
Lead Sponsor:
KK Women's and Children's Hospital
Collaborating Sponsors:
National University Hospital, Singapore
Cumberland Pharmaceuticals
Conditions:
Ductus Arteriosus, Patent
Very Low Birth Weight Infants
Eligibility:
All Genders
Up to 29 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature babies born und...
Detailed Description
According to Very Low Birth Weight (VLBW) High Risk Registration database in KKWCH, a hemodynamically significant patent ductus arteriosus (PDA) is a common problem in very premature infants born at a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Infants \<29 weeks gestation with a PDA diameter of \>= 1.5 mm on 2Dechocardiogram
- Parental written informed consent - Parent agrees to the subject's participation in the study as indicated by parent's signature on the consent form
- Parent is willing to comply with procedures/treatment and is able to keep to scheduled study assessments
- Exclusion criteria:
- Major congenital malformations in the opinion of the investigator
- Necrotising enterocolitis
- Gastrointestinal Perforation
- Systemic illness other than PDA, not fit for the trial in the opinion of the investigator
- The parent is in the opinion of the investigator, mentally or legally incapacitated
- The parent is unwilling/unable to comply to study procedures
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00470743
Start Date
May 1 2007
End Date
June 1 2009
Last Update
September 2 2015
Active Locations (1)
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1
KK Women's and Children's Hospital / National University Hospital
Singapore, Singapore, 229899