Status:
TERMINATED
An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants
Lead Sponsor:
University of Calgary
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
Up to 4 years
Phase:
PHASE2
PHASE3
Brief Summary
A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular bleeding. Ind...
Detailed Description
This study is a randomized control trial.Those eligible infants will be randomized to either a Standard Dose group or to Escalating Dose indomethacin group after obtaining parental consent. The infant...
Eligibility Criteria
Inclusion
- Preterm infants with gestational age \< 29 weeks and/or birth weight \< 1251gm
- Presence of PDA after completion of first course of indomethacin
Exclusion
- Infants with PDA dependent congenital heart disease
- Chromosomal or major congenital anomalies
- Infants in whom use of indomethacin is contraindicated.(i.e.infants with acute renal failure,necrotizing enterocolitis,severe thrombocytopenia (platelet count \< 60,000/ mm3) and evidence of clinical bleeding (pulmonary bleeding, severe intraventricular bleeding grade 3\&4)
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00750581
Start Date
August 1 2008
End Date
January 1 2013
Last Update
August 18 2016
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9