Status:
COMPLETED
Caffeine for Apnea of Prematurity (CAP)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Conditions:
Apnea of Prematurity
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE3
Brief Summary
At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities....
Eligibility Criteria
Inclusion
- birthweight 500 to 1250 grams
- postnatal age day 1 to day 10
- infant considered a candidate for methylxanthine therapy by clinical staff
Exclusion
- dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
- unlikely to comply with long-term follow-up
- prior treatment with a methylxanthine
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00182312
Start Date
October 1 1999
End Date
July 1 2016
Last Update
March 22 2018
Active Locations (34)
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1
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
2
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
3
Women's & Children's Hospital
Adelaide, South Australia, Australia, 5006
4
Mercy Hospital for Women
Melbourne, Victoria, Australia, 3002