Caffeine for Apnea of Prematurity (CAP)

Completed · Phase 3

Conditions studied: Apnea of Prematurity

In brief

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. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity. Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.

Key facts

Study ID

NCT00182312

Run by

McMaster University

People needed

2000

Starts

1999-10-01

Expected to finish

2016-07-01

Last updated by the study team

2018-03-22

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• birthweight 500 to 1250 grams
• postnatal age day 1 to day 10
• infant considered a candidate for methylxanthine therapy by clinical staff

You may not qualify if…

• 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

Where it is running

• Brooklyn Hospital Center — Brooklyn, New York, United States
• Canberra Hospital — Canberra, Australian Capital Territory, Australia
• Women's & Children's Hospital — Adelaide, South Australia, Australia
• Mercy Hospital for Women — Melbourne, Victoria, Australia
• Royal Women's Hospital — Melbourne, Victoria, Australia
• Foothills Hospital — Calgary, Alberta, Canada
• Children's & Women's Health Centre of BC — Vancouver, British Columbia, Canada
• Victoria General Hospital — Victoria, British Columbia, Canada
• St. Boniface General Hospital — Winnipeg, Manitoba, Canada
• Moncton Hospital — Moncton, New Brunswick, Canada
• McMaster University — Hamilton, Ontario, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• Ottawa Hospital — Ottawa, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Sunnybrook & Women's College Health Science Centre — Toronto, Ontario, Canada
• Windsor Regional Hospital — Windsor, Ontario, Canada
• Royal Victoria Hospital — Montreal, Quebec, Canada
• University of Sherbrooke — Sherbrooke, Quebec, Canada
• Royal University Hospital — Saskatoon, Saskatchewan, Canada
• Centre Hospitalier Universitaire de Quebec — Québec, Canada
• Ludwig Maximilian University — Munich, Germany
• University of Tuebingen — Tübingen, Germany
• Soroka University Medical Center — Beersheba, Israel
• Meir General Hospital — Kfar Saba, Israel
• Kaplan Medical Center — Rehovot, Israel

Full record on ClinicalTrials.gov

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