Caffeine for Apnea of Prematurity (CAP)

Phase 3

Completed

• Conditions: Apnea of Prematurity

• Registration Number: NCT00182312
• Lead Sponsor: McMaster University

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2007-03
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months.	corrected age of 18 months

Secondary Outcome Measures

Name	Time	Method
bronchopulmonary dysplasia	discharge home
necrotizing enterocolitis	discharge home
brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly	discharge home
retinopathy of prematurity	discharge home
growth failure	corrected age of 18 months
functional status at 5 years and at 11-12 years	corrected age of 5 years and chronological age of 11-12 years

Trial Locations

Locations (34)

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands

University Hospitals of Geneve; 🇨🇭 Geneva, Switzerland

University of Zurich; 🇨🇭 Zurich, Switzerland

Sunnybrook & Women's College Health Science Centre; 🇨🇦 Toronto, Ontario, Canada

Mercy Hospital for Women; 🇦🇺 Melbourne, Victoria, Australia

Moncton Hospital; 🇨🇦 Moncton, New Brunswick, Canada

Windsor Regional Hospital; 🇨🇦 Windsor, Ontario, Canada

University of Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

University of Tuebingen; 🇩🇪 Tuebingen, Germany

Ludwig Maximilian University; 🇩🇪 Munich, Germany

Meir General Hospital; 🇮🇱 Kfar-Saba, Israel

Children's & Women's Health Centre of BC; 🇨🇦 Vancouver, British Columbia, Canada

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Victoria General Hospital; 🇨🇦 Victoria, British Columbia, Canada

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Royal Women's Hospital; 🇦🇺 Melbourne, Victoria, Australia

Canberra Hospital; 🇦🇺 Canberra, Australian Capital Territory, Australia

Brooklyn Hospital Center; 🇺🇸 Brooklyn, New York, United States

Women's & Children's Hospital; 🇦🇺 Adelaide, South Australia, Australia

Foothills Hospital; 🇨🇦 Calgary, Alberta, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Royal Victoria Infirmary; 🇬🇧 Newcastle-upon-Tyne, United Kingdom

Centre Hospitalier Universitaire de Quebec; 🇨🇦 Quebec, Canada

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel

University Children's Hospital Basel; 🇨🇭 Basel, Switzerland

Royal Maternity Hospital; 🇬🇧 Belfast, Northern Ireland, United Kingdom

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Astrid Lindgren's Children's Hospital; 🇸🇪 Stockholm, Sweden

South Cleveland Hospital; 🇬🇧 Middlesbrough, United Kingdom