Caffeine for Apnea of Prematurity (CAP)

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); National Health and Medical Research Council, Australia
• Treatments: Caffeine; Caffeine citrate

Criteria

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