Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. However, little is known about the long-term effects of methylxanthines on the developing brain.

The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the CAP trial.

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

Details

• Lead Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Caffeine; Caffeine citrate

Criteria

Inclusion Criteria:

• Males or females aged 5-7 years who are enrolled in the CAP trial.

• Parental/guardian permission (informed consent) and if appropriate, child assent.