Maternal & Newborn Atlas
About
Menu

Caffeine for Apnea of Prematurity (CAP) trial

A placebo-controlled trial in very low birth weight babies (500 to 1250 g) that compared caffeine with placebo, started in the first 10 days of life and given until treatment for apnoea of prematurity was no longer needed. Short-term results favoured caffeine for the need for oxygen at 36 weeks, with temporarily lower weight gain and no clear difference in death, brain injury on ultrasound or necrotizing enterocolitis.

  • Study
  • In this atlas

Overview

Design
Randomised, parallel-group, placebo-controlled trial of caffeine citrate injection in infants of 500 to 1250 g. Registry: allocation randomised, intervention model parallel, masking triple, primary purpose prevention.
Phase
Phase 3
Enrolled
  • 2,000 infants (registry estimated enrolment; ClinicalTrials.gov gives no unit) (planned count) (Caffeine for Apnea of Prematurity (CAP), retrieved )
  • 2,006 infants (randomized count) (Caffeine therapy for apnea of prematurity, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
Not reported
Started
(Caffeine for Apnea of Prematurity (CAP), retrieved )
Primary completion
(actual) (Caffeine for Apnea of Prematurity (CAP), retrieved )
Completion
(actual) (Caffeine for Apnea of Prematurity (CAP), retrieved )
Countries
United States, Australia, Canada, Germany, Israel, Netherlands, Sweden, Switzerland, United Kingdom (Caffeine for Apnea of Prematurity (CAP), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Registry NCT00182312 (phase 3, randomised, parallel, masking triple, status COMPLETED, lead sponsor McMaster University) and the 2006 paper (PubMed abstract only). The registry's enrolment of 2000 is an estimate; the abstract reports 2006 infants randomly assigned. The registry's primary outcome is the combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months, which this record does not report; its secondary outcomes include bronchopulmonary dysplasia. Later follow-up papers were not read.

Arms

  • Caffeine

    Intervention Caffeine citrate

    Caffeine until drug therapy for apnoea of prematurity was no longer needed (abstract); the registry names the intervention as caffeine citrate injection.

  • Placebo

    Intervention None named

    Matching placebo until drug therapy for apnoea of prematurity was no longer needed (abstract).

Findings

No findings are published for this study.

Record details

Record id
maternal:cap-trial
Content hash
b42f571bdc6eaa61df58b9985747c9ce425b199d35f577dfb847fd1320706b3a