# Caffeine for Apnea of Prematurity (CAP) trial

Study · id `maternal:cap-trial` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (public)

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Browse, life stage: Newborn; Infant follow-up  
Browse, care area: Preterm and sick newborns  

## In plain language

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.

## 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.

## Key facts

- 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: 2000 infants (registry estimated enrolment; ClinicalTrials.gov gives no unit) (planned count; Caffeine for Apnea of Prematurity (CAP), snapshot `maternal:ctgov-nct00182312-2026-10-15`, retrieved 2026-10-15); 2006 infants (randomized count; Caffeine therapy for apnea of prematurity, snapshot `maternal:pubmed-16707748-2026-10-15`, retrieved 2026-10-15)
- Started: 1999-10 (Caffeine for Apnea of Prematurity (CAP), snapshot `maternal:ctgov-nct00182312-2026-10-15`, retrieved 2026-10-15)
- Primary completion: 2007-03 (actual) (Caffeine for Apnea of Prematurity (CAP), snapshot `maternal:ctgov-nct00182312-2026-10-15`, retrieved 2026-10-15)
- Completion: 2016-07 (actual) (Caffeine for Apnea of Prematurity (CAP), snapshot `maternal:ctgov-nct00182312-2026-10-15`, retrieved 2026-10-15)
- Countries: United States; Australia; Canada; Germany; Israel; Netherlands; Sweden; Switzerland; United Kingdom (Caffeine for Apnea of Prematurity (CAP), snapshot `maternal:ctgov-nct00182312-2026-10-15`, retrieved 2026-10-15)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `maternal:ctgov-nct00182312-2026-10-15`, retrieved 2026-10-15)

## Connected pages

- Tests caffeine citrate injection: Caffeine citrate (`maternal:caffeine-citrate`)

## Provenance

Content hash: b42f571bdc6eaa61df58b9985747c9ce425b199d35f577dfb847fd1320706b3a
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15