Caffeine citrate

A medicine given to babies born early for apnoea of prematurity. In the CAP trial, caffeine given for this reason to very low birth weight babies lowered the share still needing oxygen at 36 weeks of postmenstrual age, which the trial authors call a lower rate of bronchopulmonary dysplasia.

Drug
In this atlas

Overview

Technical summary

Drug, level substance. RxCUI 20033 (RxNav name caffeine citrate, term type PIN, a precise ingredient) read 2026-10-15. The one claim on this page is a placebo-controlled trial in infants of 500 to 1250 g with short-term outcomes. It is a result for caffeine given for apnoea of prematurity, not a trial of caffeine to prevent BPD in infants without apnoea. No dose is recorded.

About this drug

Level: Substance
Mechanism: Not reported

Claims and evidence

Context Infants with birth weight 500 to 1250 g given caffeine or placebo in the first 10 days (CAP trial)

Recipient: Newborn
Population: 2006 infants with birth weights of 500 to 1250 g, randomly assigned during the first 10 days of life to caffeine or placebo until drug therapy for apnoea of prematurity was no longer needed. Supplemental oxygen at 36 weeks was counted among infants still alive at that postmenstrual age: 963 in the caffeine group and 954 in the placebo group. The registry lists the United States, Australia, Canada, Germany, Israel, the Netherlands, Sweden, Switzerland and the United Kingdom.
Care setting: Multicentre trial; the abstract names no setting
Geography: Nine countries listed by the registry (the abstract names none)
Life stage: Very low birth weight infants in the first 10 days of life; short-term outcomes before the first discharge home
Gestational age: Not reported
Postnatal age: Not reported
Follow-up: Short-term outcomes were evaluated before the first discharge home; the registry also lists outcomes at 18 months, 5 years and 11 to 12 years, which this record does not cover.

Eligibility: 1 inclusion criterion; exclusion criteria not stated

Included: Birth weight 500 to 1250 g, in the first 10 days of life
Excluded: None stated

Effect Interventional Certainty not assessed

In the CAP trial, 2006 infants with birth weights of 500 to 1250 g were randomly assigned during the first 10 days of life to caffeine or placebo until treatment for apnoea of prematurity was no longer needed. Among infants alive at a postmenstrual age of 36 weeks, 350 of 963 (36%) assigned to caffeine received supplemental oxygen, against 447 of 954 (47%) assigned to placebo (adjusted odds ratio 0.63; 95% CI 0.52 to 0.76; P<0.001). Positive airway pressure was stopped one week earlier with caffeine (median postmenstrual age 31.0 weeks against 32.0 weeks; P<0.001). Caffeine reduced weight gain temporarily (greatest after two weeks: mean difference -23 g; 95% CI -32 to -13; P<0.001). Rates of death, ultrasonographic signs of brain injury and necrotizing enterocolitis did not differ significantly between the groups. The authors conclude that caffeine therapy for apnoea of prematurity reduces the rate of bronchopulmonary dysplasia in infants with very low birth weight.
Applies to Newborn
- 2006 infants with birth weights of 500 to 1250 g, randomly assigned during the first 10 days of life to caffeine or placebo until drug therapy for apnoea of prematurity was no longer needed. Supplemental oxygen at 36 weeks was counted among infants still alive at that postmenstrual age: 963 in the caffeine group and 954 in the placebo group. The registry lists the United States, Australia, Canada, Germany, Israel, the Netherlands, Sweden, Switzerland and the United Kingdom.
- Multicentre trial; the abstract names no setting
- Nine countries listed by the registry (the abstract names none)
- Very low birth weight infants in the first 10 days of life; short-term outcomes before the first discharge home
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Short-term outcomes were evaluated before the first discharge home; the registry also lists outcomes at 18 months, 5 years and 11 to 12 years, which this record does not cover.
Certainty method
Not assessed

Limitations
Only the abstract was read. The result is for short-term outcomes before first discharge; the abstract reports the need for supplemental oxygen at 36 weeks, which the authors call bronchopulmonary dysplasia in their conclusion. Caffeine was given for apnoea of prematurity, so this is a finding about caffeine used for that reason (prevention of BPD in these infants), not about treating established BPD. Longer-term outcomes of the trial are not in this abstract and are not recorded.

Last checked
2026-10-15

Next evidence check due
Not scheduled
Sources and citations (2)
1. Supports Caffeine therapy for apnea of prematurity
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2006-05-18 · DOI: 10.1056/NEJMoa054065 · PMID: 16707748
  
  Locator
  Abstract, RESULTS sentences 1 to 5 and CONCLUSIONS sentence 1
  
  How it applies
  Oxygen need at 36 weeks, airway pressure, weight gain, other outcomes and the conclusion.
  
  Retrieved
  2026-10-15T13:49:24Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  257ddaadc90261743da0e865cb298a75f876be42ffac58f97a7ae522901b30f7
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
2. Background Caffeine therapy for apnea of prematurity
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2006-05-18 · DOI: 10.1056/NEJMoa054065 · PMID: 16707748
  
  Locator
  Abstract, BACKGROUND sentence 1 and METHODS
  
  How it applies
  Population, groups and follow-up.
  
  Retrieved
  2026-10-15T13:49:24Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  257ddaadc90261743da0e865cb298a75f876be42ffac58f97a7ae522901b30f7
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact CAP: caffeine given for apnoea of prematurity and the rate of BPD: Bronchopulmonary dysplasia (chronic lung disease of prematurity) (Evaluated for)
Applies to Newborn
- 2006 infants with birth weights of 500 to 1250 g, randomly assigned during the first 10 days of life to caffeine or placebo until drug therapy for apnoea of prematurity was no longer needed. Supplemental oxygen at 36 weeks was counted among infants still alive at that postmenstrual age: 963 in the caffeine group and 954 in the placebo group. The registry lists the United States, Australia, Canada, Germany, Israel, the Netherlands, Sweden, Switzerland and the United Kingdom.
- Multicentre trial; the abstract names no setting
- Nine countries listed by the registry (the abstract names none)
- Very low birth weight infants in the first 10 days of life; short-term outcomes before the first discharge home
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Short-term outcomes were evaluated before the first discharge home; the registry also lists outcomes at 18 months, 5 years and 11 to 12 years, which this record does not cover.
In the CAP trial, 2006 infants with birth weights of 500 to 1250 g were randomly assigned during the first 10 days of life to caffeine or placebo until treatment for apnoea of prematurity was no longer needed. Among infants alive at a postmenstrual age of 36 weeks, 350 of 963 (36%) assigned to caffeine received supplemental oxygen, against 447 of 954 (47%) assigned to placebo (adjusted odds ratio 0.63; 95% CI 0.52 to 0.76; P<0.001). Positive airway pressure was stopped one week earlier with caffeine (median postmenstrual age 31.0 weeks against 32.0 weeks; P<0.001). Caffeine reduced weight gain temporarily (greatest after two weeks: mean difference -23 g; 95% CI -32 to -13; P<0.001). Rates of death, ultrasonographic signs of brain injury and necrotizing enterocolitis did not differ significantly between the groups. The authors conclude that caffeine therapy for apnoea of prematurity reduces the rate of bronchopulmonary dysplasia in infants with very low birth weight.
Limitations. Only the abstract was read. The result is for short-term outcomes before first discharge; the abstract reports the need for supplemental oxygen at 36 weeks, which the authors call bronchopulmonary dysplasia in their conclusion. Caffeine was given for apnoea of prematurity, so this is a finding about caffeine used for that reason (prevention of BPD in these infants), not about treating established BPD. Longer-term outcomes of the trial are not in this abstract and are not recorded.

Record details

Record id: maternal:caffeine-citrate
Content hash: 72a31ff1a83910bead69508e6d68d0f7392b7e43ebd44f2b80140b6dd2b49d71