Trial reportArchives of disease in childhood. Fetal and neonatal edition2004
High dose caffeine citrate for extubation of preterm infants: a randomised controlled trial.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
56 citing papers in PubMed, 5 syntheses or guidelines pooled it, 157 citations in OpenAlex.
- Caffeine for apnea and prevention of neurodevelopmental impairment in preterm infants: systematic review and meta-analysis.Journal of perinatology : official journal of the California Perinatal Association · 2024Pooled it
- Methylxanthine for the prevention and treatment of apnea in preterm infants.The Cochrane database of systematic reviews · 2023Pooled it
- Caffeine for the Treatment of Apnea in the Neonatal Intensive Care Unit: A Systematic Overview of Meta-Analyses.Paediatric drugs · 2020Pooled it
- Efficacy and Safety of Different Maintenance Doses of Caffeine Citrate for Treatment of Apnea in Premature Infants: A Systematic Review and Meta-Analysis.BioMed research international · 2018Pooled it
- Accounting for multiple births in neonatal and perinatal trials: systematic review and case study.The Journal of pediatrics · 2010Pooled it
- High versus standard dose caffeine in prevention of apnea of prematurity: an assessor-blinded randomized controlled trial (HI-CAF trial).European journal of pediatrics · 2026Trial
- Caffeine to prevent intermittent hypoxaemia in late preterm infants: randomised controlled dosage trial.Archives of disease in childhood. Fetal and neonatal edition · 2023Trial
- A Randomized Controlled Trial Comparing Two Doses of Caffeine for Apnoea in Prematurity.International journal of environmental research and public health · 2021Trial
- Trial
- [Comparison of the efficacy of domestic and imported caffeine citrate in the treatment of apnea in preterm infants: a prospective randomized double-blind controlled trial].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2020Trial
- [Clinical effect and safety of different maintenance doses of caffeine citrate in treatment of apnea in very low birth weight preterm infants: a prospective randomized controlled trial].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2019Trial
- A pilot randomized trial of high-dose caffeine therapy in preterm infants.Pediatric research · 2015Trial
- High versus low-dose caffeine for apnea of prematurity: a randomized controlled trial.European journal of pediatrics · 2015Trial
- NICU bedside caregivers sustain process improvement and decrease incidence of bronchopulmonary dysplasia in infants < 30 weeks gestation.Respiratory care · 2015Trial
- The effects of caffeine on heart rate variability in newborns with apnea of prematurity.Journal of perinatology : official journal of the California Perinatal Association · 2014Trial
- Effects of a divided high loading dose of caffeine on circulatory variables in preterm infants.Archives of disease in childhood. Fetal and neonatal edition · 2006Trial
- Discharging Preterm Infants on Caffeine-Practise Variation Across Europe: Results of a Cross-Sectional Survey.Acta paediatrica (Oslo, Norway : 1992) · 2026Article
- Putative mechanisms of caffeine as a neuroprotectant in preterm infants.Pediatric research · 2026Review
- Caffeine Therapy Reduces Severe Retinopathy of Prematurity in Neonates with Gestational Age between 23 and 28 Weeks.Ophthalmology science · 2026Article
- The Use of Caffeine Citrate in the Management of Neonatal Apnea in Low- and Middle-Income Countries: A Rapid Systematic Review.Health science reports · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare two dosing regimens for caffeine citrate in the periextubation period for neonates born at less than 30 weeks gestation in terms of successful extubation and adverse effects.
designA multicentre, randomised, double blind, clinical trial.
settingFour tertiary neonatal units within Australia. PATIENTS: Infants born less than 30 weeks gestation ventilated for more than 48 hours.
interventionsTwo dosing regimens of caffeine citrate (20 v 5 mg/kg/day) for periextubation management. Treatment started 24 hours before a planned extubation or within six hours of an unplanned extubation.
main outcome measureFailure to extubate within 48 hours of caffeine loading or reintubation and ventilation or doxapram within seven days of caffeine loading.
resultsA total of 234 neonates were enrolled. A significant reduction in failure to extubate was shown for the 20 mg/kg/day dosing group (15.0% v 29.8%; relative risk 0.51; 95% confidence interval (CI) 0.31 to 0.85; number needed to treat 7 (95% CI 4 to 24)). A significant difference in duration of mechanical ventilation was shown for infants of less than 28 weeks gestation receiving the high dose of caffeine (mean (SD) days 14.4 (11.1) v 22.1 (17.1); p = 0.01). No difference in adverse effects was detected in terms of mortality, major neonatal morbidity, death, or severe disability or general quotient at 12 months.
conclusionsThis trial shows short term benefits for a 20 mg/kg/day dosing regimen of caffeine citrate for neonates born at less than 30 weeks gestation in the periextubation period, without evidence of harm in the first year of life.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.