Trial reportArchives of disease in childhood. Fetal and neonatal edition2026
Intermittent hypoxia and caffeine in infants born preterm: the ICAF Randomized Clinical Trial.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03321734 (Intermittent Hypoxia and Caffeine in Infants Born Preterm), which is not on this map. Cited by 2 papers.
What it found
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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.
Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF)
Who cites it
2 citing papers in PubMed.
- Early Versus Conventional Discontinuation of Caffeine Therapy for Apnea of Prematurity: A Randomized Controlled Trial-The DECaf Trial.Pediatric pulmonology · 2026Trial
- Motivations for and against Participation in Neonatal Research: Insights from Interviews of Diverse Parents Approached for Neonatal Research in the United States.The Journal of pediatrics · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
objectiveTo determine whether extending caffeine therapy through 43 weeks' postmenstrual age (PMA) decreases intermittent hypoxia (IH) in convalescing preterm infants. Secondary objectives were to assess caffeine effects on changes in inflammation-related plasma biomarkers and brain MRI.
designMulticentre masked randomised trial.
setting16 US hospitals. PATIENTS: Infants at <30 weeks + 6 days gestational age on caffeine between 32 weeks and 36+5 days PMA in room air with routine caffeine discontinuation prior to 36 weeks +6 days.
interventionRandomisation to caffeine or placebo and treated through 42 completed weeks. Pulse oximetry was recorded from enrolment through 1 week after stopping study drug. Blood for 12 inflammation-related biomarkers obtained at enrolment and 38 weeks' PMA and brain imaging after enrolment or <3 days of randomisation, and study end.
main outcome measureSeconds/hour of oxygen saturation <90% from randomisation to study end.
resultsRandomised 160 subjects, 78 placebo, 82 caffeine. IH was less at every PMA with caffeine treatment from 34 (172.7 (123.4, 241.7); 84.7 (64.4, 111.4, p<0.01) through 41 weeks (73.0 (51.3, 103.7); 26.6 (18.5, 38.2, p<0.001). Adjusted TNF-α levels were 23% lower at follow-up in the caffeine group compared with placebo (p<0.02), without other biomarker differences. Paired brain imaging found no significant differences.
conclusionsExtended caffeine reduced the burden of IH in very preterm infants and may reduce inflammation. Further study is needed to determine if this effect of caffeine is associated with reduced risk of adverse outcomes. TRIAL REGISTRATION NUMBER: NCT03321734.
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Registered trials
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