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Intermittent hypoxia and caffeine in infants born preterm: the ICAF Randomized Clinical Trial
Eric Eichenwald1, Michael Corwin2, Betty McEntire3
1Pediatrics/Neonatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA eichenwald@email.chop.edu.
Archives of Disease in Childhood. Fetal and Neonatal Edition
|November 24, 2025
Summary
Extending caffeine therapy for preterm infants through 43 weeks postmenstrual age significantly reduced intermittent hypoxia (IH). This intervention also showed a potential to lower inflammation markers, warranting further investigation for adverse outcome reduction.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Respiratory Physiology
Background:
- Preterm infants often experience intermittent hypoxia (IH) due to immature respiratory control.
- Caffeine is commonly used to treat apnea of prematurity, but its optimal duration is debated.
- Extended caffeine therapy may mitigate IH and associated complications in vulnerable preterm infants.
Purpose of the Study:
- To evaluate if extending caffeine therapy until 43 weeks postmenstrual age (PMA) reduces IH in convalescing preterm infants.
- To assess the impact of extended caffeine on inflammation biomarkers and brain MRI outcomes.
- To investigate the safety and efficacy of prolonged caffeine administration in this population.
Main Methods:
- A multicenter, masked, randomized controlled trial involving preterm infants (<30 weeks + 6 days gestational age).
- Infants received either caffeine or placebo from 32 weeks PMA through 42 completed weeks.
- Primary outcome was IH measured by seconds/hour of oxygen saturation <90%; secondary outcomes included plasma biomarkers and brain MRI.
Main Results:
- Caffeine treatment significantly reduced IH burden from 34 to 41 weeks PMA compared to placebo (p<0.01 to p<0.001).
- Adjusted TNF-α levels were 23% lower in the caffeine group at follow-up (p<0.02), with no significant changes in other biomarkers.
- No significant differences were observed in paired brain imaging between the groups.
Conclusions:
- Extended caffeine therapy through 43 weeks PMA effectively reduces IH in very preterm infants.
- The therapy may also exert anti-inflammatory effects, potentially influencing long-term outcomes.
- Further research is necessary to confirm if reduced IH and inflammation translate to improved clinical outcomes.
