%0 Journal Article %A Elizabeth Anne Oliphant %A Christopher JD McKinlay %A David McNamara %A Alana Cavadino %A Jane M Alsweiler %T Caffeine to prevent intermittent hypoxaemia in late preterm infants: randomised controlled dosage trial %D 2022 %R 10.1136/archdischild-2022-324010 %J Archives of Disease in Childhood - Fetal and Neonatal Edition %P fetalneonatal-2022-324010 %X Objective To establish the most effective and best tolerated dose of caffeine citrate for the prevention of intermittent hypoxaemia (IH) in late preterm infants.Design Phase IIB, double-blind, five-arm, parallel, randomised controlled trial.Setting Neonatal units and postnatal wards of two tertiary maternity hospitals in New Zealand.Participants Late preterm infants born at 34+0–36+6 weeks’ gestation, recruited within 72 hours of birth.Intervention Infants were randomly assigned to receive a loading dose (10, 20, 30 or 40 mg/kg) followed by 5, 10, 15 or 20 mg/kg/day equivolume enteral caffeine citrate or placebo daily until term corrected age.Primary outcome IH (events/hour with oxygen saturation concentration ≥10% below baseline for ≤2 min), 2 weeks postrandomisation.Results 132 infants with mean (SD) birth weight 2561 (481) g and gestational age 35.7 (0.8) weeks were randomised (24–28 per group). Caffeine reduced the rate of IH at 2 weeks postrandomisation (geometric mean (GM): 4.6, 4.6, 2.0, 3.8 and 1.7 events/hour for placebo, 5, 10, 15 and 20 mg/kg/day, respectively), with differences statistically significant for 10 mg/kg/day (GM ratio (95% CI] 0.39 (0.20 to 0.76]; p=0.006) and 20 mg/kg/day (GM ratio (95% CI] 0.33 (0.17 to 0.68]; p=0.003) compared with placebo. The 20 mg/kg/day dose increased mean (SD) pulse oximetry oxygen saturation (SpO2) (97.2 (1.0) vs placebo 96.0 (0.8); p<0.001), and reduced median (IQR) percentage of time SpO2 <90% (0.5 (0.2–0.8) vs 1.1 (0.6–2.4); p<0.001) at 2 weeks, without significant adverse effects on growth velocity or sleeping.Conclusion Caffeine reduces IH in late preterm infants at 2 weeks of age, with 20 mg/kg/day being the most effective dose.Trial registration number ACTRN12618001745235.Data are available on reasonable request. Published data are available to approved researchers under the data sharing arrangements provided by the Clinical Data Research Hub (CDRH), based at the Liggins Institute, University of Auckland (https://wiki.auckland.ac.nz/researchhub). Data access requests are to be submitted to the Data Access Committee via researchhub@auckland.ac.nz. Deidentified published data will be shared with researchers who provide a methodologically sound proposal and have appropriate ethical and institutional approval. Researchers must sign and adhere to the Data Access Agreement that includes a commitment to using the data only for the specified proposal, to refrain from any attempt to identify individual participants, to store data securely and to destroy or return the data after completion of the project. The CDRH reserves the right to charge a fee to cover the costs of making data available, if required. %U https://fn.bmj.com/content/fetalneonatal/early/2022/08/29/archdischild-2022-324010.full.pdf