Oliphant 2020.

Study name	Caffeine prophylaxis to improve intermittent hypoxemia in infants born late preterm: a randomized controlled dosage trial (Latte Dosage Trial)
Methods	Phase: IIB Study type: controlled trial Allocation: randomized Intervention model: parallel assignment, five‐arms Intervention model description: late preterm infants admitted to the neonatal unit and postnatal wards at Auckland City and Middlemore Hospitals (Auckland, New Zealand), randomized into five groups within 72 hours of birth to receive 5 mg/kg, 10 mg/kg, 15 mg/kg, or 20 mg/kg/day caffeine citrate or matching placebo daily until term corrected Masking: double‐blind Primary purpose: prevention
Participants	Infants born between 34 weeks and 36 weeks’ and 6 days gestation without contradiction to caffeine treatment. Sample size: 120.
Interventions	Enteral loading dose of the study drug (10 mg/kg, 20 mg/kg, 30 mg/kg, or 40 mg/kg of caffeine citrate or water), followed by a daily dose each morning (5 mg/kg, 10 mg/kg, 15 mg/kg, or 20 mg/kg of caffeine citrate or placebo) until term equivalent age (40 weeks’ post‐menstrual age)
Outcomes	Primary outcome: frequency of intermittent hypoxemia (events/hour) Secondary outcomes:  respiratory: frequency of intermittent hypoxemia on overnight oximetry at term equivalent age; mean overnight oxygen saturation at 2 weeks and term equivalent age; use of respiratory support, including oxygen, until term equivalent age; growth: growth velocity from birth to term equivalent age for weight gain, length and head circumference; failure to regain birth weight by 2 weeks of age; side effects: feed intolerance as reported by parents; duration of tube feeding; sleep and arousal as reported by parents (measured by sub scale nine on the Infant Behaviour Questionnaire‐Revised, modified for neonates); tachycardia; study drug stopped due to presumed side effects; neonatal seizures requiring anticonvulsant treatment before 44 weeks' postmenstrual age; neonatal or infant death; maternal and infant salivary caffeine concentration at two weeks after randomization; readmission to hospital until 44 weeks' postmenstrual age or open‐label caffeine use; and maternal caffeine intake at birth, 2 weeks and term corrected age and mental health (Edinburgh post‐natal depression score) at birth and term corrected age.
Starting date	Unknown
Contact information	Elizabeth Anne Oliphant: e.oliphant@auckland.ac.nz
Notes

AOP: apnea of prematurity; CPAP: continuous positive airway pressure; kg: kilogram; mg: milligram