LATTE Dosage Trial
This trial is investigating the most effective and best tolerated dose of caffeine to reduce intermittent hypoxaemiaia in late preterm infants.
Late preterm infants (babies born at 34+0 to 36+6 weeks’ gestational age) constitute 6% of all births or 3,700 annually in New Zealand. These infants have an increased risk of cerebral palsy, neurodevelopmental impairment and learning problems compared to babies born at term. Intermittent hypoxaemia (recurrent drops in oxygen saturation) is common in late preterm infants and may contribute to impaired brain development. Caffeine therapy may help to prevent intermittent hypoxaemia and improve neurodevelopmental outcomes.
What is the study trying to find out?
The LATTE Dosage trial is comparing which of 4 different doses of caffeine citrate, compared with placebo, is most effective and best tolerated fore reducing intermittent hypoxaemia.
Who can take part?
Babies born at 34+0 to 36+6 weeks’ gestational age at Auckland City or Middlemore Hospitals can take part.
What does the study involve?
Eligible babies will be randomly allocated within 72 hours of birth to either caffeine citrate 5 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg or placebo and continued until term equivalent age (40 weeks’ gestation). Overnight oximetry will be recorded before starting the trial medication; at two weeks after randomisation, and at the baby’s original due date. This may be in the hospital or birthing unit, or at home. Parents are asked to complete questionnaires about baby’s feeding and sleeping patterns and maternal health, wellbeing and caffeine intake. Saliva samples are collected from mum and baby at two weeks of age to allow investigation of how maternal caffeine intake impacts on the baby’s caffeine levels.
Are there any risks of taking part in the study?
Caffeine is very safe and well tolerated in very preterm babies. Late preterm babies may need a higher dose of caffeine due to their faster metabolism. This could be associated with side effects such as reflux, tachycardia (faster heart rate) or sleeping difficulties.
How can I find out more?
For more information, email the Latte Dosage Trial Team at email@example.com