None listed
Conditions
Brief summary
Late preterm babies (34+0 to 36+6 weeks’ gestational age (GA)) are the most common of all preterm babies and have a 30% increased risk of severe long-term neurodevelopmental impairment compared to babies born at term. Caffeine citrate is effective at improving neurodevelopmental outcomes in very preterm babies (less than 32 weeks GA). Our hypothesis is that caffeine citrate administered to late preterm babies will reduce the risk of long-term neurodevelopmental impairment. The Latte trial will determine if caffeine citrate at a dose of 20 mg/kg every day from 3 days after birth to term equivalent age in late preterm babies improve neurodevelopmental outcomes at 2.5 years.
Interventions
Phase III trial
Caffeine citrate, as an oral cherry flavoured syrup, 20 mg/kg once daily from Day 3 after birth until term corrected age.
Dose can be reduced to 10 mg/kg if the baby is tachycardic (heart rate greater than 180 beats per min at rest 1 week after randomisation) or if the parents or clinicians believe the infant is having side effects.
Adherence will be assessed by a research nurse measuring the remaining syrup in the bottle after 3 weeks of intervention.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 72 Hours
Healthy volunteers
No
Inclusion criteria
Babies born between 34+0 and 36+6 weeks’ gestational age without contra-indication to caffeine treatment.
Exclusion criteria
Major congenital abnormality • Minor congenital abnormality likely to affect respiration, growth, or development • Previous caffeine treatment • Renal or hepatic impairment • Tachyarrhythmia • Seizures • Hypoxic ischaemic encephalopathy • Maternal age less than 16 years • More than 72 hours after birth • Multiple births of triplets or higher
Outcome results
None listed