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(Rad 8)Caffeine prophylaxis to improve intermittent hypoxaemia in infants born late preterm: a randomised controlled
Elizabeth Anne Oliphant1,2, Christopher J D McKinlay3,4, David G McNamara5
1Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand e.oliphant@auckland.ac.nz.
Insights
This study investigates optimal caffeine citrate doses for late preterm infants experiencing intermittent hypoxemia. Findings will guide future trials on preventing hypoxemia in this vulnerable population.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Clinical Trials
Background:
- Late preterm infants (34-36 weeks' gestation) frequently experience intermittent hypoxemia.
- Caffeine citrate is known to improve outcomes in very preterm infants and may benefit late preterm infants.
Purpose of the Study:
- To determine the most effective and best-tolerated dose of caffeine citrate for reducing intermittent hypoxemia in late preterm infants.
- To inform the design of larger clinical trials by identifying optimal dosing strategies.
Main Methods:
- A phase IIB, randomized controlled trial comparing four doses of caffeine citrate (5-20 mg/kg/day) against a placebo.
- Infants were monitored for intermittent hypoxemia via overnight oximetry, with assessments at baseline, 2 weeks, and corrected term age.
Main Results:
- Primary outcome: frequency of intermittent hypoxemia events per hour at 2 weeks post-randomization.
- Secondary outcomes: growth, feeding, and sleeping patterns assessed by parental report.
Conclusions:
- The trial aims to establish the optimal prophylactic dose of caffeine citrate for late preterm infants.
- Results will provide crucial data for future large-scale studies on caffeine's efficacy in this population.
Introduction:
Infants born late preterm (34+0 to 36+6 weeks' gestational age) have frequent episodes of intermittent hypoxaemia compared with term infants. Caffeine citrate reduces apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes in infants born very preterm and may have similar effects in late preterm infants. Clearance of caffeine citrate increases with gestational age and late preterm infants are likely to need a higher dose than very preterm infants. Our aim is to determine the most effective and best-tolerated dose of caffeine citrate to reduce transient intermittent hypoxaemia events in late preterm infants.
Methods And Analysis:
A phase IIB, double-blind, five-arm, parallel, randomised controlled trial to compare the effect of four doses of oral caffeine citrate versus placebo on the frequency of intermittent hypoxaemia. Late preterm infants will be enrolled within 72 hours of birth and randomised to receive 5, 10, 15 or 20 mg/kg/day caffeine citrate or matching placebo daily until term corrected age. The frequency of intermittent hypoxaemia (events/hour where oxygen saturation concentration is ≥10% below baseline for ≤2 min) will be assessed with overnight oximetry at baseline, 2 weeks after randomisation (primary outcome) and at term corrected age. Growth will be measured at these timepoints, and effects on feeding and sleeping will be assessed by parental report. Data will be analysed using generalised linear mixed models.
Ethics And Dissemination:
This trial has been approved by the Health and Disability Ethics Committees of New Zealand (reference 18/NTA/129) and the local institutional research review committees. Findings will be disseminated to peer-reviewed journals to clinicians and researchers at local and international conferences and to the public. The findings of the trial will inform the design of a large multicentre trial of prophylactic caffeine in late preterm infants, by indicating the most appropriate dose to use and providing information on feasibility.
Trial Registration Number:
ACTRN12618001745235; Pre-results.
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