Caffeine Citrate to Improve Neonatal Outcomes.

Launched by UNIVERSITY OF MELBOURNE · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Caffeine Citrate to Improve Neonatal Outcomes," is designed to find out the best dose of caffeine citrate for very preterm babies who experience apnea, which is when they briefly stop breathing. Researchers want to see how different doses of caffeine can help these fragile infants breathe more regularly and improve their overall health. The trial will compare three different doses of caffeine that are already used in hospitals to determine which one works best and is safest for these babies.

To take part in this study, babies must be born before 37 weeks of pregnancy and be less than 72 hours old. They need to be receiving care at a hospital participating in the trial. The babies will receive a larger initial dose of caffeine soon after birth, followed by a smaller daily dose as needed. It's important to note that only babies without certain serious health issues or those whose parents cannot provide consent will be excluded from the trial. This research aims to find the best way to help very preterm infants breathe better and thrive.

Gender

ALL

Eligibility criteria

• • PLATFORM ELIGIBILITY
• Participants must meet all core PLATIPUS platform inclusion criteria:
• • Born before 37 weeks gestation
• • Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and
• • Meet eligibility criteria for one or more platform domains.
• Participants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:
• • (Parent) Inability to consent for their infant, unless a domain-level waiver of consent is deemed appropriate.
• • Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening), including if neonatal intensive care is not being provided to the infant.
• • Infants who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for BabyCCINO-specific eligibility.
• • BabyCCINO-SPECIFIC ELIGIBILITY
• Platform-eligible participants must meet all BabyCCINO-specific inclusion criteria:
• • 1. Very preterm infants born \<32 weeks' gestation
• • 2. \<72 hours old
• 3. Very preterm infants born at \<32 weeks' gestation, \<72 hours of age, with any clinical indication for commencing caffeine, as determined by the treating clinician, including:
• • Prevention or treatment of apnoea
• • Facilitating extubation from mechanical ventilation
• • Prevention of BPD
• • For longer-term benefit.
• Participants will be excluded from participation if they meet any BabyCCINO-specific exclusion criteria:
• • 1. Prior treatment with caffeine, other methylxanthines, or doxapram
• • 2. Major congenital anomalies: major congenital cardiac disease (not including patent ductus arteriosus or isolated atrial/ventricular septal defects), major gastrointestinal malformations, congenital diaphragmatic hernia, known genetic syndromes, known brain malformations
• • 3. Death considered to be imminent in the next 24 hours, or intensive care not going to be offered or continued
• • 4. Pre-existing tachyarrhythmia (e.g., antenatal or postnatal supraventricular tachycardia)
• • 5. Pre-existing seizures
• • 6. No parental/caregiver consent or not satisfying the principles and criteria for waiver with consent to continue, as approved in the relevant jurisdiction
• • Platform-eligible participants who meet all BabyCCINO-specific inclusion criteria and none of the BabyCCINO-specific exclusion criteria will be eligible to participate in BabyCCINO.