Status:
NOT_YET_RECRUITING
Caffeine Citrate to Improve Neonatal Outcomes.
Lead Sponsor:
University of Melbourne
Conditions:
Apnea of Prematurity
Eligibility:
All Genders
Up to 32 years
Phase:
NA
Brief Summary
The goal of this clinical trial to learn what dose/s of caffeine citrate works to treat preterm born babies who have episodes where they stop breathing. It will also learn about the safety of differen...
Detailed Description
The BabyCCINO trial will compare the efficacy and safety of a higher, medium or lower-dose caffeine regimen in very preterm infants. It is a neonatal domain within the PLATIPUS adaptive platform trial...
Eligibility Criteria
Inclusion
- 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:
- Very preterm infants born \<32 weeks' gestation
- \<72 hours old
- 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:
- Prior treatment with caffeine, other methylxanthines, or doxapram
- 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
- Death considered to be imminent in the next 24 hours, or intensive care not going to be offered or continued
- Pre-existing tachyarrhythmia (e.g., antenatal or postnatal supraventricular tachycardia)
- Pre-existing seizures
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2050
Estimated Enrollment :
3900 Patients enrolled
Trial Details
Trial ID
NCT06972849
Start Date
October 1 2025
End Date
December 1 2050
Last Update
May 15 2025
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