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NOT YET RECRUITING

NCT06972849

Caffeine Citrate to Improve Neonatal Outcomes.

Sponsor: University of Melbourne

View on ClinicalTrials.gov

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 different doses of caffeine citrate for the variety of preterm-born babies that are prescribed this. The main question it aims to answer is: Which dose is the optimal dose of caffeine citrate for very preterm babies to prevent short-term death and disease? Researchers will compare three different doses of caffeine citrate, which are already used in clinical practice to treat breathing stoppages in preterm babies, to see which dose works best. No placebo will be used. Participants will be given a 'loading' dose of caffeine citrate \<72 hours of life, and a smaller 'maintenance' dose once a day, for as long as the baby needs this. This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).

Official title: BabyCCINO: Caffeine Citrate to Improve Neonatal Outcomes. A Neonatal Domain Within PLATIPUS.

Key Details

Gender

All

Age Range

Any - 32 Weeks

Study Type

INTERVENTIONAL

Enrollment

3900

Start Date

2025-10

Completion Date

2050-12

Last Updated

2025-05-15

Healthy Volunteers

Conditions

Apnea of Prematurity

Interventions

DRUG

Caffeine citrate

Clinically indicated for apnea of prematurity.

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.