Caffeine Citrate to Improve Neonatal Outcomes.

NCT06972849 | Not Yet Recruiting DMC

• 1 other identifier: P-N01-BabyCCINO
• Study Type: interventional
• Target: 3,900
• Locations: 0 countries
• Sites: N/A

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 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).

Conditions

Apnea of Prematurity

Keywords

Preterm infant; Apnea of Prematurity; Apnoea of Prematurity; Caffeine citrate

Outcome Measures

Primary Outcomes (1)

• Number of participants who progress by at least one level higher on the PLATIPUS Ordinal Outcome Scale

  The PLATIPUS-Ordinal Outcome Scale ranks the most severe core short-term infant health outcome in the specified time frame. Levels 1-15: 1= Well, liveborn infant; 2= Neonatal unit admission for \<48 hours; 3= Neonatal unit admission for \>/= 48 hours; 4= Non-invasive respiratory support or oxygen therapy for ≥ 4 hours \& \< 5 days; 5= Non-invasive respiratory support or oxygen therapy \>/= 5 days; 6= Mechanical ventilation via endotracheal tube for ≥ 4 hours \& \<7 days; 7= Mechanical ventilation via endotracheal tube for \>/=7 days; 8= Moderate respiratory morbidity; 9=Necrotising enterocolitis AND/OR Sepsis; 10= Severe Respiratory Morbidity; 11= Major Surgery; 12= Brain Injury; 13= TWO of severe respiratory morbidity OR major surgery OR brain injury; 14= Severe respiratory morbidity \& major surgery \& brain injury; 15 = Death.

  At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier)

Secondary Outcomes (8)

• Number of infants with moderate respiratory morbidity (as per the primary outcome)

  At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier).

• Number of infants with severe respiratory morbidity (as per the primary outcome)

  At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier).

• Duration of any positive pressure ventilation, in days

  From first date and time (any mode), to final date and time (any mode), up to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier)

• Duration of mechanical ventilation, in days

  From start date and time, to end date and time, up to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier)

• Number of infants with patent ductus arteriosus treated with medication or surgery

  At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier)

Other Outcomes (4)

• Core Secondary Outcome 1: Number of participants in each, individual component of the primary outcome.

  At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier)

• Core Secondary Outcome 2: Infant growth measures

  At 42 weeks postmenstrual age or first discharge home from hospital (whichever is earliest).

• Core Secondary Outcome 3: Total duration of first hospitalisation (birth admission)

  From date of birth to date first discharged home from hospital

Study Arms (3)

Caffeine citrate 40mg

ACTIVE COMPARATOR

Dose and frequency 40mg/kg load and 20mg/kg maintenance daily, as long as clinically indicated. Administration Loading dose: 2mL/kg loading dose of study drug, either IV or enterally, administered at \<72 hours of life, followed by Maintenance dose: 1mL/kg maintenance dose given daily, either IV or enterally, commenced 24 hours after loading dose.

Drug: Caffeine citrate

Caffeine citrate 30mg

ACTIVE COMPARATOR

Dose and frequency 30 mg/kg load and 15mg/kg maintenance daily, as long as clinically indicated. Administration Loading dose: 2mL/kg loading dose of study drug, either IV or enterally, administered at \<72 hours of life, followed by Maintenance dose: 1mL/kg maintenance dose given daily, either IV or enterally, commenced 24 hours after loading dose.

Drug: Caffeine citrate

Caffeine citrate 20mg

ACTIVE COMPARATOR

Dose and frequency 20mg/kg load and 10mg/kg maintenance daily, as long as clinically indicated. Administration Loading dose: 2mL/kg loading dose of study drug, either IV or enterally, administered at \<72 hours of life, followed by Maintenance dose: 1mL/kg maintenance dose given daily, either IV or enterally, commenced 24 hours after loading dose.

Drug: Caffeine citrate

Interventions

Caffeine citrate DRUG

Clinically indicated for apnea of prematurity.

Also known as: Cafcit

Caffeine citrate 20mg; Caffeine citrate 30mg; Caffeine citrate 40mg

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• (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.
• BabyCCINO-SPECIFIC ELIGIBILITY
• 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.
• 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

Sponsors & Collaborators

• University of Melbourne: lead

MeSH Terms

Conditions

Apnea; Premature Birth

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Brett Manley, MBChB PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brett Manley, MB BS, PhD

CONTACT

00610383452000; Brett.Manley@unimelb.edu.au

Kelly Fredell

CONTACT

info@platipustrial.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties will be blinded to the assigned intervention arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: BabyCCINO is a domain within the PLATIPUS adaptive platform trial (NCT06461429).

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2050
• Last Updated: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: This is estimated to be approximately six months following the completion of the two-year follow-up of domain participants.
• Access Criteria: To be determined. Access requests will be subject to review by trial subcommittees. The Trial Steering Committee will approve or disapprove requests. A Data Transfer Agreement and Authorship Agreement signed by relevant parties and evidence of ethical approval will be required.