Caffeine Citrate to Improve Neonatal Outcomes.
ConditionApnea of Prematurity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 32
SponsorUniversity of Melbourne
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
(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.
Very preterm infants born <32 weeks' gestation
<72 hours old
Trial design
Design model
Parallel
Treatments tested in this trial
Caffeine citrate
DrugClinically indicated for apnea of prematurity.
Treatment groups
3,900 Participants
are divided into 3 treatment groupsGroup A: Caffeine citrate 40mgActive comparator 1 intervention
Group B: Caffeine citrate 30mgActive comparator 1 intervention
Group C: Caffeine citrate 20mgActive comparator 1 intervention
Trial outcomes
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.
Time frame
At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier)Secondary outcomes
1
Number of infants with moderate respiratory morbidity (as per the primary outcome)
Number of infants meeting the PLATIPUS-Ordinal Outcome Scale definition of 'moderate respiratory morbidity'.
Time frame
At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier).2
Number of infants with severe respiratory morbidity (as per the primary outcome)
Number of infants meeting the PLATIPUS-Ordinal Outcome Scale definition of 'severe respiratory morbidity'.
Time frame
At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier).3
Duration of any positive pressure ventilation, in days
Any positive pressure ventilation (mechanical ventilation, non-invasive positive pressure ventilation, continuous positive airway pressure or nasal high-flow therapy), in days (in survivors to 42 weeks' PMA or first discharge home from hospital, whichever is sooner).
Time frame
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)4
Duration of mechanical ventilation, in days
Mechanical ventilation, in days (in survivors to 42 weeks' PMA or first discharge home from hospital, whichever is sooner).
Time frame
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)Other outcomes
1
Core Secondary Outcome 1: Number of participants in each, individual component of the primary outcome.
The PLATIPUS-Ordinal Outcome Scale (primary outcome) 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.
Time frame
At any time prior to 42 weeks' postmenstrual age or first discharge home from hospital (whichever is earlier)2
Core Secondary Outcome 2: Infant growth measures
Head circumference (measured in cms), weight (measured in gms), length (measured in cms) and growth z-score will be calculated at 42 weeks postmenstrual age, or first discharge home from hospital (whichever is earliest)
Time frame
At 42 weeks postmenstrual age or first discharge home from hospital (whichever is earliest).3
Core Secondary Outcome 3: Total duration of first hospitalisation (birth admission)
Duration of first hospitalisation, measured in days.
Time frame
From date of birth to date first discharged home from hospital4
Core Secondary Outcome 4: Rate of (any) breastmilk feeding at 42 weeks postmenstrual age, or on the day of first discharge home from hospital.
Any breastmilk feeding (any mode - breast, bottle or tube) at 42 weeks postmenstrual age, or on the day of first discharge home from hospital.
Time frame
On the day of 42+0 weeks postmenstrual age or first discharge home from hospital (whichever is earliest)Locations
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Source ClinicalTrials.gov
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