Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-28
SponsorQueen's University
About this trial
The goal of this pilot clinical trial is to test if it is possible to conduct a larger study on the use of caffeine in preterm infants who need help with their breathing. It will also look at whether caffeine helps these infants get healthy enough to leave the hospital sooner.
The main questions the researchers aim to answer are:
Can the investigators successfully recruit and keep enough participants in the study? Do the medical teams follow the study drug instructions correctly? Does caffeine reduce the total time infants spend in the Neonatal Intensive Care Unit (NICU)? Researchers will compare caffeine to a placebo (a look-alike substance with no active medicine) to see if caffeine is a helpful treatment for babies born between 28 and 34 weeks of gestation who are using a breathing machine or oxygen.
Participants will:
Be randomly assigned to receive either caffeine or a placebo through an IV or a feeding tube.
Receive the study treatment once a day as long as they require respiratory support (and for 24 hours after they stop).
Be monitored by the research team for clinical outcomes like feeding progress, breathing stability, and growth until they are discharged from the hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infant born at a gestational age between 28+0 and 34+6 weeks.
Admitted to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of life.
Requiring either invasive respiratory support (mechanical ventilation) or non-invasive respiratory support (e.g., CPAP, High Flow Nasal Cannula) within the first 72 hours of life.
Informed consent obtained from parent(s) or legal guardian(s).
Disqualifiers
Presence of dysmorphic features or major congenital malformations that adversely affect life expectancy.
Known or strongly suspected cyanotic heart disease.
Infants born at <28 weeks' gestational age (due to high risk of apnea requiring routine caffeine).
Late preterm infants born at ≥35+0 weeks' gestational age (due to short NICU stay not allowing for a safe caffeine-free period before discharge).
Trial design
Design model
Parallel
Treatments tested in this trial
Caffeine
DrugInfants randomized to this arm will receive caffeine citrate administered as a 10 mg/kg loading dose (caffeine base equivalent), followed by a 5 mg/kg daily maintenance dose (caffeine base equivalent).
Placebo
Other interventionInfants randomized to this arm will receive 0.9% normal saline administered in a volume equivalent to the caffeine citrate arm. The placebo will be administered as a loading dose followed by a daily maintenance dose matching the volume and timing of the experimental protocol
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Caffeine Citrate GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment/Eligibility Proportion
Ratio of enrolled/randomized infants to total eligible infants screened.
Time frame
Through study completion, up to 24 months2
Treatment Adherence Proportion
Percentage of per-protocol doses (caffeine/placebo) successfully administered
Time frame
From randomization until 24 hours after weaning from respiratory support3
Retention Proportion
Percentage of randomized infants who complete the study protocol until NICU discharge
Time frame
Through study completion, up to 24 monthsSecondary outcomes
1
Time to Discharge Alive from the NICU
Hours from the time of randomization to the time of discharge alive from the NICU
Time frame
From the date of randomization until the date of discharge alive from NICU, assessed up to 24 months2
Parent/Guardian Acceptability
Frequency distribution of Likert-scale responses on the parent satisfaction survey
Time frame
Within 7 days prior to infant's NICU discharge3
Healthcare Provider Acceptability
Thematic analysis of healthcare provider focus group transcripts regarding protocol viability
Time frame
Through recruitment completion, an average of 24 months4
Data Completeness
Proportion of missing data points across all secondary clinical outcomes.
Time frame
At the end of the recruitment period, approximately 24 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: