NCT05454332 The Caffeine Therapy in the Fetal to Neonatal Transition
| NCT ID | NCT05454332 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Mechanical Ventilation Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-04-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2022-04-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: The caffeine is used in the treatment for apnea of prematurity and it has several positive effects in the neurodevelopment of preterm babies. There are innumerable observational studies suggesting that initiating caffeine in the first hours of life may offer more benefits in the reduction of the necessity of intubation and in ventilation time. It is necessary to expand further research on the best time to start caffeine, which may improve the quality of care for premature infants. Objective: To evaluate the benefits of caffeine administration in the first two hours of life compared to administration at 24 hours of life in premature patients on noninvasive mechanical ventilation with birth weights less than 1250 grams. Methodology: Preterm newborn patients with birth weight \< 1250 grams born at Hospital de Clínicas de Porto Alegre who are not intubated in the delivery room will be included. Patients will be randomized into two groups. One arm of the study will receive caffeine at 2 hours of age and the other arm will receive caffeine at 24 hours of age (control). Patients in the control group will receive 0.9% SF at 2 hours of life in order to keep the study blinded. The following outcomes will be evaluated: need for intubation, time on invasive and non-invasive mechanical ventilation, BPD, necrotizing enterocolitis, need for ROP treatment, PDA with hemodynamic repercussions, peri-intraventricular hemorrhage, leukomalacia and death. The sample size calculation is 50 patients, 25 in each arm. Expected Results: It is expected to find a 43% reduction in the need for intubation in preterm infants who receive caffeine in the first two hours of life compared to administration at 24 hours of life. It is also expected to find a reduction in mechanical ventilation time, in addition to a possible reduction in negative outcomes associated with prematurity.
Eligibility Criteria
Inclusion Criteria: * Premature newborns with birth weight less than 1250 grams * Who are not intubated in the delivery room Exclusion Criteria: * Premature newborns from other hospitals * Presence of a major congenital malformation or genetic syndrome
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05454332 clinical trial?
This trial is open to participants of all sexes, up to 2 Hours, studying Mechanical Ventilation Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05454332 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05454332 currently recruiting?
Yes, NCT05454332 is actively recruiting participants. Contact the research team at gabs.trindade@gmail.com for enrollment information.
Where is the NCT05454332 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT05454332 clinical trial?
NCT05454332 is sponsored by Hospital de Clinicas de Porto Alegre. The trial plans to enroll 50 participants.