Clinical trial NCT05454332: The Caffeine Therapy in the Fetal to Neonatal Transition
Official title: The Caffeine Therapy in the Fetal to Neonatal Transition in Preterms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Mechanical Ventilation Complication
Caffeine
Ventilator Lung; Newborn
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 50
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Necessity of intubation
timeFrame: first week of life
Secondary outcomes:
measure: mechanical ventilation time
timeFrame: until first successful extubation (followed up at least until 36 weeks of corrected age, discharge or death)
measure: Number of Participants with Bronchopulmonary dysplasia
timeFrame: followed up at least until 36 weeks of corrected age, discharge or death.
measure: Number of Participants with Intracranial hemorrhage
timeFrame: followed up at least until 36 weeks of corrected age, discharge or death.
measure: Number of Participants with Retinopathy of prematurity
timeFrame: followed up at least until 36 weeks of corrected age, discharge or death.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References: