The Caffeine Therapy in the Fetal to Neonatal Transition
Status:
Recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
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.