The Caffeine Therapy in the Fetal to Neonatal Transition
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorHospital de Clinicas de Porto Alegre
About this trial
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
This trial does not accept healthy volunteersQualifiers
Premature newborns with birth weight less than 1250 grams
Who are not intubated in the delivery room
Disqualifiers
Premature newborns from other hospitals
Presence of a major congenital malformation or genetic syndrome
Trial design
Design model
Parallel
Treatments tested in this trial
Early Caffeine administration
DrugBlinding will be done with the administration of saline solution. Patients in the early caffeine group will receive an attack dose of caffeine 20 mg/kg and begin maintenance dose 10 mg/kg/day. Patients in the late caffeine group, receive bolus of saline solution in the first 2 hours of life, starting, at 24 hours of life, the caffeine-loading dose 20 mg/kg and after maintenance dose 10mg/kg/day. The medical team will prescribe the medication, and the pharmacy will be responsible for randomly dispensing the caffeine or saline solution. The pharmacy will prepare syringes with the medication or saline solution identified by a code referring to the randomization without identifying which solution is being administered. The syringes will be sent to the neonatal ICU and will be administered according to the physician's prescription. The administration will be blinded.
Control Group
Other interventionBlinding will be done with the administration of saline solution. Patients in the early caffeine group will receive an attack dose of caffeine 20 mg/kg and begin maintenance dose 10 mg/kg/day. Patients in the late caffeine group, receive bolus of saline solution in the first 2 hours of life, starting, at 24 hours of life, the caffeine-loading dose 20 mg/kg and after maintenance dose 10mg/kg/day. The medical team will prescribe the medication, and the pharmacy will be responsible for randomly dispensing the caffeine or saline solution. The pharmacy will prepare syringes with the medication or saline solution identified by a code referring to the randomization without identifying which solution is being administered. The syringes will be sent to the neonatal ICU and will be administered according to the physician's prescription. The administration will be blinded.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Early Caffeine GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Necessity of intubation
Noninvasive ventilation failure will be defined as intubation in the first seven days of life with the need for invasive ventilation for at least 24 hours.
Time frame
first week of lifeSecondary outcomes
1
mechanical ventilation time
Mechanical ventilation time will be counted until first successful extubation (at least 24 hours extubated)
Time frame
until first successful extubation (followed up at least until 36 weeks of corrected age, discharge or death)2
Number of Participants with Bronchopulmonary dysplasia
Bronchopulmonary dysplasia will be defined as need for O2 or ventilatory support at 36 weeks corrected gestational age.
Time frame
followed up at least until 36 weeks of corrected age, discharge or death.3
Number of Participants with Intracranial hemorrhage
Intracranial hemorrhage will be defined as intracranial hemorrhage grade 3.
Time frame
followed up at least until 36 weeks of corrected age, discharge or death.4
Number of Participants with Retinopathy of prematurity
Retinopathy of prematurity will be defined with ROP requiring treatment.
Time frame
followed up at least until 36 weeks of corrected age, discharge or death.Sponsors and contacts
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Source ClinicalTrials.gov