The Caffeine Therapy in the Fetal to Neonatal Transition

PHASE4RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 27, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

August 30, 2026

Conditions
Mechanical Ventilation ComplicationCaffeineVentilator Lung; Newborn
Interventions
DRUG

Early Caffeine administration

Blinding 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.

OTHER

Control Group

Blinding 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.

Trial Locations (1)

90035-903

RECRUITING

Hospital de Clínicas de Porto Alegre, Porto Alegre

All Listed Sponsors
lead

Hospital de Clinicas de Porto Alegre

OTHER