The Caffeine Therapy in the Fetal to Neonatal Transition

Hospital de Clinicas de Porto Alegre

Status and phase: Enrolling; Phase 4

Conditions: Caffeine; Mechanical Ventilation Complication; Ventilator Lung; Newborn

Treatments: Other: Control Group; Drug: Early Caffeine administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05454332

2021-0463

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 2 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Early Caffeine Group

Experimental group

Description:

Group administering caffeine in the first 2 hours of life. Patients in the early caffeine group will receive an attack dose of caffeine 20 mg/kg and begin maintenance dose 10 mg/kg/day.

Treatment:

Drug: Early Caffeine administration

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Control Group