The Caffeine Therapy in the Fetal to Neonatal Transition

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.

Conditions

• Mechanical Ventilation Complication
• Caffeine
• Ventilator 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

2 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-27

Primary Completion

2025-12-31

Completion

2026-08-30

Countries

• Brazil

Study Locations