The Caffeine Therapy in the Fetal to Neonatal Transition

Phase 4

Recruiting

• Conditions: Mechanical Ventilation Complication; Caffeine; Ventilator Lung; Newborn
• Interventions: Other: Control Group; Drug: Early Caffeine administration

• Registration Number: NCT05454332
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-27
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Status Verified: 2024-05
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	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.
Early Caffeine Group	Early Caffeine administration	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.

Primary Outcome Measures

Name	Time	Method
Necessity of intubation	first week of life	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Intracranial hemorrhage	followed up at least until 36 weeks of corrected age, discharge or death.	Intracranial hemorrhage will be defined as intracranial hemorrhage grade 3.
mechanical ventilation time	until first successful extubation (followed up at least until 36 weeks of corrected age, discharge or death)	Mechanical ventilation time will be counted until first successful extubation (at least 24 hours extubated)
Number of Participants with Bronchopulmonary dysplasia	followed up at least until 36 weeks of corrected age, discharge or death.	Bronchopulmonary dysplasia will be defined as need for O2 or ventilatory support at 36 weeks corrected gestational age.
Number of Participants with Retinopathy of prematurity	followed up at least until 36 weeks of corrected age, discharge or death.	Retinopathy of prematurity will be defined with ROP requiring treatment.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil