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Study identifier: NCT05454332 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

The Caffeine Therapy in the Fetal to Neonatal Transition

Condition: Mechanical Ventilation Complication · Caffeine · Ventilator Lung; Newborn  ·  Sponsor: Hospital de Clinicas de Porto Alegre

PhasePhase 4
Planned participants50
Who can joinAll sexes, N/A to 2 Hours
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Gabriela Trindade  ·  +55 51 985002009  ·  gabs.trindade@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital de Clínicas de Porto AlegrePorto Alegre, Rio Grande do Sul, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT05454332