The Caffeine Therapy in the Fetal to Neonatal Transition

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Bronchopulmonary Dysplasia
Caffeine
Mechanical Ventilation Complication
Ventilator Lung; Newborn

Clinical Trial Details

NCT number	NCT05454332
Study type	Interventional
Source	Hospital de Clinicas de Porto Alegre
Contact	Gabriela Trindade
Phone	+55 51 985002009
Email	gabs.trindade@gmail.com
Status	Recruiting
Phase	Phase 4
Start date	April 27, 2022
Completion date	August 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.