Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05454332

The Caffeine Therapy in the Fetal to Neonatal Transition

Mechanical Ventilation Complication Clinical Trial

Official title:
The Caffeine Therapy in the Fetal to Neonatal Transition in Preterms

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

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 December 30, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05030337 - Optimising Ventilation in Preterms With Closed-loop Oxygen Control N/A
Completed NCT05144607 - Impact of Inspiratory Muscle Pressure Curves on the Ability of Professionals to Identify Patient-ventilator Asynchronies N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Completed NCT05084976 - Parental Perception of COVID-19 Vaccine in Technology Dependent Patients
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Completed NCT04429399 - Lowering PEEP: Weaning From High PEEP Setting N/A
Completed NCT02249039 - Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study Phase 1
Recruiting NCT02071524 - Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics N/A
Completed NCT01114022 - Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane N/A
Completed NCT00893763 - Strategies To Prevent Pneumonia 2 (SToPP2) Phase 2
Terminated NCT05056103 - Automated Secretion Removal in ICU Patients N/A
Active, not recruiting NCT04558476 - Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation Phase 2
Recruiting NCT05295186 - PAV Trial During SBT Trial
Active, not recruiting NCT05370248 - The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient N/A
Completed NCT04589910 - Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound. N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Completed NCT04193254 - LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU
Completed NCT06332768 - NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients N/A
Not yet recruiting NCT03259854 - Non Invasive Mechanical Ventilation VERSUS Oxygen MASK N/A
Not yet recruiting NCT03245684 - Assisted or Controlled Ventilation in Ards (Ascovent) N/A