The Caffeine Therapy in the Fetal to Neonatal Transition

NCT05454332 | Recruiting Phase 4

• 1 other identifier: 2021-0463
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication; Caffeine; Ventilator Lung; Newborn

Outcome Measures

Primary Outcomes (1)

• Necessity of intubation

  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.

  first week of life

Secondary Outcomes (4)

• mechanical ventilation time

  until first successful extubation (followed up at least until 36 weeks of corrected age, discharge or death)

• Number of Participants with Bronchopulmonary dysplasia

  followed up at least until 36 weeks of corrected age, discharge or death.

• Number of Participants with Intracranial hemorrhage

  followed up at least until 36 weeks of corrected age, discharge or death.

• Number of Participants with Retinopathy of prematurity

  followed up at least until 36 weeks of corrected age, discharge or death.

Study Arms (2)

Early Caffeine Group

EXPERIMENTAL

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.

Drug: Early Caffeine administration

Control Group

ACTIVE COMPARATOR

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.

Other: Control Group

Interventions

Early Caffeine administration DRUG

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.

Early Caffeine Group

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: Up to 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature newborns with birth weight less than 1250 grams
• Who are not intubated in the delivery room

You may not qualify if:

• Premature newborns from other hospitals
• Presence of a major congenital malformation or genetic syndrome

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Gabriela Trindade

CONTACT

+55 51 985002009; gabs.trindade@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: April 27, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 2, 2025

Record last verified: 2024-05

Locations

BR (1)