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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05454332
• Other study ID #: 2021-0463
• Status: Recruiting
• Phase: Phase 4
• Start date: April 27, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: May 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Gabriela Trindade
• Phone: +55 51 985002009
• Email: gabs.trindade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Hours

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Caffeine
• Mechanical Ventilation Complication
• Ventilator Lung; Newborn

Intervention

Drug:
• Early Caffeine administration
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.

Other:
• Control Group
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

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