Actively Recruiting
The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate
Led by Semmelweis University · Updated on 2024-05-06
226
Participants Needed
2
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to answer whether the use of a single loading dose (20 mg/kg) of caffeine citrate one hour before extubation has an impact on the success rate of extubation among preterm neonates. In addition, the investigators would like to assess the frequency of apneas and side effects of the intervention, as well as the development of NEC, BPD, IVH, PVL, and long-term neurodevelopmental outcomes in the investigated populations. According to institutional protocol, preterm infants born before the 32nd week of gestation receive a standard dose of caffeine citrate therapy. This covers a maintenance dose of 5-10 mg/kg of caffeine citrate administered intravenously once or twice daily after a loading dose of 20 mg/kg on the first day of life. In this trial, preterm infants born before the 32nd gestational week and who had been mechanically ventilated for at least 48 hours before planned extubation are planned to be randomly allocated into intervention and control groups. The intervention group will receive an additional loading dose of caffeine citrate 60 minutes before extubation. The control group will receive standard dosing regimens.
CONDITIONS
Official Title
The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premature infant born before 32nd week of gestation is completed
- Had been mechanically ventilated for at least 48 hours
- Before the first planned extubation
You will not qualify if you...
- Lack of informed consent or refusal to participate
- Major congenital anomaly
- Had not received surfactant treatment
- Hydrops foetalis
- Persistent tachycardia before extubation, fetal/neonatal arrhythmia
- Asphyxia
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Pediatric Center, Semmelweis University
Budapest, Hungary, 1083
Actively Recruiting
2
Department of Obstetrics and Gynecology, Semmelweis University
Budapest, Hungary, 1088
Actively Recruiting
Research Team
K
Kinga Kovács, MD.
CONTACT
Á
Ákos Gasparics, MD.PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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