The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate
Recruiting
Phase 4
Interventional Study
Apnea of Prematurity
Premature Birth
Respiratory Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 226 (estimated)
- Sponsor
- Semmelweis University · Other
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About This Trial
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 neurod…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Premature infant born before 32nd week of gestation is completed;
* Had been mechanically ventilated for at least 48 hours;
* Before the first planned extubation.
Exclusion Criteria:
* Lack of informed consent, refusal to participate in the study;
* Major congenital anomaly;…
Contacts