Caffeine citrate loading dose before extubation in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of a single loading dose of caffeine citrate on the success rate of extubation in preterm neonates born before the 32nd week of gestation. The study involves randomly allocating infants who have been mechanically ventilated for at least 48 hours into intervention and control groups. Researchers will also monitor the frequency of apneas, side effects, and long-term neurodevelopmental outcomes associated with the intervention. The goal is to determine if the additional caffeine dose can improve respiratory function and reduce extubation failure rates.

Why it matters

Who can join: the full rules

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;
* Had not received surfactant treatment;
* Hydrops foetalis;
* Persistent tachycardia before extubation, fetal/neonatal arrhythmia;
* Asphyxia.

Where it's running

• Pediatric Center, Semmelweis University
  Budapest, Hungary Recruiting
• Department of Obstetrics and Gynecology, Semmelweis University
  Budapest, Hungary Recruiting

Study contacts

• Principal investigator: Ákos Gasparics, MD.PhD — Semmelweis University, Department of Obstetrics and Gynecology
• Study coordinator: Kinga Kovács, MD.
• Email: kovacs.kinga1@semmelweis.hu
• Phone: +36206663718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.