Caffeine citrate loading dose before extubation in preterm infants
The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate
PHASE4 · Semmelweis University · NCT06401083
This study tests if giving a dose of caffeine to preterm babies before they are taken off the ventilator can help them breathe better and stay off the machine successfully.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Sex | All |
| Sponsor | Semmelweis University (other) |
| Locations | 2 sites (Budapest and 1 other locations) |
| Trial ID | NCT06401083 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born before the 32nd week of gestation who have been mechanically ventilated for at least 48 hours prior to planned extubation.
Not a fit: Patients with major congenital anomalies or those who have not received surfactant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance extubation success rates and improve respiratory outcomes for preterm infants.
How similar studies have performed: Previous studies have shown varying results regarding the efficacy of caffeine in improving extubation outcomes, making this approach both relevant and necessary to explore further.
Eligibility criteria
Show full inclusion / exclusion 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; * Had not received surfactant treatment; * Hydrops foetalis; * Persistent tachycardia before extubation, fetal/neonatal arrhythmia; * Asphyxia.
Where this trial is running
Budapest and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Apnea of Prematurity, Premature Birth, Respiratory Failure, prematurity, caffeine, methylxanthine, apnea of prematurity, extubation failure