NCT06401083 The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate
| NCT ID | NCT06401083 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Semmelweis University |
| Condition | Apnea of Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 226 participants |
| Start Date | 2023-12-21 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 226 participants in total. It began in 2023-12-21 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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; * Had not received surfactant treatment; * Hydrops foetalis; * Persistent tachycardia before extubation, fetal/neonatal arrhythmia; * Asphyxia.
Contact & Investigator
Ákos Gasparics, MD.PhD
PRINCIPAL INVESTIGATOR
Semmelweis University, Department of Obstetrics and Gynecology
Frequently Asked Questions
Who can join the NCT06401083 clinical trial?
This trial is open to participants of all sexes, studying Apnea of Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06401083 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06401083 currently recruiting?
Yes, NCT06401083 is actively recruiting participants. Contact the research team at kovacs.kinga1@semmelweis.hu for enrollment information.
Where is the NCT06401083 trial being conducted?
This trial is being conducted at Budapest, Hungary, Budapest, Hungary.
Who is sponsoring the NCT06401083 clinical trial?
NCT06401083 is sponsored by Semmelweis University. The principal investigator is Ákos Gasparics, MD.PhD at Semmelweis University, Department of Obstetrics and Gynecology. The trial plans to enroll 226 participants.