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New treatment option for Apnea of Prematurity
Official title The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate
ClinicalTrials.gov ID: NCT06401083
What this study is testing
What is Caffeine citrate?
Caffeine citrate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for apnea of prematurity.
Also referred to as CITRATE DE CAFEINE COOPER 25 mg/ml Coopération Pharmaceutique Française, Melun, France.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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 likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Budapest, Hungary
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Budapest, Hungary. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.