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Caffeine administration for preterms in nociception outcomes
EU CTIS ID: 2025-523475-33-00
What this study is testing
The primary objective is to evaluate the salivary caffeine concentrations during the study with respect to the efficacy outcome measured as the cumulative duration of invasive respiratory support (IRS).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients are eligible for the trial if they meet all the following criteria: 1) Gestational age for extreme preterm (24+0 – 27+6 weeks GA) or very early preterm (28+0–32+6 weeks GA) newborn 2) Indication for the treatment with caffeine citrate (Peyona) decided by the attending neonatologist 3) Intravenous access port present of planned to be inserted on Day 0 because of the health status of the patient 4) Medical condition that allows saliva collection using a sterile gauze pad 5) Signed informed consent from one of the parents
You likely can't join if
- Patients will not be eligible for the trial if they meet any of the following criteria: 1) Caffeine contraindication according to the SmPC 2) Presence of severe congenital malformation or peripartal trauma affecting cerebral blood flow and/or cardiovascular function 3) Serious or life-threatening conditions causing partial or complete loss of sensitivity 4) Post-surgical status (recent major surgical intervention) of the infant or planned major surgery in the next 4 weeks 5) Congenital defect of the urogenital system known to affect renal function
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.