Extremely Low Gestatonal Age Infants' Paracetamol Study (NCT03641209) | Clinical Trial Compass
CompletedPhase 1/2
Extremely Low Gestatonal Age Infants' Paracetamol Study
Finland40 participantsStarted 2018-09-03
Plain-language summary
In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
Who can participate
Age range
96 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Premature infants born before 28+0 gestation weeks and/or birth weight less than 1000g
Exclusion Criteria:
* Severe malformation or suspected chromosomal defect or other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already completed, would my baby's doctor be able to share or access any findings about whether paracetamol helped close the ductus arteriosus in extremely premature or very low birthweight infants like mine?
2This was a Phase 1/Phase 2 study, which means it was still in early stages of testing safety and dosing — does that mean there are still unknowns about how safe or effective paracetamol is for closing the ductus in babies born at this gestational age?
3Are there other treatments, like indomethacin or ibuprofen, or even watchful waiting, that my baby's care team would consider alongside or instead of paracetamol for ductal closure, and how do those options compare based on what's currently known?
4Given that this trial focused specifically on extremely preterm and very low birthweight infants under 999 grams, does my baby fall within a similar profile where this research might actually be relevant to decisions about their care?
5What would the signs be that my baby's ductus arteriosus needs treatment at all, and would my doctor consider paracetamol as an option based on the evidence available from studies like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ductal closure
Timeframe: Neonatal intensive care unit (NICU) treatment period up to 13 weeks