Could a common painkiller boost brain development in preemies?
NCT ID NCT06064825
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 500 extremely preterm infants who received paracetamol or placebo in the TREOCAPA trial. Researchers will use a parent questionnaire to assess cognitive development at age 2. The goal is to see if early paracetamol use improves thinking and learning skills in these vulnerable children.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paracetamol (acetaminophen)
- What this could lead to
- If successful, this could show that early paracetamol treatment helps prevent cognitive delays in extremely preterm infants.
- What could go wrong
- This is a follow-up study, not a new treatment trial. Results depend on parent reports, which may not be fully accurate, and the original trial may not show a clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population for the follow-up study of the TREOCAPA trial consists of all children included in phase III of the trial from centres participating in the follow-up study. The parents of children who survived to two years corrected age and meet the criteria for inclusion will be offered the opportunity to complete the questionnaire.
- Ages
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23 to 27 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * were included in the TREOCAPA phase III RCT in participating centres * are aged between 23.5 and 27.5 months corrected age during the study period Exclusion Criteria: * if the local investigator does not have up-to-date contact information allowing contact with parents * if the child's vital status cannot be ascertained * if the child is nearing the end of his life or experiencing a severe medical event as assessed by the local investigator * if the child has become subject to a legal protection measure preventing their ongoing participation in clinical research * if either parent or guardian opts out of participating * language barrier
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU d'Angers
RECRUITINGAngers, France
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CHU de Montpellier
RECRUITINGMontpellier, France
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CHU de Nantes
RECRUITINGNantes, France
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CHU de Strasbourg
RECRUITINGStrasbourg, France
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CHU de Tours
RECRUITINGTours, France
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Cochin - APHP
RECRUITINGParis, France
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Hopital Robert Debré
RECRUITINGParis, France
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Hôpital Femme Mère Enfant
RECRUITINGBron, France