Could a Half-Dose of steroids protect preterm Babies' brains just as well?
NCT ID NCT04021485
First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study follows 643 children who were born before 32 weeks of pregnancy and whose mothers received either a full or half dose of betamethasone before birth. Researchers will test the children's thinking skills, memory, and social behavior at age 5 to see if the lower dose is just as safe for brain development. The goal is to find out whether reducing steroid exposure can still protect the brain while avoiding unnecessary high doses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- betamethasone (half-dose vs full-dose regimen)
- What this could lead to
- If successful, this could show that a lower dose of betamethasone is safe for long-term brain development in preterm children, potentially reducing unnecessary steroid exposure.
- What could go wrong
- This is an observational follow-up, not a new treatment trial. The earlier BETADOSE trial did not prove the half-dose was non-inferior for breathing problems, so the lower dose may not be adopted even if neurodevelopment looks similar.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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386 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 6 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Singleton child born from mother enrolled in the BETADOSE trial, * Gestational age at birth less than 32 weeks of gestation, * Age ≥ 5 years and \< 6 years, alive and not lost of follow up * Informed consent of the holder (s) of the exercise of parental authority * Affiliation to a social security scheme. Exclusion Criteria: * Major malformations and chromosomal aberrations evidenced after birth, * Parents' refuse to participate.
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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.
Contacts and locations
Locations
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Hôpital Robert Debré
Paris, Pa, 75019, France