Common allergy drug may heal brain damage in preterm infants
NCT ID NCT07688746
First seen Jul 07, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This study tests whether clemastine, an allergy medicine, is safe for premature babies with white matter injury—a common brain injury in infants born early. Researchers will give the drug by mouth to 24 babies born at or before 32 weeks and now between 35 and 41 weeks old. The goal is to check for side effects and learn how the drug moves through their bodies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clemastine (an antihistamine drug)
- What this could lead to
- If safe, this could point toward a treatment to repair brain damage in premature infants.
- What could go wrong
- This is an early, small safety study in 24 babies, so it may not show benefit or could reveal unexpected side effects.
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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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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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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3 to 20 weeks
- 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: 1. Born at ≤32 weeks gestational age based on prenatal ultrasound or last menstrual period (LMP). 2. Current age of between 35-41 weeks PMA. 3. Imaging evidence of white matter injury on any scan as defined by either brain MRI or cUS criteria: * Brain MRI with Grade Ib WMI or higher based on the Martinez-Biarge et al 2016 criteria. * cUS with Grade 3 or higher white matter abnormalities based on Miller et al 2003 criteria. 4. Currently hospitalized in a participating intensive care nursery. Exclusion Criteria: 1. Known or suspected metabolic or chromosomal disorder or major congenital anomalies 2. Major intracranial hemorrhage within the last 1 week or intracranial hemorrhage of any age that is not controlled or continuing to cause significant mass effect or midline shift. 3. History of cardiac arrhythmia or current ongoing tachycardia with baseline heart rate \>10% age expected norms. 4. Hypotension requiring ongoing vasopressor or inotropic support. 5. Not able to receive enteral medications. 6. Clinically significant sedation due to critical illness or medications. 7. Concomitant use of any other putative neuroprotective or myelination promoting therapy as determined by the investigator. 8. Serum creatinine, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \>2x the upper limit of normal for age. 9. Family history of epilepsy due to a confirmed or suspected genetic cause. 10. History of confirmed seizure activity. 11. If ≥36 weeks postmenstrual age, required respiratory support greater than 2L/min, noninvasive positive airway pressure, or mechanical ventilation upon reaching 36 weeks postmenstrual age due to diagnosis of moderate or severe BPD. 12. If less than 36 weeks postmenstrual age, currently requiring respiratory support greater than 2L/min, noninvasive positive airway pressure, or mechanical ventilation, unless respiratory support is being given to promote lung development and not due to clinical need. 13. Major medical conditions, laboratory abnormalities, or concurrent treatments that, in opinion of the investigator, may affect interpretation of study results or patient safety.
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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
1 site. 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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University of California, San Francisco
RECRUITINGSan Francisco, California, 94158, United States
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Other studies related to the condition(s) this trial covers.
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