Massive newborn brain study launches in china
NCT ID NCT02544100
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study aims to create a large database of medical information and biological samples from 2,000 newborns with brain conditions like encephalopathy. Researchers will collect blood, urine, and spinal fluid samples, along with genetic data, to better understand and monitor brain injury. The goal is to use this big data to predict brain damage and guide treatment in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better ways to monitor and predict brain injury in newborns, and provide a rich data resource for future research.
- What could go wrong
- This is an observational study, not a treatment trial. It collects data and samples, so it won't directly help participants. Results may take years to impact care.
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 2,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2015
- Expected to finish
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Dec 2025
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.
Who is studied
Neonatal with severe encephalopathy or suspected severe encephalopathy.
- Ages
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Up to 28 days
- 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. Postnatal age \< or = 28 days 2. Written informed consent of parent or guardian With one of the following items 3. Hypoxic ischemic encephalopathy (HIE) 4. Hydrocephalus 5. Hypotonia 6. Interventricular hemorrhages 7. Intracranial calcifications 8. Intracranial hemorrhages 9. Meningitis and other brain infections 10. Metabolic diseases 11. Microcephaly 12. Neonatal stroke 13. Spina bifid 14. Cerebral arteriovenous malformations (AVMs) 15. Congenital brain malformations Exclusion Criteria: 1. Known other major congenital anomalies but not not neurologic disease. 2. Failed to get sample or the volume of collected biosamples is not enough. 3. Parents refuse consent.
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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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Children Hospital of Fudan University
RECRUITINGShanghai, Shanghai Municipality, 201102, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Baby eye exams may reveal hidden brain injury
- New sensor reveals how newborn brains adapt after birth
- New Light-Based monitor could help protect newborn brains
- New study maps normal heart function in newborns