What is this study trying to find out about seizures in newborns?

This study is evaluating how often new seizures start or are newly diagnosed in newborn babies up to 28 days old. Researchers use EEG to monitor brain activity and collect other health and background information to understand seizure risks. The Children's Hospital of Fudan University is leading this research to improve knowledge of neonatal seizures.

Who may be eligible for this neonatal seizure clinical trial?

Babies from birth to 28 days old who have been clinically and EEG diagnosed with seizures may be eligible. Parents must provide consent for participation. This study includes all genders and excludes babies whose parents cannot comply with study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this neonatal seizure clinical trial?

Study-related care, including EEG monitoring and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect all necessary tests and follow-ups to be arranged as part of the study.

Actively Recruiting

Age: 0 - 28Days

All Genders

ID02552511

Observational Study on Seizures in Newborn Babies Up to 28 Days Old in China

Led by Children's Hospital of Fudan University · Updated on 2025-09-05

1400

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to describe how often new seizures start or are newly diagnosed in newborn babies up to 28 days old. It focuses on babies with uncontrolled seizures, which can be linked to high-risk factors during the time around birth. Researchers study abnormal electrical activity in the brain to understand these seizures better. To do this, the study uses electroencephalography EEG to monitor and record brain electrical activity in newborns suspected of having seizures. Along with EEG recordings, information about the babies demographics, medical history, family background, birth details, growth, and feeding is collected through medical records and questionnaires. This helps identify factors that may influence seizure occurrence in newborns. Participants will be followed from birth until 28 days old to record seizure incidence and monitor brain activity using EEG within 14 days after any seizure. At 18 months corrected age, neurodevelopment and neurological function are assessed using specific scoring systems. Genetic testing is also done within 30 days of DNA sample collection. The study collects detailed information to better understand seizure risks and outcomes in newborns.

CONDITIONS

Brief Title

Epidemiology Study on Neonatal Seizure

Who Can Participate

Age: 0 - 28Days

All Genders

Eligibility Criteria

You may qualify if you...

Age from 0 to 28 days
Clinical diagnosis of seizure
EEG diagnosis of seizure
Parents who consent to participation in the study

You will not qualify if you...

Parents who will not comply with the study requirements and design process

Your Study Journey

Screening

Duration - Up to 28 days from birth

Participants are screened for eligibility to participate in the trial.

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Diagnostic Evaluation

Duration - Within 14 days after seizure attack

Participants undergo EEG to determine and monitor uncontrolled or suspected seizures, along with collection of medical records and questionnaires about demographic, family, perinatal, birth, growth, and feeding conditions.

1 to 2 visits depending on seizure occurrence

Long-term Monitoring

Duration - Up to 18 months after birth

Participants are followed to observe neurodevelopment and neurological status at corrected age of 18 months, including Bayley Scores and GMFM-88 assessments, as well as gene mutation analysis from DNA samples.

1 visit at corrected age of 18 months and 1 visit about 30 days after DNA sample collection