NCT06832800 Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH
| NCT ID | NCT06832800 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University |
| Condition | Neonatal Hyperbilirubinemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-07-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 250 participants in total. It began in 2025-07-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). It will also learn about the. occurrence of cranial MRI in the study participants. The main questions it aims to answer are: * Does MDT lower the possibilities participants have brain damage before the age of one? * How many times of abnormalities in cranial MRI is detected before the age of one? Researchers will compare MDT to a control (a current management) to see if MDT works to prevent brain damage in newborns with sHN. Participants will: * Take MDT or a control method in the management of sNH * Assess if there's brain damage before discharge and at the year of one * Record how many times of abnormalities in cranial MRI is detected before the age of one
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams * Infants with severe neonatal hyperbilirubinemia, including those whose serum total * bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB \> (threshold - 2) mg/dL). Exclusion Criteria: * Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
Contact & Investigator
Yingying Bao, Doctor
PRINCIPAL INVESTIGATOR
Women's Hospital, Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT06832800 clinical trial?
This trial is open to participants of all sexes, aged 4 Hours or older, up to 28 Days, studying Neonatal Hyperbilirubinemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06832800 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06832800 currently recruiting?
Yes, NCT06832800 is actively recruiting participants. Contact the research team at yingyingbao@zju.edu.cn for enrollment information.
Where is the NCT06832800 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06832800 clinical trial?
NCT06832800 is sponsored by Women's Hospital School Of Medicine Zhejiang University. The principal investigator is Yingying Bao, Doctor at Women's Hospital, Zhejiang University School of Medicine. The trial plans to enroll 250 participants.