Monitoring bilirubin levels in healthy newborns
Self-Monitoring of Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates: a Multi-center Prospective Study
This study is testing how bilirubin levels change in healthy newborns during their first month of life to help better understand and identify jaundice in babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160000 (estimated) |
| Ages | 0 Days to 30 Days |
| Sex | All |
| Sponsor | Neonatal-Infant Brain and Behavior Development Network Research network |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06645158 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor transcutaneous bilirubin (TCB) levels in healthy near-term and full-term neonates from birth to 30 days of age across various regions in China. The study will develop a TCB nomogram to identify neonatal hyperbilirubinemia and compare TCB trends among different areas and gestational groups. By tracking these bilirubin levels, the study seeks to enhance understanding of neonatal health in relation to hyperbilirubinemia.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy neonates born at or after 35 weeks of gestation who are less than 30 days old.
Not a fit: Patients who require phototherapy within the first 60 hours of life will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early detection and management of hyperbilirubinemia in newborns, leading to better health outcomes.
How similar studies have performed: Other studies have shown success in monitoring bilirubin levels in neonates, making this approach both relevant and tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Gestational age \>=35wk; did not admitted to hospital for any reason Less than 30 days of age Exclusion Criteria: Accept phototherapy within 60h of age
Where this trial is running
Guangzhou, Guangdong
- Guangzhou Women and Children's Medical Center, — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Bi Ze, PhD candidate
- Email: zebi_sh@126.com
- Phone: +8615800590705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.