Investigating genetic factors in neonatal jaundice
The Effect and Mechanism of Gene Variation on Neonatal Hyperbilirubinemia
This study is trying to see if certain genetic factors are linked to jaundice in newborns by looking at blood samples and bilirubin levels from babies aged 1 to 28 days.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06186349 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between genetic variations and neonatal hyperbilirubinemia (NHB) by analyzing 2,000 neonatal dry blood spot samples for 24 genetic screening tests related to NHB. The study will collect clinical data and bilirubin levels from newborns aged 1-28 days, focusing on understanding how genetic factors influence the clinical manifestations of jaundice. Additionally, the study will provide genetic counseling to families of newborns with positive test results to help them understand the implications of genetic findings.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns aged 1-28 days with a gestational age of at least 35 weeks and a birth weight between 2.5 kg and 4 kg.
Not a fit: Patients who may not benefit from this study include those with severe deformities or lethal inherited metabolic diseases, as well as those with unclear clinical information.
Why it matters
Potential benefit: If successful, this study could lead to improved genetic screening and management strategies for neonatal hyperbilirubinemia.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated that genetic factors play a significant role in neonatal hyperbilirubinemia, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 1-28 days * gestational age ≥ 35 weeks * Birth weight ≥ 2.5 kg and \< 4 kg. Exclusion Criteria: * Neonatal data with unclear clinical basic information ; * Lack of traceability core information data ; * data that the test results cannot be analyzed and interpreted ; * Sample collection is not qualified and unwilling to cooperate with re-sampling. * Newborns with severe deformity and severe lethal inherited metabolic diseases
Where this trial is running
Guangzhou, Guangdong
- The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hu Hao
- Email: haohu@mail.sysu.edu.cn
- Phone: 86-020-38777850
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.