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Search / Trial NCT06186349

The Effect and Mechanism of Gene Variation on Neonatal Hyperbilirubinemia

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Dec 26, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying neonatal hyperbilirubinemia (NHB), a condition that causes a yellowing of the skin in newborns due to high levels of bilirubin, a substance produced when the body breaks down old red blood cells. The researchers want to understand how genetic factors may influence the severity of jaundice in newborns. They will collect blood samples from 2,000 newborns and analyze specific genes that are linked to this condition. By doing this, they hope to improve early detection and treatment options for babies with NHB.

To participate in this study, newborns must be between 1 to 28 days old, born at least 35 weeks into the pregnancy, and weigh between 2.5 kg and 4 kg. The researchers will gather clinical information and bilirubin levels from the babies, looking for patterns that might help identify those at risk of severe jaundice. Parents can expect the study to involve simple blood tests and data collection, which will help advance our understanding of how genetic variations affect jaundice. This important work aims to guide better treatment and prevention strategies for affected newborns.

Gender

ALL

Eligibility 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

About Sixth Affiliated Hospital, Sun Yat Sen University

The Sixth Affiliated Hospital of Sun Yat-sen University is a leading medical institution in China, dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent academic hospital, it integrates clinical practice with research excellence, fostering collaboration among multidisciplinary teams to enhance medical knowledge and improve patient outcomes. The hospital is committed to conducting rigorous clinical trials that adhere to the highest ethical standards, aiming to contribute to the global scientific community and support the development of new therapies and interventions. With a focus on translational medicine, the Sixth Affiliated Hospital actively engages in pioneering studies that address critical health challenges and promote evidence-based practices in diverse medical fields.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

Hu Hao

Study Director

Department of Pediatrics, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported