NCT04251286

Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network

Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network：A Multicentrd, Prospective, Open, Clinical Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

Summary

At least 13 hospitals in China will participate in the study, which aims to clarify the natural history of jaundice in Chinese healthy newborns，and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. The study is an open project, and the investigators welcome institutions fulfilling the specified requirements to join the study during the recruitment phase.

Detailed description

This is a prospective cohort study of healthy term and near-term infants. The mobile network screening and follow-up of neonatal jaundice consists of two parts, one is the screening and follow-up program for healthy neonatal jaundice by using on parents' mobile phones, the other is the online registry of severe hyperbilirubinemia. Firstly，the TCB values of healthy term and near-term infants in delivery institutions will be prospectively recorded and followed up until jaundice subsided by using screening and follow-up program, so as to clarify the natural history of jaundice of healthy newborns in China. Secondly, by establishing an online registry for severe hyperbilirubinemia and "Follow up of jaundice" on Wechat applet, the investigators will find the specific problems of jaundice management in infants with severe hyperbilirubinemia. Lastly, through the follow-up of severe hyperbilirubinemia cases, the investigators will have a better understanding of their prognosis.

Conditions

• Hyperbilirubinemia, Neonatal

Timeline

• Start date: 2020-05-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2020-01-31
• Last updated: 2021-11-01

Locations

1 site across 1 country: China