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

Recruiting

• Conditions: Hyperbilirubinemia, Neonatal

• Registration Number: NCT04251286
• Lead Sponsor: Nanjing Medical University

Brief 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.

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Study Start: 2020-05-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.

Exclusion Criteria

• Biliary atresia, serious genetic and metabolic diseases, family history of epilepsy, and so on.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To record the TCB values of Chinese newborns within 28 days after birth.	12 months	Transcutaneous bilirubin (TcB) values will be recorded so as to establish transcutaneous bilirubin nomogram in healthy Chinese term and late-preterm infants at \<28 days of age.
The comprehensive prognosis of infants	60 months	To investigate the comprehensive prognosis of infants with severe hyperbilirubinemia at the corrected age of 2 years in a real-world setting in Jiangsu Province.

Secondary Outcome Measures

Name	Time	Method
The incidence of neurological sequelae.	60 months	To assess the clinical outcome at 2 years of corrected age in cases treated with and without exchange transfusion when TSB is at a level of the threshold
Risk factors of extreme hyperbilirubinemia	36 months	Extreme hyperbilirubinemia:total serum bilirubin more than 25mg/dL.
The completion rate of each jaundice management measure for severe hyperbilirubinemia cases.	36 months	To calculate the completion rate of each jaundice management measure for severe hyperbilirubinemia cases, whose total serum bilirubin are more than 20mg/dL

Trial Locations

Locations (1)

Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China