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

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251286
• Other study ID #: NMU-FY2018-54
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: October 2021
• Source: Nanjing Medical University
• Contact: Han Shuping, PHD
• Phone: +86-025-52226561
• Email: shupinghan[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Jaundice
• Jaundice, Neonatal

Locations

Country	Name	City	State
China	Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (13)

Lead Sponsor

Collaborator

Nanjing Medical University

Affiliated Hospital of Jiangsu University, Changzhou Maternal and Child Care Hospital, Jiangsu Women and Children Health Hospital, Jiangyin People's Hospital, Lianyungang Maternity and Child Health Care Hospital, Nantong Maternity and Child Health Care Hospital, Suqian First Hospital, Taizhou People's Hospital, The Affiliated Hospital of Xuzhou Medical University, Xuzhou Maternity and Child Health Care Hospital, Yangzhou Maternity and Child Health Care Hospital, Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To record the TCB values of Chinese newborns within 28 days after birth.	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.	12 months
Primary	The comprehensive prognosis of infants	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.	60 months
Secondary	Risk factors of extreme hyperbilirubinemia	Extreme hyperbilirubinemia:total serum bilirubin more than 25mg/dL.	36 months
Secondary	The incidence of neurological sequelae.	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	60 months
Secondary	The completion rate of each jaundice management measure for severe hyperbilirubinemia cases.	To calculate the completion rate of each jaundice management measure for severe hyperbilirubinemia cases, whose total serum bilirubin are more than 20mg/dL	36 months