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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperbilirubinemia, Neonatal

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 Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Yu Zhangbin, PHD; Phone Number: +86-025-52226567; Email: yuzhangbin@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing Maternity and Child Health Care Hospital
      • Contact: Yu Zhangbin, PHD; Phone Number: +86-025-52226567; Email: yuzhangbin@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For the research on the natural history of jaundice via mobile network, the selected population is healthy newborns with gestational age ≥35 weeks and weight ≥2000g, and those without phototherapy or hospital intervention. For the study of the online registry for severe hyperbilirubinemia, the study population is gestational age ≥35 weeks, weight ≥2000g, only hospitalized for jaundice, and the serum total bilirubin reached the threshold of exchange transfusion (≤3 days) or the serum total bilirubin ≥20mg / dl (>3 days).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors of extreme hyperbilirubinemia	Extreme hyperbilirubinemia:total serum bilirubin more than 25mg/dL.	36 months
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
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

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: Yangzhou University; Xuzhou Maternity and Child Health Care Hospital; Affiliated Hospital of Jiangsu University; Yangzhou Maternity and Child Health Care Hospital; Lianyungang Maternity and Child Health Care Hospital; Nantong Maternity and Child Health Care Hospital; The Affiliated Hospital of Xuzhou Medical University; Changzhou Maternal and Child Care Hospital; Jiangyin People's Hospital; Taizhou People's Hospital; Jiangsu Women and Children Health Hospital; Suqian First Hospital
• Investigators: Principal Investigator: Deng Xiaoyi, MD, Xuzhou Maternity and Child Health Care Hospital; Principal Investigator: Hu Yuhua, PHD, Jiangsu Women and Children Health Hospital; Principal Investigator: Wang Jinxiu, PHD, Changzhou Maternal and Child Care Hospital; Principal Investigator: Li Qianqian, MD, Xuzhou Maternity and Child Health Care Hospital; Principal Investigator: Gao Yan, MD, Lianyungang Maternity and Child Health Care Hospital; Principal Investigator: Lu Hongyan, MD, Affiliated Hospital of Jiangsu University; Principal Investigator: Zhang Jia, MD, Suqian First Hospital; Principal Investigator: Wan Jun, MD, Jiangyin People's Hospital; Principal Investigator: Li Shuangshuang, MD, Nantong Maternity and Child Health Care Hospital; Principal Investigator: Wu Mingfu, MD, Yangzhou University; Principal Investigator: Wu Xinping, MD, Yangzhou Maternity and Child Health Care Hospital; Principal Investigator: Wang Jun, MD, The Affiliated Hospital of Xuzhou Medical University; Principal Investigator: Xue Mei, MD, Taizhou People's Hospital

Publications and helpful links

General Publications

• Li Q, Deng X, Yan J, Sun X, Dong X, Chen X, Han S, Huo J, Yu Z. Neonatal Severe Hyperbilirubinemia Online Registry in Jiangsu Province: protocol for a multicentre, prospective, open, observational cohort study. BMJ Open. 2021 Feb 5;11(2):e040797. doi: 10.1136/bmjopen-2020-040797.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ANTICIPATED): April 30, 2025
• Study Completion (ANTICIPATED): April 30, 2025

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: follow-up; screening; Hyperbilirubinemia
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Jaundice; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice, Neonatal
• Other Study ID Numbers: NMU-FY2018-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study is an open project, and the collected data and information will be provided to all participating centers after review by the data management committee. Anyone interested in this research can contact us directly.
• IPD Sharing Time Frame: The Study Protocol will be shared after the publication until the end of the study.
• IPD Sharing Access Criteria: All participating centres
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No