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

NCT04251286 | Unknown DMC

• 1 other identifier: NMU-FY2018-54
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal

Keywords

Hyperbilirubinemia; screening; follow-up

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Risk factors of extreme hyperbilirubinemia

  36 months

• The incidence of neurological sequelae.

  60 months

• The completion rate of each jaundice management measure for severe hyperbilirubinemia cases.

  36 months

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33550236 DERIVED

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Han Shuping, PHD

  Nanjing Maternity and Child Health Care Hospital

  STUDY DIRECTOR

• Yu Zhangbin, PHD

  Nanjing Maternity and Child Health Care Hospital

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Shuping, PHD

CONTACT

+86-025-52226561; shupinghan@njmu.edu.cn

Yu Zhangbin, PHD

CONTACT

+86-025-52226567; yuzhangbin@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Nan Jing Maternity and Child Health Care Hospital

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 31, 2020
• Study Start: May 1, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The Study Protocol will be shared after the publication until the end of the study.
• Access Criteria: All participating centres

Locations

CN (1)