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

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ClinicalTrials.gov Identifier: NCT04251286
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : May 26, 2020
Sponsor:
Collaborators:
Xuzhou Maternity and Child Health Care Hospital
Jiangsu Women and Children Health Hospital
Changzhou Maternity and Child Health Care Hospital
Lianyungang Maternity and Child Health Care Hospital
Affiliated Hospital of Jiangsu University
Suqian First Hospital
Jiangyin People's Hospital
Nantong Maternity and Child Health Care Hospital
The Affiliated Hospital of Xuzhou Medical University
Taizhou People's Hospital
Yangzhou Maternity and Child Health Care Hospital
Yangzhou University
Information provided by (Responsible Party):
Zhangbin Yu, 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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network:A Multicentrd, Prospective, Open, Clinical Study
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice




Primary Outcome Measures :
  1. To record the TCB values of Chinese newborns within 28 days after birth. [ Time Frame: 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.

  2. The comprehensive prognosis of infants [ Time Frame: 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 :
  1. Risk factors of extreme hyperbilirubinemia [ Time Frame: 36 months ]
    Extreme hyperbilirubinemia:total serum bilirubin more than 25mg/dL.

  2. The incidence of neurological sequelae. [ Time Frame: 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

  3. The completion rate of each jaundice management measure for severe hyperbilirubinemia cases. [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251286


Contacts
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Contact: Han Shuping, PHD +86-025-52226561 shupinghan@njmu.edu.cn
Contact: Yu Zhangbin, PHD +86-025-52226567 yuzhangbin@126.com

Locations
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China, Jiangsu
Nanjing Maternity and Child Health Care Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Han Shuping, PHD    +86-025-52226561    shupinghan@njmu.edu.cn   
Contact: Yu Zhangbin, PHD    +86-025-52226567    yuzhangbin@126.com   
Sponsors and Collaborators
Nanjing Medical University
Xuzhou Maternity and Child Health Care Hospital
Jiangsu Women and Children Health Hospital
Changzhou Maternity and Child Health Care Hospital
Lianyungang Maternity and Child Health Care Hospital
Affiliated Hospital of Jiangsu University
Suqian First Hospital
Jiangyin People's Hospital
Nantong Maternity and Child Health Care Hospital
The Affiliated Hospital of Xuzhou Medical University
Taizhou People's Hospital
Yangzhou Maternity and Child Health Care Hospital
Yangzhou University
Investigators
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Study Director: Han Shuping, PHD Nanjing Maternity and Child Health Care Hospital
Study Director: Yu Zhangbin, PHD Nanjing Maternity and Child Health Care Hospital
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 Maternity and Child Health 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
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Responsible Party: Zhangbin Yu, Principal Investigator of Nan Jing Maternity and Child Health Care Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04251286    
Other Study ID Numbers: NMU-FY2018-54
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: The Study Protocol will be shared after the publication until the end of the study.
Access Criteria: All participating centres

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhangbin Yu, Nanjing Medical University:
Hyperbilirubinemia
screening
follow-up
Additional relevant MeSH terms:
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Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Infant, Newborn, Diseases