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

NCT ID: NCT04251286

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Hyperbilirubinemia, Neonatal

Keywords

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Hyperbilirubinemia screening follow-up

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xuzhou Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Jiangsu Women and Children Health Hospital

UNKNOWN

Sponsor Role collaborator

Changzhou Maternal and Child Care Hospital

OTHER

Sponsor Role collaborator

Lianyungang Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of Jiangsu University

OTHER

Sponsor Role collaborator

Suqian First Hospital

OTHER

Sponsor Role collaborator

Jiangyin People's Hospital

OTHER

Sponsor Role collaborator

Nantong Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

Taizhou People's Hospital

UNKNOWN

Sponsor Role collaborator

Yangzhou Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Yangzhou University

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhangbin Yu

Principal Investigator of Nan Jing Maternity and Child Health Care Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han Shuping, PHD

Role: STUDY_DIRECTOR

Nanjing Maternity and Child Health Care Hospital

Yu Zhangbin, PHD

Role: STUDY_DIRECTOR

Nanjing Maternity and Child Health Care Hospital

Deng Xiaoyi, MD

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Maternity and Child Health Care Hospital

Hu Yuhua, PHD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Women and Children Health Hospital

Wang Jinxiu, PHD

Role: PRINCIPAL_INVESTIGATOR

Changzhou Maternal and Child Care Hospital

Li Qianqian, MD

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Maternity and Child Health Care Hospital

Gao Yan, MD

Role: PRINCIPAL_INVESTIGATOR

Lianyungang Maternity and Child Health Care Hospital

Lu Hongyan, MD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiangsu University

Zhang Jia, MD

Role: PRINCIPAL_INVESTIGATOR

Suqian First Hospital

Wan Jun, MD

Role: PRINCIPAL_INVESTIGATOR

Jiangyin People's Hospital

Li Shuangshuang, MD

Role: PRINCIPAL_INVESTIGATOR

Nantong Maternity and Child Health Care Hospital

Wu Mingfu, MD

Role: PRINCIPAL_INVESTIGATOR

Yangzhou University

Wu Xinping, MD

Role: PRINCIPAL_INVESTIGATOR

Yangzhou Maternity and Child Health Care Hospital

Wang Jun, MD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Xue Mei, MD

Role: PRINCIPAL_INVESTIGATOR

Taizhou People's Hospital

Locations

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Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Han Shuping, PHD

Role: CONTACT

Phone: +86-025-52226561

Email: [email protected]

Yu Zhangbin, PHD

Role: CONTACT

Phone: +86-025-52226567

Email: [email protected]

Facility Contacts

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Han Shuping, PHD

Role: primary

Yu Zhangbin, PHD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33550236 (View on PubMed)

Other Identifiers

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NMU-FY2018-54

Identifier Type: -

Identifier Source: org_study_id