Multi-center Clinical Study on Neonatal Hyperbilirubinemia

NCT ID: NCT03824990

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-10-15

Brief Summary

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Eight hospitals in China will participate in the study, which aims to decrease the incidence of severe hyperbilirubinemia.

Detailed Description

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Through a prospective cohort study of healthy term and near-term infants, the study tries to truly reflect the epidemiology, intervention status, and outcomes of neonatal hyperbilirubinemia and the cost. Hopefully, by improving the quality of management of neonatal jaundice,we can explore and obtain a healthy term and near-term jaundice management model suitable for China's national condition, which can eventually reduce the incidence rate of neonatal severe hyperbilirubinemia and bilirubin encephalopathy.

Conditions

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Quality Improvement Hyperbilirubinemia, Neonatal

Keywords

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Quality improvement Hyperbilirubinemia screening follow-up

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Before-intervention phase

All the healthy infants who were admitted from March 2018 to August 2018 to the Well Baby nurse of different hospitals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention phase

All the healthy infants who were admitted from September 2018 to February 2019 to the Well Baby nurse of different hospitals.During this phase,multiple intervention bundles of quality improvement will be implemented.

Group Type EXPERIMENTAL

Quality improvement of management of neonatal jaundice

Intervention Type BEHAVIORAL

During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.

Sustainability intervention phase

All the healthy infants who were admitted from March 2019 to August 2019 to the Well Baby nurse of different hospitals.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented.

Group Type EXPERIMENTAL

Quality improvement of management of neonatal jaundice

Intervention Type BEHAVIORAL

During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.

Interventions

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Quality improvement of management of neonatal jaundice

During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Infants admitted to a higher level of intervention before discharge.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JiLin Women and Children Health Hospital

UNKNOWN

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Shan Dong Qian Fo Shan Hospital

UNKNOWN

Sponsor Role collaborator

Shan Dong Liao Cheng Hospital

UNKNOWN

Sponsor Role collaborator

Guangxi Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

OTHER

Sponsor Role collaborator

Yin Chuan Maternity and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhangbin Yu

Nan Jing Maternity and Child Health Care Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuping Han, PHD

Role: STUDY_DIRECTOR

Nanjing Maternity and Child Health Care Hospital

Zhangbin Yu, PHD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Maternity and Child Health Care Hospital

Zhiyong Sun, PHD

Role: PRINCIPAL_INVESTIGATOR

JiLin Women and Children Health Hospital

Haiyan Cai, PHD

Role: PRINCIPAL_INVESTIGATOR

Qinhuangdao Maternal and Child Health Care Hospital

Yonghui Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Hospital

Xin Yuan, MD

Role: PRINCIPAL_INVESTIGATOR

Shan Dong Qian Fo Shan Hospital

Jin Qian, MD

Role: PRINCIPAL_INVESTIGATOR

Shan Dong Liao Cheng Hospital

Jimei Wang, PHD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics & Gynecology Hospital of Fudan University

Wenyan Tang, PHD

Role: PRINCIPAL_INVESTIGATOR

Jiangxi Maternal and Child Health Hospital

Qiufen Wei, PHD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Maternal and Child Health Hospital

Zhankui Li, PHD

Role: PRINCIPAL_INVESTIGATOR

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Jie Gu, PHD

Role: PRINCIPAL_INVESTIGATOR

Yin Chuan Maternity and Child Health Hospital

Locations

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Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NMU-FY2018-72

Identifier Type: -

Identifier Source: org_study_id