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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03824990
Other study ID # NMU-FY2018-72
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date October 15, 2021

Study information

Verified date October 2021
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 20000
Est. completion date October 15, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility 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.

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
China Nanjing Maternity and Child Health Care Hospital Nanjing Jiangsu

Sponsors (8)

Lead Sponsor Collaborator
Nanjing Medical University Guangxi Maternal and Child Health Hospital, JiLin Women and Children Health Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Shan Dong Liao Cheng Hospital, Shan Dong Qian Fo Shan Hospital, Shandong Provincial Hospital, Yin Chuan Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of bilirubin encephalopathy 18 months
Secondary The incidence of severe hyperbilirubinemia Severe hyperbilirubinemia:total serum bilirubin more than 20mg/dL 18 months
Secondary The rate of lost to follow-up The rate of lost to follow-up for jaundice after discharge from well-baby nursery 18 months
Secondary The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia Patients with severe hyperbilirubinemia from 11 hospitals will be followed to investigate their neurological outcomes until 24 months after birth 42 months
Secondary Medical costs in patients with severe hyperbilirubinemia To compare the medical costs in patients with severe hyperbilirubinemia from 3 phases of quality improvement. 18 months
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