Multi-center Clinical Study on Neonatal Hyperbilirubinemia

Quality Improvement Clinical Trial

Official title:

Multi-center Clinical Study on Early Screening and Treatment of Hyperbilirubinemia of Term and Late-preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824990
• Other study ID #: NMU-FY2018-72
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Quality Improvement

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