Multi-center Clinical Study on Neonatal Hyperbilirubinemia

Not Applicable

Completed

• Conditions: Quality Improvement; Hyperbilirubinemia, Neonatal
• Interventions: Behavioral: Quality improvement of management of neonatal jaundice

• Registration Number: NCT03824990
• Lead Sponsor: Nanjing Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Primary Completion: 2021-08-31
• Status Verified: 2021-10
• Study Completion: 2021-10-15
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention phase	Quality improvement of management of neonatal jaundice	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.
Sustainability intervention phase	Quality improvement of management of neonatal jaundice	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.

Primary Outcome Measures

Name	Time	Method
The incidence of bilirubin encephalopathy	18 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China