Multi-center Clinical Study on Neonatal Hyperbilirubinemia

Nanjing Medical University

Status: Completed

Conditions: Hyperbilirubinemia, Neonatal; Quality Improvement

Treatments: Behavioral: Quality improvement of management of neonatal jaundice

Study type: Interventional

Funder types: Other

Identifiers

NCT03824990

NMU-FY2018-72

Details and patient eligibility

About

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

Full 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.

Enrollment: 20,000 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20,000 participants in 3 patient groups

Before-intervention phase

No Intervention group

Description:

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

Intervention phase

Experimental group

Description:

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.

Treatment:

Behavioral: Quality improvement of management of neonatal jaundice

Sustainability intervention phase

Experimental group

Description:

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.

Treatment:

Behavioral: Quality improvement of management of neonatal jaundice