Multi-center Clinical Study on Neonatal Hyperbilirubinemia

Study Overview
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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.

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

Conditions
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Quality Improvement, Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Behavioral: Quality improvement of management of neonatal jaundice


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Before-intervention phase<br>All the healthy infants who were admitted from March 2018 to August 2018 to the Well Baby nurse of different hospitals. | |
| Experimental: Intervention phase<br>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. | Behavioral: Quality improvement of management of neonatal jaundice<br>* During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.<br>|
| Experimental: Sustainability intervention phase<br>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. | Behavioral: Quality improvement of management of neonatal jaundice<br>* During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of bilirubin encephalopathy |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of severe hyperbilirubinemia | Severe hyperbilirubinemia:total serum bilirubin more than 20mg/dL | 18 months | 
| The rate of lost to follow-up | The rate of lost to follow-up for jaundice after discharge from well-baby nursery | 18 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality improvement, Hyperbilirubinemia, screening, follow-up