Back to resultsMulti-center Clinical Study on Neonatal Hyperbilirubinemia
Primary Purpose
Quality Improvement, Hyperbilirubinemia, Neonatal
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Quality improvement of management of neonatal jaundice
Sponsored by
About this trial
This is an interventional health services research trial for Quality Improvement focused on measuring Quality improvement, Hyperbilirubinemia, screening, follow-up
Eligibility Criteria
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.
Sites / Locations
- Nanjing Maternity and Child Health Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Before-intervention phase
Intervention phase
Sustainability intervention phase
Arm Description
All the healthy infants who were admitted from March 2018 to August 2018 to the Well Baby nurse of different hospitals.
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.
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.
Outcomes
Primary Outcome Measures
The incidence of bilirubin encephalopathy
Secondary Outcome Measures
The incidence of severe hyperbilirubinemia
Severe hyperbilirubinemia:total serum bilirubin more than 20mg/dL
The rate of lost to follow-up
The rate of lost to follow-up for jaundice after discharge from well-baby nursery
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
Medical costs in patients with severe hyperbilirubinemia
To compare the medical costs in patients with severe hyperbilirubinemia from 3 phases of quality improvement.
Full Information
NCT ID
NCT03824990
First Posted
January 30, 2019
Last Updated
October 29, 2021
Sponsor
Nanjing Medical University
Collaborators
JiLin Women and Children Health Hospital, Shandong Provincial Hospital, Shan Dong Qian Fo Shan Hospital, Shan Dong Liao Cheng Hospital, Guangxi Maternal and Child Health Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Yin Chuan Maternity and Child Health Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03824990
Brief Title
Multi-center Clinical Study on Neonatal Hyperbilirubinemia
Official Title
Multi-center Clinical Study on Early Screening and Treatment of Hyperbilirubinemia of Term and Late-preterm Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
Collaborators
JiLin Women and Children Health Hospital, Shandong Provincial Hospital, Shan Dong Qian Fo Shan Hospital, Shan Dong Liao Cheng Hospital, Guangxi Maternal and Child Health Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Yin Chuan Maternity and Child Health Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality Improvement, Hyperbilirubinemia, Neonatal
Keywords
Quality improvement, Hyperbilirubinemia, screening, follow-up
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Before-intervention phase
Arm Type
No Intervention
Arm Description
All the healthy infants who were admitted from March 2018 to August 2018 to the Well Baby nurse of different hospitals.
Arm Title
Intervention phase
Arm Type
Experimental
Arm 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.
Arm Title
Sustainability intervention phase
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Quality improvement of management of neonatal jaundice
Intervention Description
During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.
Primary Outcome Measure Information:
Title
The incidence of bilirubin encephalopathy
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The incidence of severe hyperbilirubinemia
Description
Severe hyperbilirubinemia:total serum bilirubin more than 20mg/dL
Time Frame
18 months
Title
The rate of lost to follow-up
Description
The rate of lost to follow-up for jaundice after discharge from well-baby nursery
Time Frame
18 months
Title
The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia
Description
Patients with severe hyperbilirubinemia from 11 hospitals will be followed to investigate their neurological outcomes until 24 months after birth
Time Frame
42 months
Title
Medical costs in patients with severe hyperbilirubinemia
Description
To compare the medical costs in patients with severe hyperbilirubinemia from 3 phases of quality improvement.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuping Han, PHD
Organizational Affiliation
Nanjing Maternity and Child Health Care Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zhangbin Yu, PHD
Organizational Affiliation
Nanjing Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhiyong Sun, PHD
Organizational Affiliation
JiLin Women and Children Health Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haiyan Cai, PHD
Organizational Affiliation
Qinhuangdao Maternal and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yonghui Yu, MD
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Yuan, MD
Organizational Affiliation
Shan Dong Qian Fo Shan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Qian, MD
Organizational Affiliation
Shan Dong Liao Cheng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jimei Wang, PHD
Organizational Affiliation
Obstetrics & Gynecology Hospital of Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenyan Tang, PHD
Organizational Affiliation
Jiangxi Maternal and Child Health Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qiufen Wei, PHD
Organizational Affiliation
Guangxi Maternal and Child Health Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhankui Li, PHD
Organizational Affiliation
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jie Gu, PHD
Organizational Affiliation
Yin Chuan Maternity and Child Health Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Maternity and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Multi-center Clinical Study on Neonatal Hyperbilirubinemia
We'll reach out to this number within 24 hrs