NCT03824990

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

3.5 years

First QC Date

January 30, 2019

Last Update Submit

October 29, 2021

Conditions

Quality ImprovementHyperbilirubinemia, Neonatal

Keywords

Quality improvementHyperbilirubinemiascreeningfollow-up

Outcome Measures

Primary Outcomes (1)

  • The incidence of bilirubin encephalopathy

    18 months

Secondary Outcomes (4)

  • The incidence of severe hyperbilirubinemia

    18 months

  • The rate of lost to follow-up

    18 months

  • The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia

    42 months

  • Medical costs in patients with severe hyperbilirubinemia

    18 months

Study Arms (3)

Before-intervention phase

NO INTERVENTION

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

Intervention phase

EXPERIMENTAL

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

Sustainability intervention phase

EXPERIMENTAL

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

Interventions

Quality improvement of management of neonatal jaundiceBEHAVIORAL

During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.

Intervention phaseSustainability intervention phase

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • term or near-term neonates with gestational age ≥35w and birth weight ≥2000g.

You may not qualify if:

  • Infants admitted to a higher level of intervention before discharge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Hyperbilirubinemia, NeonatalHyperbilirubinemia

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shuping Han, PHD

    Nanjing Maternity and Child Health Care Hospital

    STUDY DIRECTOR

  • Zhangbin Yu, PHD

    Nanjing Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Zhiyong Sun, PHD

    JiLin Women and Children Health Hospital

    PRINCIPAL INVESTIGATOR

  • Haiyan Cai, PHD

    Qinhuangdao Maternal and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Yonghui Yu, MD

    Shandong Provincial Hospital

    PRINCIPAL INVESTIGATOR

  • Xin Yuan, MD

    Shan Dong Qian Fo Shan Hospital

    PRINCIPAL INVESTIGATOR

  • Jin Qian, MD

    Shan Dong Liao Cheng Hospital

    PRINCIPAL INVESTIGATOR

  • Jimei Wang, PHD

    Obstetrics & Gynecology Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

  • Wenyan Tang, PHD

    Jiangxi Maternal and Child Health Hospital

    PRINCIPAL INVESTIGATOR

  • Qiufen Wei, PHD

    Guangxi Maternal and Child Health Hospital

    PRINCIPAL INVESTIGATOR

  • Zhankui Li, PHD

    Northwest Women's and Children's Hospital, Xi'an, Shaanxi

    PRINCIPAL INVESTIGATOR

  • Jie Gu, PHD

    Yin Chuan Maternity and Child Health Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nan Jing Maternity and Child Health Care Hospital

Study Record Dates

First Submitted

January 30, 2019

First Posted

January 31, 2019

Study Start

March 1, 2018

Primary Completion

August 31, 2021

Study Completion

October 15, 2021

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

CN(1)