Skip to main content
OpenTrials
Completed

NCT Number: NCT03824990

Multi-center Clinical Study on Neonatal Hyperbilirubinemia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Quality Improvement Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality improvement of management of neonatal jaundice

Behavioral

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

Primary outcomes

  1. The incidence of bilirubin encephalopathy

    Time frame: 18 months

Secondary outcomes

  1. The incidence of severe hyperbilirubinemia

    Time frame: 18 months

    Severe hyperbilirubinemia:total serum bilirubin more than 20mg/dL

  2. The rate of lost to follow-up

    Time frame: 18 months

    The rate of lost to follow-up for jaundice after discharge from well-baby nursery

  3. The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia

    Time frame: 42 months

    Patients with severe hyperbilirubinemia from 11 hospitals will be followed to investigate their neurological outcomes until 24 months after birth

  4. Medical costs in patients with severe hyperbilirubinemia

    Time frame: 18 months

    To compare the medical costs in patients with severe hyperbilirubinemia from 3 phases of quality improvement.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • Guangxi Maternal and Child Health Hospital
  • JiLin Women and Children Health Hospital
  • Northwest Women's and Children's Hospital, Xi'an, Shaanxi
  • Shan Dong Liao Cheng Hospital
  • Shan Dong Qian Fo Shan Hospital
  • Shandong Provincial Hospital
  • Yin Chuan Maternity and Child Health Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.