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Multi-center Clinical Study on Neonatal Hyperbilirubinemia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03824990
Enrollment
20000
Registered
2019-01-31
Start date
2018-03-01
Completion date
2021-10-15
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia, Neonatal, Quality Improvement

Keywords

Quality improvement, Hyperbilirubinemia, screening, follow-up

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.

Interventions

BEHAVIORALQuality improvement of management of neonatal jaundice

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

Sponsors

JiLin Women and Children Health Hospital
CollaboratorUNKNOWN
Shandong Provincial Hospital
CollaboratorOTHER_GOV
Shan Dong Qian Fo Shan Hospital
CollaboratorUNKNOWN
Shan Dong Liao Cheng Hospital
CollaboratorUNKNOWN
Guangxi Maternal and Child Health Hospital
CollaboratorOTHER
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
CollaboratorOTHER
Yin Chuan Maternity and Child Health Hospital
CollaboratorUNKNOWN
Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The incidence of bilirubin encephalopathy18 months

Secondary

MeasureTime frameDescription
The incidence of severe hyperbilirubinemia18 monthsSevere hyperbilirubinemia:total serum bilirubin more than 20mg/dL
The rate of lost to follow-up18 monthsThe rate of lost to follow-up for jaundice after discharge from well-baby nursery
The incidence of adverse neurological outcomes in patients with severe hyperbilirubinemia42 monthsPatients 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 hyperbilirubinemia18 monthsTo compare the medical costs in patients with severe hyperbilirubinemia from 3 phases of quality improvement.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026