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The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Multicenter Prospective Study on the Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01762189
Enrollment
13157
Registered
2013-01-07
Start date
2013-01-31
Completion date
2013-12-31
Last updated
2014-10-28

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

Conditions

Hyperbilirubinemia, Neonatal

Keywords

Hyperbilirubinemia, Neonatal, Incidence, Risk factors

Brief summary

Thirteen hospitals in China will participate in the study, which aims to provide data on serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes. We hypothesize that the study can be value in identifying and implementing strategies for risk reduction.

Detailed description

Neonatal hyperbilirubinemia resulting in clinical jaundice is a common problem among infants, particularly during the first weeks of life. Information about the incidence and risk factors of neonatal jaundice is not available from China where is one of the highest countries of the incidence of severe neonatal hyperbilirubinemia.

Interventions

PROCEDUREPhototherapy

The decision to use phototherapy conformed to the hour-specific threshold value for phototherapy presented by the American Academy of Pediatrics guidelines and was not at the discretion of the investigators.

Sponsors

Children's Hospital of Fudan University
CollaboratorOTHER
Nanjing Maternity and Child Health Care Hospital
CollaboratorOTHER
Jinlin Provincial Maternal and Child Health Hospital
CollaboratorUNKNOWN
Peking University Third Hospital
CollaboratorOTHER
Inner Mongolia Maternal and Child Health Care Hospital
CollaboratorOTHER
Shanxi Provincial Maternity and Children's Hospital
CollaboratorOTHER
Obstetrics & Gynecology Hospital of Fudan University
CollaboratorOTHER
Guangdong Women and Children Hospital
CollaboratorOTHER
Guangxi Maternal and Child Health Hospital
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
First Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
Sichuan Provincial People's Hospital
CollaboratorOTHER
Guiyang Maternity and Child Health Care Hospital
CollaboratorOTHER
Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

Inclusion criteria

Term or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included.

Exclusion criteria

All sick newborn infants who were admitted to the intensive care unit.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of severe neonatal hyperbilirubinemiaAt the 28 days after birthSignificant hyperbilirubinemia was defined as any TSB level that exceeded the hour-specific threshold value for phototherapy, according to the guidelines presented by the American Academy of Pediatrics.

Secondary

MeasureTime frameDescription
Number of participants with risk factors associated with severe neonatal hyperbilirubinemiaAt the 28 days after birthThe risk factors recognized to be associated with significant hyperbilirubinemia in newborns have included gestational age, weight for Gestational Age, delivery mode, gender, previous infant had phototherapy, bruising/cephalahematoma, feeding mode, excessive body weight loss, and early discharge, et al.

Countries

China

Outcome results

None listed

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