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NCT Number: NCT01762189

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

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.

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Key information

Conditions

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

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Maternal and Children's Hospital, Guangzhou Medical College, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Phototherapy

Procedure

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.

Primary outcomes

  1. The incidence of severe neonatal hyperbilirubinemia

    Time frame: At the 28 days after birth

    Significant 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 outcomes

  1. Number of participants with risk factors associated with severe neonatal hyperbilirubinemia

    Time frame: At the 28 days after birth

    The 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.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2013
Registry last updated
Oct 28, 2014

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.

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