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NCT Number: NCT01763632

Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants

Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram.

The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.

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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 is very common; it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe 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

Transcutaneous bilirubinometry

Device

Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)

Primary outcomes

  1. Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth

    Time frame: Every 12 hr for 168 hr.

    During the first postnatal day, transcutaneous bilirubin (TcB) measures were performed at 12-hour time intervals up to the age of 168 hr. TcB data are used to develop an hour-specific TcB nomogram.

Secondary outcomes

  1. Predictive ability of an hour-specific TcB nomogram

    Time frame: At the 28 days after birth

    Evaluate the rate of rise of bilirubin for different time periods and percentile curves and to assess predictive ability of these percentile curves for hyperbilirubinemia, defined as requirement of phototherapy.

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

Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 9, 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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