Hyperbilirubinemia, Neonatal
Conditions
Keywords
Hyperbilirubinemia, Neonatal, Transcutaneous Bilirubin
Brief summary
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.
Detailed description
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.
Interventions
Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)
Sponsors
Children's Hospital of Fudan University
Nanjing Maternity and Child Health Care Hospital
First Affiliated Hospital of Harbin Medical University
Jinlin Provincial Maternal and Child Health Hospital
Peking University Third Hospital
Inner Mongolia Maternal and Child Health Care Hospital
Shanxi Provincial Maternity and Children's Hospital
Obstetrics & Gynecology Hospital of Fudan University
The First Affiliated Hospital of Zhengzhou University
Guangdong Women and Children Hospital
Guangxi Maternal and Child Health Hospital
First Affiliated Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
Guiyang Maternity and Child Health Care Hospital
Nanjing Medical University
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
| Measure | Time frame | Description |
|---|---|---|
| Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth | 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
| Measure | Time frame | Description |
|---|---|---|
| Predictive ability of an hour-specific TcB nomogram | 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. |
Countries
China
Outcome results
None listed