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

Nanjing Medical University19,601 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

19,601

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Transcutaneous bilirubinometryDEVICE

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (16)

Guangdong Maternal and Children's Hospital, Guangzhou Medical College

Guangzhou, Guangdong, China

Guangxi Maternal and Child Health Hospital

Liuchow, Guangxi, China

Outcomes

Primary Outcomes

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

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.

Time frame: Every 12 hr for 168 hr.

Secondary Outcomes

Predictive ability of an hour-specific TcB nomogram

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.

Time frame: At the 28 days after birth

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.