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

N

Nanjing Medical University

Status

Completed

Conditions

Hyperbilirubinemia, Neonatal

Treatments

Device: Transcutaneous bilirubinometry

Study type

Observational

Funder types

Other

Identifiers

NCT01763632
NMU-FY2012-318

Details and patient eligibility

About

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.

Full 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.

Enrollment

19,601 patients

Sex

All

Ages

1 to 28 days old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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