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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Procedure: Phototherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Phototherapy|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of severe neonatal hyperbilirubinemia | 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. | At the 28 days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with risk factors associated with severe neonatal hyperbilirubinemia | 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. | At the 28 days after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperbilirubinemia, Neonatal, Incidence, Risk factors