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PI Name Protocol Number Protocol Title Status Approval Date
ANN STARK
H-16602 MULTICENTER OBSERVATIONAL STUDY TO EVALUATE STRATEGIES TO IDENTIFY INFANTS AT RISK FOR SEVERE HYPERBILIRUBINEMIA AFTER BIRTH HOSPITALIZATION AND PROMOTE A SAFE OUTCOME FOR NEONATAL JAUNDICE Approved 9/22/2006

 

Funding Source

Other:  Health Resources and Service Administration (HRSA) and Respironics, Inc

Background Info

Sixty percent of otherwise healthy newborns have clinical jaundice associated with increased concentration of total serum bilirubin (TSB). The outcome for the majority is benign, but infants with untreated extremely high TSB levels can develop kernicterus, a neurologically devastating condition thought to be due to bilirubin toxicity. TSB levels typically peak at age 3 to 5 days, usually after routine hospital discharge. Assessment before discharge of the risk for subsequent hyperbilirubinemia should facilitate appropriate follow-up and management. However, the most effective strategy to assess this risk is unknown.

Purpose and Objectives

The purpose of our study is to identify the most effective pre-discharge assessment for risk of subsequent hyperbilirubinemia. Specifically, we plan to test the following hypotheses in a racially diverse population of term and near-term newborn infants: (1) the pre-discharge (age <72 hours) bilirubin risk zone plotted on an hour-specific nomogram will more accurately predict significant hyperbilirubinemia than the use of clinical risk factors alone, and (2) the combined use of pre-discharge bilirubin risk zone and clinical risk factors will more accurately predict significant hyperbilirubinemia than using either method alone.

Design

 

Potential Risks

Participation in this study has no more than minimal risk or discomfort for the infant or mother. Use of the BiliCheck device has no associated risks or discomfort. If the transcutaneous bilirubin measurement (TcB) is high, the infant's clinician will measure a serum bilirubin level to see if treatment is needed. The TcB measurement will add about 5 minutes to the infant's clinic visit and the telephone call at 30 days of age will take about 10 minutes.

Potential Benefits

 

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