Implementation of a Clinical Decision Rule for Treatment of Neonatal Jaundice in the Emergency Department

Completed

Conditions studied: Hyperbilirubinemia

In brief

Jaundice is a condition caused by elevated levels of bilirubin in the body otherwise known as hyperbilirubinemia. It occurs when there is an increase in bilirubin production or normal production with problems eliminating it from the body. Serum levels of bilirubin in excess of 5 mg/dL signifies clinical jaundice, yet more than half of full term infants experience these levels within the first week of life. For those patients who have markedly elevated serum bilirubin levels, which phototherapy cannot sufficiently treat, the use of exchange transfusions is a viable option within the hospital setting. In comparison, bili-blankets have been used as a form of phototherapy for those patients being treated in a home-based setting to reduce the likelihood of hospital readmissions.

Key facts

Study ID

NCT02446951

Run by

Children's Hospitals and Clinics of Minnesota

People needed

925

Starts

2015-01-01

Expected to finish

2016-12-31

Last updated by the study team

2018-04-19

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients are birth to 7 days post-natal age
• Present in Minneapolis or St Paul ED during the pre-implementation or implementation period with a chief complaint of jaundice.

You may not qualify if…

• Children born prematurely
• Concern for sepsis or bacterial infection
• In-born error of metabolism
• Metabolic disease
• Positive newborn screen (e.g. Sickle Cell Disease, Cystic Fibrosis)

Where it is running

• Children's Hospital & Clinics of Minnesota — Minneapolis, Minnesota, United States
• Children's Hopsitals and Clinics of Minnesota — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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