Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants

Study Type/Phase: Observational
Status: Not Recruiting

Both term and preterm infants develop jaundice in the first couple of weeks of their life. Bilirubin (yellow – orange) pigments in the blood are responsible for jaundice. The bilirubin pigments can enter brain when the blood levels are high and cause injury to the developing brain cells. Injury to the developing preterm brain cell is more significant compared to the term brain cell. The rate of bilirubin entry to the brain is dependent on the amount of free or unbound bilirubin in the blood.

The purpose of this study is to measure the capacity of the baby’s blood to bind bilirubin, the yellow-orange compound responsible for causing jaundice in babies, as well as quantify the amount of carbon monoxide (CO) from the baby’s blood. This measure of CO represents an index of how much bilirubin he/she is producing. This study will help identify if these two measurements taken together can help detect which babies are most at risk for developing high bilirubin levels (hyperbilirubinemia). These at-risk babies require phototherapy to decrease their amount of bilirubin in their body and minimize the risk of brain damage.

Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the intent to prevent bilirubin neurotoxicity. The over-prescription of phototherapy has impacted clinical and family-centered care, and in extreme preterm infants, it may have augmented their risk of mortality. This study could help determine a new approach to provide personalized care to guide the use of phototherapy for jaundice.

Approximately 60-80 babies will be enrolled at the El Camino Hospital NICU.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Patients (GA 24 to ≤34 wks)
  • Major life-threatening anomalies and diagnosed inborn errors of metabolic disorders
  • Attending physician or parent refusal

Principal Investigator

Dharshi Sivakumar, MD

Sponsor

NIH Grant

NCT Number

NCT02691156

Contact

Martin Castillo Cuadrado, Research Coordinator
415-531-8778
martinc@stanford.edu

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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