Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants

Summary

Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the intent to prevent bilirubin neurotoxicity. A threshold-based relationship between a specific total bilirubin level and need for intervention has been elusive. This is most likely due to other biomarkers such as hemolysis, developmental maturation, concurrent illnesses, or even interventions, may impede bilirubin/albumin binding. The over-prescription of phototherapy has impacted clinical and family-centered care, and in the extreme preterm infants, it may have augmented their risk of mortality. Thus, the opportunity to individualize phototherapy in in order to reduce its use is unique. The investigators have assembled a transdisciplinary team to examine critical unanswered questions including the role of bilirubin binding capacity (BBC) of an individual during the first week of life in the context of clinical modifiers and antecedents for a domain of bilirubin-induced neurologic disorders, that includes neuro-anatomical, hearing, visual and developmental processing impairments. In this study, the investigator will evaluate two new innovative nanotechniques to quantify bilirubin load for the first time in the context of a clinical decision algorithm to identify those most at risk for any bilirubin-related neurotoxicity. The investigators anticipate that knowledge gained from this study will lead to ethically testable hypotheses to individualize the prescription of phototherapy.

Conditions

• Bilirubin-induced Neurologic Dysfunction
• Hyperbilirubinemia
• Kernicterus
• Infant, Premature
• Infant, Low Birth Weight

Interventions

DIAGNOSTIC_TEST

Bilirubin Binding Capacity

Research laboratory assay of bilirubin binding capacity

DIAGNOSTIC_TEST

End-tidal Carbon Monoxide

Noninvasive bedside test to measure exhaled end-tidal carbon monoxide levels for the detection of hemolysis

DIAGNOSTIC_TEST

Carboxyhemoglobin

Laboratory assay of carboxyhemoglobin levels for the detection of hemolysis

Sponsors & Collaborators

• Smith-Kettlewell Eye Research Institute

  collaborator OTHER

• Stanford University

  lead OTHER

Principal Investigators

• Vinod K Bhutani, MD · Stanford University

Eligibility

Min Age

24 Weeks

Max Age

34 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-02-01

Primary Completion

2018-08-31

Completion

2018-08-31

Countries

• United States

Study Locations