Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)

NCT02349672 | Completed

• 1 other identifier: IRB201400671
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Hypoxic-ischemic encephalopathy (HIE) is a serious birth complication due to systemic asphyxia which occurs in about 20 of 1,000 full-term infants and nearly 60% of premature newborns. Between 10-60% of babies who exhibit HIE die during the newborn period and up to 25% of the HIE survivors have permanent neurodevelopmental handicaps in the form of cerebral palsy, mental retardation, learning disabilities, or epilepsy. HIE also has a significant financial impact on the health care system. In the state of Florida, the total cost for initial hospitalization is $161,000 per HIE patient admitted, but those costs don't take into account the life-long costs. Current monitoring and evaluation of HIE, outcome prediction, and efficacy of hypothermia treatment rely on a combination of a neurological exam, ultrasound, magnetic resonance imaging (MRI) and electroencephalography (EEG). However, these methods do a poor job in identifying non-responders to hypothermia. MRI requires transport of the neonate with a requisite 40-45 min scan, which is not appropriate for unstable neonates. Moreover, the amplitude integrated EEG (aEEG), a common bedside monitoring technique currently used in these patients to assess candidates and predict outcomes prior to hypothermia, can be adversely affected by hypothermia itself and the patient may not appear to improve until re-warming. Consequently, the development of a simple, inexpensive, non-invasive, rapid biochemical test is essential to identify candidates for therapeutic hypothermia, to distinguish responders from non-responders and to assess outcome. This research is the first step needed to treat neonates with HIE employing a personalized medical approach using serum proteins GFAP and UCH-L1 as biomarkers and by monitoring neonates responses to therapeutic hypothermia. These biomarkers will aid in the direct care by providing a rapid test to predict outcomes and select candidates who are likely to benefit from therapeutic hypothermia and gauge a response to the neuroprotective intervention.

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

HIE; Neonates

Outcome Measures

Primary Outcomes (1)

• Levels of UCH-L1 in blood

  Determining if UCH-L1 concentrations measured in neonates with HIE are significantly elevated as compared to controls. Evaluate serum biomarker concentrations from a cohort of neonatal HIE patients who are candidates for hypothermia. These samples will be compared to samples collected from the two cohorts of neonatal "control" subjects.

  72 hours

Secondary Outcomes (1)

• Levels of GFAP in blood

  72 hours

Study Arms (2)

Healthy Control

The healthy control group will have 500-800uL (less than 1 mL) of blood collected. This sample will be obtained at the same time that the neonate is already having a standard blood screenings drawn at 24 and 48 hours of life.

Procedure: blood sample

Clinical Control

The clinical control group will be healthy neonates that are being evaluated for jaundice, with multiple blood samples drawn between birth and 48 hours of life to monitor serum bilirubin. With these already scheduled lab draws, we will draw an additional 0.8-1 mL of blood.

Procedure: blood sample

Interventions

blood sample PROCEDURE

Blood will be collected to test for concentrations of UCH-L1 and GFAP.

Clinical Control; Healthy Control

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

neonates

You may qualify if:

• greater than 1.8 kg
• gestational age of 34 weeks or greater

You may not qualify if:

• less than 1.8 kg
• gestational age less than 34 weeks

Sponsors & Collaborators

• University of Florida: lead
• American Heart Association: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nicole R Copenhaver, RN

  Study nurse UF Neonatology

  STUDY CHAIR

• Melissa Huene, RN

  Study nurse UF Neonatology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 29, 2015
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 21, 2018

Record last verified: 2018-06

Locations

US (1)