Ignite Creation Date:
2024-05-06 @ 3:41 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02349672
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2015-01-23
Brief Title:
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy Control Levels
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy HIE Control Levels
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypoxic-ischemic encephalopathy HIE is a serious birth complication due to systemic asphyxia which occurs in about 20 of 1000 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 161000 per HIE patient admitted but those costs dont 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
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
Detailed Description:
Control Neonates will be easily obtained from a single center Shands UF The control samples will be derived from two groups 1 Healthy Controls will be healthy neonates with Apgar scores 7 at 1 minute and 8 at 5 minutes and no other medical problems associated with neurologic injury such as hyperbilirubinemia or hypoglycemia This group will establish a negative control and will have 500-800µL of blood collected at the time of standard blood metabolic screens at 24 and 48 hours of life 2 Clinical Controls will be healthy neonates evaluated for jaundice with multiple blood samples drawn between birth and 48 hours of life to monitor serum bilirubin concentrations They will have an additional 08-1 mL of blood drawn at the time of any clinical sample venous or heel stick is performed In addition neonates will be excluded if they show signs of sepsis or hypoglycemia 40 The neonates bilirubin will be plotted using the American Academy of Pediatrics risk-based stratification method the Bhutani monogram which is a based on the serum bilirubin concentration and the hours of life Clinical control neonates must have low-risk or low-intermediate bilirubin concentrations with virtually no risk of brain injury
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None