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Hypoxic-ischemic Encephalopathy clinical trials

View clinical trials related to Hypoxic-ischemic Encephalopathy.

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NCT ID: NCT03071783 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance

SVEA
Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates. By randomization, half of the vacuum extraction patients will be assigned to delivery using a new intelligent handle for vacuum extractions, and half will be assigned to conventional method without traction force measurement.

NCT ID: NCT03024021 Completed - Cardiac Arrest Clinical Trials

Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

Start date: September 2016
Phase:
Study type: Observational

This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest

NCT ID: NCT02826941 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Start date: June 1999
Phase: Phase 2
Study type: Interventional

This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.

NCT ID: NCT02700828 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns

CORTISoL
Start date: February 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed. The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency that may contribute to hypotension and lower efficacy of inotropic therapy in this patient population. Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation besides conventional inotropic therapy in a placebo-controlled fashion.

NCT ID: NCT02683915 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Reno-protective Effect of Brain Cooling in Newborn With Hypoxia

Start date: September 2015
Phase:
Study type: Observational

This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of serum(s) neutrophil gelatinase-associated lipocalin(NGAL) and serum (s) cystatin-C.

NCT ID: NCT02544542 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Clinical Trial of a New Rectum Cooling System on Patients of Hypoxic-ischemic Brain Damage

Start date: January 2014
Phase: N/A
Study type: Interventional

This study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. Half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.

NCT ID: NCT02529202 Completed - Clinical trials for Hypoxic-ischemic Encephalopathy

Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia

Start date: March 2016
Phase: Phase 0
Study type: Interventional

The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic encephalopathy.

NCT ID: NCT02349672 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

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

Start date: March 2016
Phase:
Study type: Observational

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.

NCT ID: NCT02287077 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

Start date: December 2014
Phase: N/A
Study type: Interventional

The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.

NCT ID: NCT02264808 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Developmental Outcomes

Start date: November 2014
Phase:
Study type: Observational

Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.