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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT02605018 Not yet recruiting - Cerebral Infarction Clinical Trials

Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy

Start date: November 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia,which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.

NCT ID: NCT02578823 Recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy

Targeted Temperature Management After In-Hospital Cardiac Arrest

TTM36-IHCA
Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether targeted temperature management at 36.0˚C(TTM-36) in patients who remain unconscious after resuscitation from in-hospital cardiac arrest(IHCA) will reduce death and disability compared with fever control. For this purpose, the current pilot study will be undertaken to establish the feasibility, safety, and surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain unconscious after resuscitation from IHCA. Eligible patients will be randomly assigned in a 2:1 ratio to either TTM-36(n=40) or conventional treatment group(n=20). Randomization will be performed with stratification according to initial rhythm (shockable vs. non-shockable).

NCT ID: NCT02551003 Withdrawn - Cerebral Infarction Clinical Trials

Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy

Start date: September 8, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.

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: NCT02455830 Active, not recruiting - Clinical trials for Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)

Cytokines Associated With Cord Blood Cell Therapy for Neonatal Encephalopathy

Start date: April 2015
Phase:
Study type: Observational

This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.

NCT ID: NCT02434965 Withdrawn - Clinical trials for Severe Hypoxic-ischemic Encephalopathy

Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy

HPDSC+HIE
Start date: December 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of autologous human placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates with severe 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.