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Hypoxic-ischemic Encephalopathy clinical trials

View clinical trials related to Hypoxic-ischemic Encephalopathy.

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NCT ID: NCT06195345 Recruiting - Clinical trials for Hemodynamic Instability

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

ICHOR 1
Start date: November 1, 2018
Phase:
Study type: Observational

This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.

NCT ID: NCT06145256 Not yet recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy

Radiological Evaluation of Hypoxic Ischemic Encephalopathy

Start date: December 10, 2023
Phase:
Study type: Observational

To compare between Transcranial Ultrasound , MRI and CT in patients with Hypoxic Ischemic Encephalopathyas regards diagnostic accuracy and prognostic value .

NCT ID: NCT06090968 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation

Start date: February 5, 2022
Phase: N/A
Study type: Interventional

The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.

NCT ID: NCT05986994 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Identification of a Pool of miRNA to Improve Early Management of Perinatal Asphyxia and Hypoxic Ischemic Encephalopathy

Start date: July 18, 2023
Phase:
Study type: Observational

Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries. It is associated with a high rate of mortality and morbidity. Major neurological outcomes such as cerebral palsy, mental retardation, learning disabilities, epilepsy occur in approximately 25% of survivors. The diagnostic and prognostic tools currently available for enrollment have limitations and additional reliable biomarkers are needed for all phases of clinical management. Sarnat staging has taken on a role in identifying those infants who may benefit from treatment of hypothermia, resulting in the need for neurological evaluation and staging within 6 hours of life. Therapeutic hypothermia is still the best therapeutic treatment. A new tool in neuroscience research is represented by micro-ribonucleic acid (microRNA) profiling. The presence of microRNAs in blood, urine and saliva and the ability to measure their levels non-invasively has opened new doors in the search for peripheral biomarkers for the diagnosis and prognosis of neurodegenerative diseases and also as possible pharmacological targets. The aim of the present study is to analyze a specific cluster of miRNAs selected from data obtained by macroarray (NGS Pannel) on the entire microRNAome in healthy newborns with normal cord arterial pH value (7.26-7.35) as control cases and in newborns with fetal metabolic acidosis with a pH threshold value lower than 7.12 of the blood gas analysis from cord arterial blood. This latter group will be further stratified into two groups, neonates who will practice therapeutic hypothermia according to current guidelines and a further group who will not practice therapeutic hypothermia. This study will make a further international contribution in evaluating and identifying the potential of microRNAs as diagnostic and prognostic biomarkers in perinatal asphyxia and hypoxic ischemic encephalopathy. Furthermore, the study aims to identify specific microRNA sequences as new possible markers to be used as an additional parameter for the enrollment of therapeutic hypothermia, especially in cases of mild hypoxic-ischemic encephalopathy.

NCT ID: NCT05971446 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Healthy Little Eyes

Start date: February 24, 2020
Phase:
Study type: Observational

The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better diagnose and treat babies with hypoxic-ischemic encephalopathy (HIE). Participants will undergo up to two eye exam sessions, involving both Visual Evoked Potential (VEP) and Electroretinogram (ERG) exams.

NCT ID: NCT05901688 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes

ULOOP
Start date: October 3, 2023
Phase:
Study type: Observational

The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical cord coiling index (UCI), umbilical cord (UC) diameter, umbilical vein (UV) diameter, UV flow velocity and the presence of nuchal cord. The UCI, UC, UV diameter & flow and presence of nuchal cord will be measured in routine unselected populations at 20-22 weeks and 35-37 weeks gestation during the study period. We will also measure the UC and UV diameter in a nested population of high-risk pregnancies attending our placental disorders clinic which have been deemed to be at risk of having adverse pregnancy outcomes. Primary objective: To investigate if prenatal assessment of UCI, UC, UV diameter & flow and presence of nuchal cord measured routinely in unselected screened populations at 20-22 weeks and 35-37 weeks' can provide an independent prediction of pregnancies that develop adverse pregnancy outcomes. Secondary objectives: To assess the correlation of UC and UV diameter measured by ultrasound scan and fetal magnetic resonance imaging in prediction of pregnancy outcome. To examine the association of these umbilical cord measurements and observations in a nested cohort of pregnancies in the high-risk placental disorders clinic.

NCT ID: NCT05836610 Recruiting - Hypotension Clinical Trials

Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

UniCort
Start date: September 21, 2021
Phase: Phase 4
Study type: Interventional

This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to hydrocortisone supplementation while receiving conventional inotropic therapy as needed. The hypothesis is that a detailed study of hydrocortisone pharmacokinetics during therapeutic hypothermia would help to personalize steroid supplementation in asphyxiated neonates. As the overall metabolic rate decreases with lower body temperature, drug metabolism is likely to be reduced as well, and lower doses, or less frequent dosing will be sufficient to achieve the targeted steroid range and biological effects in asphyxiated neonates with relative adrenal insufficiency. Thus, the investigators are planning to measure initial, baseline serum cortisol levels and serial serum cortisol levels after hydrocortisone supplementation in cooled asphyxiated neonates.

NCT ID: NCT05787899 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Hypothermia's Effect on Hepatitis B Vaccination

Start date: May 18, 2023
Phase:
Study type: Observational

The purpose of the research is to determine if the Hepatitis B vaccine after birth provides enough protection after cooling for Hypoxic Ischemic Encephalopathy (HIE). To do this, Hepatitis B titers (blood sample) would be taken before, during, and after administering of the Hepatitis B vaccine series to measure efficacy of the vaccine.

NCT ID: NCT05778188 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

STAR
Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.

NCT ID: NCT05687708 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated. Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding. The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly. The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.