Clinical trials: Hypoxic-Ischemic Encephalopathy, Neonatal
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
The purpose of this study is to evaluate the feasibility and begin to evaluate the effect of a sensorimotor intervention (SMI) provided in the first 6 months of life for infants with hypoxic-ischemic encephalopathy.
- Trial name
- NCT05130528
- Testing
- Sensorimotor Intervention
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Southern California
Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury
Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia
This prospective, single-center observational cohort study evaluated whether continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring during therapeutic hypothermia distinguishes term neonates with…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Neonatal, Asphyxia Neonatorum
- Trial name
- NCT07743099
- Testing
- 1- Continuous Cerebral Near-Infrared Spectroscopy, 2- Continuous Bilateral Renal Near-Infrared Spectroscopy
- Where
- Turkey (Türkiye)
- Volunteers
- 46 people
- Sponsor
- Agah Bahadır Öztürk,MD
Hypoxic Ischemic Encephalopathy
Autologous Cord Blood Cells for Brain Injury in Term Newborns
This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury.
- Trial name
- NCT01649648
- Testing
- Autologous cord blood
- Where
- 3 sites in Singapore
- Volunteers
- 2 people
- Sponsor
- National University Hospital, Singapore
Hypoxic-Ischemic Encephalopathy
School-aged Outcomes Post Hypoxic Ischaemic Encephalopathy
Neonatal HIE increases the risk for cognitive impairments in childhood. Neonatal MRI brain scans are a strong predictor for outcome, however a normal scan has only a 35% sensitivity and 85% specificity for a normal outcome.
- Trial name
- SOPHIE (NCT07770035)
- Where
- Ireland
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- University College Cork
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill
There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage, Bilirubin Encephalopathy
- Trial name
- NCT03527498
- Testing
- Baby treadmill, Physical rehabilitation training
- Where
- China
- Sponsor
- Children's Hospital of Fudan University
Birth Asphyxia
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.
- Trial name
- CEBA (NCT01743742)
- Testing
- Vitamin E, Vitamin C
- Where
- India
- Volunteers
- 95 people
- Sponsor
- Sir Takhtasinhji General Hospital
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Asphyxia Neonatorum
Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.
- Trial name
- AAMBI (NCT03354208)
- Testing
- blood sampling
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Life Science Inkubator
Hypoxic Ischemic Encephalopathy
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
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.
- Trial name
- NCT02349672
- Testing
- blood sample
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of Florida
Hypoxic-ischemic Encephalopathy
Neonatal Erythropoietin in Asphyxiated Term Newborns
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
- Trial name
- NEAT (NCT00719407)
- Testing
- erythropoietin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of California, San Francisco
Hypoxic-Ischemic Encephalopathy, Congenital Heart Disease
Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit
The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Congenital Heart Disease, Stroke Hemorrhagic, Aneurysm Cerebral
- Trial name
- NCT07732244
- Testing
- Wireless NIRS
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Neonatal Hypoxic Ischemic Encephalopathy
Antenatal and Intrapartum Risk Factors Associated With Neonatal Hypoxic Ischemic Encephalopathy
Perinatal asphyxia is a major cause of hypoxic Ischemic encephalopathy (HIE), perinatal death and long term neurodisability. This can be devastating for the individual and their family; the healthcare and litigation costs…
- Trial name
- NCT04364932
- Volunteers
- 100 people
- Sponsor
- Assiut University
Hypoxic-ischemic Encephalopathy (HIE)
The PROTECT-HIE Pilot Trial
Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart.
- Trial name
- PROTECT-HIE (NCT07406477)
- Testing
- Dobutamine, TnECHO
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Alberta
Hypoxia-Ischemia, Brain, Periventricular Leukomalacia
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
The investigators propose to compare the proteomic analysis of umbilical venous blood from neonates with brain injury to gestational age matched noninjured controls.
- Trial name
- NCT00375908
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Johns Hopkins University
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Circulatory Failure
NeoAdapt 3: Novel Biomarkers in the Evaluation of Neonatal Circulatory Insufficiency in Babies Suffering From Hypoxic Ischemic Encephalopathy
1 in 1000 babies are born suffering from a lack of oxygen. This is known as hypoxic ischemic encephalopathy (HIE). Infants with this condition can suffer multiple organ problems.
- Trial name
- NCT02051894
- Testing
- Dobutamine
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- Brighton and Sussex University Hospitals NHS Trust
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries.
- Trial name
- NCT02793999
- Testing
- Near-Infrared Spectroscopy (NIRS)
- Where
- 3 sites in United States
- Volunteers
- 125 people
- Sponsor
- Boston Children's Hospital
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment.
- Trial name
- NCT03837717
- Testing
- Holding, Saliva collection, No Holding
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- MaineHealth
Hypoxic-ischemic Encephalopathy
Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia
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.
- Trial name
- NCT02529202
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Seattle Children's Hospital
Hypothermia
Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy
Controlled Hypothermia has become the standard of care for neonates with moderate to severe HIE. Ampicillin and aminoglycosides are drugs that are universally used for the treatment of suspected neonatal sepsis, which may or may…
- Trial name
- NCT03129620
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Drexel University