Clinical trials: Hypoxia Neonatal
Neonatal Acidemia and Hypoxia
Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00
Severe neonatal acidosis is an identified risk factor for neonatal encephalopathies and severe neurological sequelae such as cerebral palsy.
- Trial name
- RCFHypA (NCT07333599)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- University Hospital, Strasbourg, France
Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia
Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia, Neonatal Encephalopathy
- Trial name
- NCT05514340
- Testing
- Normal Saline along with standard treatment, Sovateltide along with standard treatment
- Where
- 4 sites in India
- Volunteers
- 40 people
- Sponsor
- Pharmazz, Inc.
Neonatal Seizures
Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study
LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam.
- Trial name
- LEVNEONAT-1 (NCT02229123)
- Testing
- Intravenous Levetiracetam
- Where
- 8 sites in France
- Volunteers
- 18 people
- Sponsor
- University Hospital, Tours
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
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries.
- Trial name
- CVI (NCT07275021)
- Testing
- Prospective Clinical and Neurodevelopmental Data Collection
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Nephroprotection Following Perinatal Asphyxia: Randomized Controlled Trial
The aim of this study is to determine the value of Pentoxifylline for nephroprotection in these neonates with perinatal asphyxia, using cystatin C, regional oxygenation measured near infrared spectroscopy and renal Doppler…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Pentoxifylline Adverse Reaction
- Trial name
- NCT07088328
- Testing
- Pentoxifylline
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Periventricular Leukomalacia, White Matter Disease
Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain.
- Conditions
- Periventricular Leukomalacia, White Matter Disease, Hypoxic-Ischemic Encephalopathy, Demyelinating Diseases
- Trial name
- NCT06985303
- Testing
- Investigational Combination Product
- Sponsor
- MGAM LLC
Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn
Feasibility and Safety of Intranasally Administered Breast Milk in HIE
This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- F-NEO-BRIGHT (NCT06747260)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
About ~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process.
- Conditions
- Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
- Trial name
- COOL-SED (NCT06985290)
- Testing
- Dexmedetomidine Infusion, Morphine Infusion
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Ipsita Goswami
Maternal Obesity, Hypoxia Neonatal
Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.
Offspring from overweight or obese mothers appear to be at up to 38% increased risk of being admitted to the neonatal intensive care unit than the offspring of mothers with a normal BMI.
- Trial name
- NCT06917833
- Testing
- compare infant hypoxic events in both groups
- Volunteers
- 544 people
- Sponsor
- Ain Shams University
Altitude Hypoxia, Neonatal Encephalopathy
Neonatal Electrical Activity at Different Altitude Levels
In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and establish reference value…
- Trial name
- NCT05966714
- Testing
- aEEG
- Where
- 2 sites in China
- Volunteers
- 531 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Fudan University
Fetal Hypoxia, Fetal Distress
Trans-abdominal Fetal Pulse Oximetry
The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy.
- Conditions
- Fetal Hypoxia, Fetal Distress, Fetal Acidemia, Fetal or Neonatal Effect of Complication of Labor
- Trial name
- NCT05147584
- Testing
- Dual fetal oxygen sensors
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Hypoxic-Ischemic Encephalopathy, Brain Injury
Prospective Research in Infants With Mild Encephalopathy
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
- Trial name
- PRIME (NCT01747863)
- Testing
- Neurologic examination
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 63 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy
Intranasal Breast Milk Therapy in HIE
This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Perinatal Asphyxia, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- NEO-BRIGHT (NCT06746532)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 80 people
- Sponsor
- Semmelweis University
Hypoxia Ischemia, Cerebral, Hypoxia-Ischemia, Brain
Functional Imaging of Baby Brains
Infants are at risk of developing motor and cognitive neurodevelopmental disabilities as a sequelae to hypoxic-ischemic brain injury during the perinatal period.
- Conditions
- Hypoxia Ischemia, Cerebral, Hypoxia-Ischemia, Brain, Hypoxia Neonatal, Hypoxic-Ischemic Encephalopathy
- Trial name
- FIBB (NCT05514665)
- Testing
- Diffuse Optical Tomography
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Hamilton Health Sciences Corporation
Neonatal Hypoxic Ischemic Encephalopathy
Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.
- Trial name
- NCT00593242
- Testing
- infusion of autologous cord blood, Neurodevelopmental outcomes
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Michael Cotten
Neonatal Encephalopathy, Asphyxia Neonatorum
Heart Beat Variability in Neonatal Encephalopathy
This study will find out if analysing heartbeat in babies with brain injury, based on standard clinical monitors, can inform treatment decisions and monitor stress levels in real time
- Conditions
- Neonatal Encephalopathy, Asphyxia Neonatorum, Hypoxic-Ischemic Encephalopathy
- Trial name
- HeartBeat (NCT03179553)
- Where
- 5 sites in United Kingdom
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy
Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
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…
- Conditions
- Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy, Stillbirth, Admission to Neonatal Unit
- Trial name
- ULOOP (NCT05901688)
- Testing
- Umbilical cord measurements & observations
- Where
- United Kingdom
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Medway NHS Foundation Trust
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
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
There have been many studies on the use of running training in older children to improve gait development in children with cerebral palsy.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage Neonatal, Bilirubin Encephalopathy
- Trial name
- NCT03534466
- Testing
- Baby treadmill, Conventional physical rehabilitation training
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Children's Hospital of Fudan University