Clinical trials: Perinatal Hypoxia
Fetal Heart Rate Abnormalities, Respiratory Depression
Safer Births - Reducing Perinatal Mortality
Safer Births is a research and development collaboration to establish new knowledge and new innovative products to better equip and increase competence of health workers for safer births and increased newborn survival worldwide.
- Conditions
- Fetal Heart Rate Abnormalities, Respiratory Depression, Birth Asphyxia, Neonatal Resuscitation
- Trial name
- NCT01869582
- Testing
- Fetoscope, Fetal heart rate, Upright Resuscitator, Resuscitation, Doppler, Fetal heart rate
- Where
- 2 sites in Tanzania
- Volunteers
- 20,000 people
- Sponsor
- Helse Stavanger HF
Hypoxic Ischaemic Encephalopathy
Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy
The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in Switzerland who were admitted to the neonatal and intensive care units offering…
- Trial name
- NCT02800018
- Testing
- risk factors
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Children's Hospital, Zurich
Perinatal Death, Respiratory Distress Syndrome, Newborn
Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities
Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice.
- Conditions
- Perinatal Death, Respiratory Distress Syndrome, Newborn, Hypoxic-Ischemic Encephalopathy, Neonatal Seizure
- Trial name
- NCT03996317
- Testing
- Room air
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Loma Linda University
Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2
This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia, Hypocapnia
- Trial name
- HENRIC (NCT02700854)
- Testing
- 5% carbon-dioxide inhalation
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
Perinatal Asphyxia
A Study of 2-Iminobiotin in Neonates With Perinatal Asphyxia
In case of insufficient oxygen supply to the brain of a newborn child (perinatal asphyxia), toxic compounds will be formed. These toxic compounds will damage the cells of the brain.
- Trial name
- NCT01626924
- Testing
- 2-Iminobiotin
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 6 people
- Sponsor
- Neurophyxia B.V.
Infant, Newborn, Hypoxia, Brain
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01192776
- Testing
- Whole-body Cooling
- Where
- 19 sites in United States
- Volunteers
- 364 people
- Sponsor
- NICHD Neonatal Research Network
Mild Birth Asphyxia, Moderate Birth Asphyxia
Olfactory Testing in Perinatal Asphyxia: Enhancing Risk Assessment
Neonatal asphyxia remains a leading cause of neurodevelopmental disabilities despite advancements in perinatal care. Hypoxic-ischemic encephalopathy (HIE), a severe outcome of asphyxia, impacts 1-3 infants per 1,000 live births…
- Trial name
- MEMOBRAIN (NCT06744244)
- Testing
- Olfactory Testing, Heart rate (HR), Heart Rate Variability (HRV), Respiratory Rate (RR), peripheral oxygen saturation (SpO2), Video-EEG
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Parma
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy
The HIEnome Study: Genome Sequencing for Perinatal HIE
Perinatal hypoxic-ischemic encephalopathy is a rare severe condition in which neonates present with encephalopathy and a clinical history suggestive of prenatal or perinatal hypoxic-ischemic injury.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy, Hypoxic Ischemic Encephalopathy (HIE)
- Trial name
- NCT06762795
- Testing
- Genome sequencing
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor College of Medicine
Infant, Newborn, Hypoxia-Ischemia, Brain
Whole-Body Cooling for Birth Asphyxia in Term Infants
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected…
- Trial name
- NCT00005772
- Testing
- Induced hypothermia, Control
- Where
- 16 sites in United States
- Volunteers
- 208 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth
Metformin Treatment in Infants After Perinatal Brain Injury
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
- Trial name
- NCT05590676
- Testing
- Metformin Hydrochloride
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- The Hospital for Sick Children
HIE - Perinatal Hypoxic - Ischemic Encephalopathy
NVD in Hypothermic HIE Neonates
Neonatal hypoxic ischemic (HI) injury is an unpredictable neurologic injury with devastating, long term consequences for parents who are expecting a normal child.
- Trial name
- NCT04643821
- Testing
- N-acetylcysteine, NAC, and calcitriol
- Volunteers
- 30 people
- Sponsor
- Medical University of South Carolina
HIE - Perinatal Hypoxic - Ischemic Encephalopathy
The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy.
- Trial name
- NCT03835039
- Testing
- NIRS
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Albany Medical College
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth.
- Trial name
- SiSTEM-NEO (NCT07018739)
- Testing
- Wharton's jelly-derived mesenchymal stem cells, 0.9 % Normal Saline
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol 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
Seizures
Pilot Study of Bumetanide for Newborn Seizures
The main goal of the study is to obtain pharmacokinetic and safety data of bumetanide in newborns with refractory seizures. The overall hypothesis is that bumetanide, added to conventional antiepileptic (antiseizure) medications…
- Trial name
- NCT00830531
- Testing
- Bumetanide
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Soul, Janet , M.D.
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