Clinical trials: Asphyxia Neonatorum
Asphyxia Neonatorum, Hypoxia
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.
- Conditions
- Asphyxia Neonatorum, Hypoxia, Encephalopathy, Seizures
- Trial name
- NCT00147030
- Testing
- Whole body mild induced hypothermia
- Where
- United Kingdom
- Volunteers
- 325 people
- Sponsor
- Imperial College London
Duration of Hospitalization, Neonatal Mortality Rate
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Neonatal asphyxia causes significant global morbidity, frequently resulting in Hypoxic-Ischemic Encephalopathy (HIE). In resource-limited settings where therapeutic hypothermia is unavailable, affordable neuroprotective options…
- Trial name
- NCT07835529
- Testing
- Magnesium sulphate, Supportive care and standard neonatal intensive care unit care
- Volunteers
- 72 people
- Sponsor
- Sargodha Medical College
Asphyxia Neonatorum
Resident Training Enhanced by New Innovations: Teleintubation
The overall goal of this study was to create a simulation environment with repeated practice for residents and intense, immediate feedback.
- Trial name
- NCT02572427
- Testing
- Education for intubation skills, No added education for intubation skills
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
Asphyxia Neonatorum
Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"
The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24…
- Trial name
- NCT03284528
- Testing
- hypothermia therapy
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- University Children's Hospital, Zurich
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping…
- Trial name
- CORDMILK (NCT03657394)
- Testing
- Umbilical cord milking
- Where
- 9 sites in India
- Volunteers
- 3,442 people
- Sponsor
- Nemours Children's Clinic
Fetal Distress, Birth Asphyxia
Effect of Intrapartum Oxygen Administration on Fetal and Early Neonatal Outcomes
Introduction Birth asphyxia is one of leading causes of neonatal mortality in Uganda. It is associated with long term neuro-developmental complications among the babies that survive.
- Trial name
- Intra-O (NCT04043299)
- Testing
- 100% Oxygen, 21% oxygen
- Where
- Uganda
- Volunteers
- 1,108 people
- Sponsor
- Makerere University
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
Neonatal Encephalopathy, Cell Damage
Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births.
- Conditions
- Neonatal Encephalopathy, Cell Damage, Metabolic Acidosis, Inflammation
- Trial name
- AGAIN (NCT03897101)
- Where
- 2 sites in Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University Hospital of Ferrara
Encephalopathy, Asphyxia Newborns
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.
- Trial name
- NCT02445417
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Sharp HealthCare
Neonatal Complication, Neonatal Asphyxia
Face Mask vs Laryngeal Mask in Neonatal Resuscitation
The goal of this single-centre interventional study without medication neither device (for procedure) is to improve training of health care personnel (physicians, nurses, and midwives) on neonatal resuscitation through manikin…
- Trial name
- ManiMask2025 (NCT06952088)
- Testing
- Training on Neonatal Resuscitation
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
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
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during…
- Conditions
- IVH- Intraventricular Hemorrhage, Extreme Prematurity, Hypoxia Neonatal, Hyperoxia
- Trial name
- DOXIE (NCT04413097)
- Testing
- Delayed Cord Clamping with Low Oxygen concentration, Delayed Cord Clamping with High Oxygen concentration
- Where
- 3 sites in United States
- Volunteers
- 140 people
- Sponsor
- Sharp HealthCare
Birth Asphyxia With Neurologic Involvement
Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping
3 clinical sites enrolling in the primary MINVI trial (NCT03631940) will collect Near Infrared Spectroscopy (NIRS) data in the first 10 minutes of life on a subset of 200 non-vigorous term and near-term infants enrolled in the…
- Trial name
- MINVINIRS (NCT03621956)
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- 3 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Sharp HealthCare
Fetal Distress, Stillbirth
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the intermittent auscultation protocols at KCMC, and to…
- Conditions
- Fetal Distress, Stillbirth, Birth Asphyxia, Acidosis
- Trial name
- NCT02862925
- Testing
- Fetal Scalp Stimulation
- Where
- Tanzania
- Volunteers
- 550 people
- Sponsor
- Duke University
Neonatal Encephalopathy
CoolCap Followup Study-Coordination of Participating Centers
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial.
- Trial name
- NCT00581581
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Rochester
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.
Hypoxic Ischemic Encephalopathy
Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia
The purpose of this study is to determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of treatment with hypothermia.
- Trial name
- NeoNATI (NCT01241019)
- Testing
- Topiramate in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia
- Where
- 2 sites in Italy
- Volunteers
- 64 people
- Sponsor
- Meyer Children's Hospital IRCCS
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE.
- Trial name
- NCT07897032
- Testing
- Levetiracetam, Therapeutic hypothermia (whole body cooling)
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Alexandria University