Clinical trials: Asphyxia, open to volunteers
Neonatal Encephalopathy, Newborn Asphyxia
Cooling in Mild Encephalopathy
The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish…
- Trial name
- COMET (NCT05889507)
- Testing
- Whole body hypothermia, Targeted normothermia, Supportive neonatal intensive care
- Where
- 39 sites in Italy, United Kingdom
- Volunteers
- 426 people
- Sponsor
- Imperial College London
Perinatal Asphyxia, Hypothermia Treatment
Quantification of Brain and Kidney Perfusion Before, During, and After Hypothermia Treatment in Neonates With Perinatal Asphyxia Using Contrast-enhanced Ultrasound
In this clinical study vascular dynamics in the neonatal brain and kidney will be monitored by CUES and ULM before, during and after hypothermia treatment in neonates with asphyxia.
- Conditions
- Perinatal Asphyxia, Hypothermia Treatment, Gestational Age Min. 36SSW
- Trial name
- NCT06611254
- Testing
- Contrast enhanced ultrasound imaging (CEUS) and post processing with ULM
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Neonate, Asphyxia
Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying…
- Conditions
- Neonate, Asphyxia, EEG, Eye Tracking
- Trial name
- Neurobiom (NCT07702500)
- Testing
- EEG
- Where
- France
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
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
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
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
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia, Neonatal Brain Injury
- Trial name
- COOLDECIDE (NCT07764315)
- Volunteers
- 310 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
Newborn Asphyxia
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation.
- Trial name
- NCT06394453
- Testing
- enteral feeding with mother milk or human donor breast milk
- Where
- Poland
- Volunteers
- 104 people
- Sponsor
- Nutricia Foundation
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
Swiss Neonatal Network & Follow-up Group
The chief aim of the Swiss Neonatal Network \& Follow-Up Group (SwissNeoNet) is to maintain and / or improve the quality and safety of medical care for high-risk newborn infants and their families in Switzerland through a…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Asphyxia Neonatorum
- Trial name
- SwissNeoNet (NCT04239508)
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- Swiss Neonatal Network
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Early Virtual Intervention for Infants With CP Following HIE Diagnosis
This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental…
- Conditions
- Cerebral Palsy, Hypoxic-Ischemic Encephalopathy, Brain Injuries, Perinatal Hypoxia
- Trial name
- RECOVER (NCT04913324)
- Testing
- Virtual Care
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- The Hospital for Sick Children
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
Newborn Asphyxia, Hypothermia Neonatal
Effectiveness of Simulation-based Training Delivered to Special Newborn Care Providers on Resuscitation Management and Kangaroo Mother Care: Simulation-based Training for Asyphxia in Babies Trial (STAR-Baby Trial)
Summary Background Neonatal mortality remains a major global public health challenge, with about 2.4 million newborn deaths occurring within the first month of life in 2020.
- Trial name
- STAR-Baby (NCT07574944)
- Testing
- Simulation-based training using Neonatalie
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Integrated Development Foundation Nepal
Hypoxic-Ischemic Encephalopathy, Asphyxia
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Asphyxia, Hypotension, Circulatory Failure Neonatal
- Trial name
- UniCort (NCT05836610)
- Testing
- Hydrocortisone
- Where
- Hungary
- Volunteers
- 50 people
- Sponsor
- Semmelweis University
Neonatal Hypoxia
Citicoline as Neuroprotector in Neonates Exposed to Hypoxia
Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial
- Trial name
- NCT03949049
- Testing
- Citicoline
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Sherief Abd-Elsalam
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.
Sudden Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
Preterm, Patent Ductus Arteriosus
NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot
Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term/premature infants and sick neonates.
- Conditions
- Preterm, Patent Ductus Arteriosus, Sepsis, Asphyxia
- Trial name
- CE-NeoDoppler (NCT06646250)
- Testing
- NeoDoppler - CE certified
- Where
- Norway
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- St. Olavs Hospital
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