Clinical trials: Asphyxia
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
Infant, Premature, Diseases, Congenital Abnormalities
Esophageal Motility and Airway Defenses Among Infants
Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function.
- Conditions
- Infant, Premature, Diseases, Congenital Abnormalities, Perinatal Asphyxia
- Trial name
- NCT00062452
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Acute Kidney Injury
Acute Kidney Injury in Newborns With Perinatal Asphyxia
The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to…
- Trial name
- NCT03617055
- Testing
- serum cystatin c
- Volunteers
- 50 people
- Sponsor
- Assiut 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
Heart; Arrest, Newborn, Birth Asphyxia
Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC
When newborn babies are born without a heartbeat the clinical team has to provide breathing and chest compressions (what is call cardiopulmonary resuscitation) to the newborn baby.
- Conditions
- Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal
- Trial name
- SURV1VE-O2 (NCT03902652)
- Testing
- Intervention (21% oxygen during CC+SI), Intervention (100% oxygen during CC+SI)
- Where
- Canada
- Sponsor
- University of Alberta
Head Lice, Pediculosis Capitis
A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.
The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).
- Trial name
- NCT03617926
- Testing
- X92001666
- Where
- 2 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Oystershell NV
Swallowing Disorder, Perinatal Asphyxia
Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy…
- Conditions
- Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn, Feeding Disorder of Infancy or Early Childhood
- Trial name
- NCT05687708
- Testing
- Non-Nutritive Sucking
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Medipol University
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
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
Birth Asphyxia
Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia
The investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia.
- Trial name
- SANE-02 (NCT04169191)
- Testing
- Sildenafil Citrate
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Asphyxia Neonatorum, Birth Asphyxia
Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application
Some newborn babies have difficulty breathing at birth and need help. When babies need help with breathing the clinical team, the team measures heart rate using a stethoscope to check its heart rate and figure out what kind of…
- Trial name
- NCT03913533
- Testing
- Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method, Heart rate assessment using Tap-based smartphone application
- Where
- Canada
- Sponsor
- University of Alberta
Out-Of-Hospital Cardiac Arrest, Trauma
AI to Improve Data From Danish Cardiac Arrest Registry
Out-of-hospital cardiac arrest is a leading cause of death worldwide and patient outcome vary substantially throughout regions suggesting further evaluation and potential for improvement.When focussing on subgroups of OHCA, data…
- Conditions
- Out-Of-Hospital Cardiac Arrest, Trauma, Drug Overdose, Electrocution
- Trial name
- NCT05308303
- Where
- Denmark
- Volunteers
- 31,200 people
- Sponsor
- Prehospital Center, Region Zealand
Asphyxia Neonatorum
First Breath: Neonatal Resuscitation in Developing Countries
In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared…
- Trial name
- NCT00136708
- Testing
- Neonatal Resuscitation
- Where
- 7 sites in Argentina, Guatemala and 4 more
- Volunteers
- 120,009 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Hypoxia, in Liveborn Infant, Neonatal Asphyxia
Infant Special Program for In Hospital Resuscitation Education in the Delivery Room
The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn survival and neurologic outcomes.
- Conditions
- Hypoxia, in Liveborn Infant, Neonatal Asphyxia, Neonatal Bradycardia
- Trial name
- INSPIRE-D (NCT02347241)
- Testing
- Educational intervention
- Where
- Norway
- Volunteers
- 435 people
- Sponsor
- Oslo University Hospital
Cerebral Palsy, Reliability
Turkish Validity And Reliability Of The Hammersmith Infant Neurological Evaluation (Hine)
The high risk of infants are defined as having a negative environmental and biological factor history, where these factors can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Reliability, Infant Development, Infant, Premature, Diseases
- Trial name
- Hine (NCT04259177)
- Testing
- Scale
- Where
- Turkey (Türkiye)
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Sanko University
Infant, Newborn, Asphyxia Neonatorum
Optimising Newborn Nutrition During Therapeutic Hypothermia.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition
- Trial name
- NCT03278847
- Testing
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,030 people
- Sponsor
- Imperial College London
Perinatal Hypoxia
Serum Erythropoietin Level in Perinatal Asphyxia
This study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (Erythropoietin).
- Trial name
- NCT05018364
- Testing
- Serum erythropoietin level
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Cairo University
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