Clinical trials: Asphyxia Neonatorum
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
Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia
As a part of a project on perinatal clinical pharmacology, the primary aim of the present project is to study amikacin pharmacokinetics (PK) and physiology in asphyxiated neonates treated with therapeutic hypothermia and to…
- Trial name
- Amicool (NCT04867993)
- Testing
- Amikacin
- Where
- Bosnia and Herzegovina
- Volunteers
- 80 people
- Sponsor
- University of Sarajevo
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
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
Birth Asphyxia
Asphyxia Associated Metabolite Biomarker Investigation 2
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia.
- Trial name
- AAMBI2 (NCT04714502)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 144 people
- Sponsor
- InfanDx AG
Hypoxic-Ischemic Encephalopathy, Hypoxia Neonatal
Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia
The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Hypoxia Neonatal, Cerebral Ischemia of Newborn, Anemia, Neonatal
- Trial name
- NCT03352310
- Testing
- autologous umbilical cord blood (UCB), standard care
- Where
- Hong Kong
- Volunteers
- 40 people
- Sponsor
- Mononuclear Therapeutics Ltd.
Hypoxic Ischemic Encephalopathy
Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)
In this prospective trial the investigators plan to study the efficacy of erythropoietin as a therapeutic agent in neonates who suffer from brain injury following perinatal asphyxia.
- Trial name
- NCT00945789
- Testing
- Human recombinant erythropoietin, EEG and Brain MRI, Nitric oxide measurement in the blood
- Where
- Egypt
- Volunteers
- 45 people
- Sponsor
- Tanta University
Birth Asphyxia
Neuroprotective Efficacy of Postnatal Magnesium Sulphate in Term Infants With Birth Asphyxia
Birth/Perinatal asphyxia in Pakistan continues to be a leading cause of neonatal mortality and morbidity. It is estimated that around 80 to 120,000 neonates either suffer from or die from birth/perinatal asphyxia every year.
- Trial name
- NCT05707962
- Testing
- Magnesium sulfate
- Where
- Pakistan
- Volunteers
- 178 people
- Sponsor
- University of Health Sciences Lahore
Hypoxic-ischemic Encephalopathy
Neonatal Erythropoietin in Asphyxiated Term Newborns
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
- Trial name
- NEAT (NCT00719407)
- Testing
- erythropoietin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of California, San Francisco
Neonatal Asphyxia
Asphyxia at Birth : Causes and Neonatal Outcome
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing…
- Trial name
- ABC-NEO (NCT03227536)
- Where
- France
- Volunteers
- 61,448 people
- Sponsor
- Hospices Civils de Lyon
Death, Neurodevelopmental Impairment
Apgar-Score in Asphyxiated Infants Under Resuscitation
The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and mortality of asphyxiated newborns.
- Trial name
- NCT01193751
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Technische Universität Dresden
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 22 sites in United States
- Volunteers
- 173 people
- Sponsor
- ReAlta Life Sciences, Inc.
Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain.
- Trial name
- NCT00383305
- Testing
- Cool-Cap
- Where
- 27 sites in United States, Canada and 2 more
- Volunteers
- 235 people
- Sponsor
- Olympic Medical
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
Apnea of Newborn, Hypoxia Neonatal
A UK Interventional Trial in Premature Infants With Apnea of Prematurity Using a Simple, Non-invasive Vibratory Device to Study the Effectiveness in Supporting Breathing and General Stability
Purpose of Study: Apnoea of Prematurity (AOP) is common, affecting the majority of infants born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which contributes to multiple pathologies…
- Conditions
- Apnea of Newborn, Hypoxia Neonatal, Bradycardia Neonatal
- Trial name
- WAVE (NCT04528030)
- Testing
- WAVE device
- Volunteers
- 17 people
- Sponsor
- Inspiration 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
Birth Asphyxia
Umbilical Cord Milking in Non-Vigorous Infants
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for…
- Trial name
- MINVI (NCT03631940)
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1,730 people
- Sponsor
- Sharp HealthCare
Hypoxic Encephalopathy, Birth Asphyxia
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
- Conditions
- Hypoxic Encephalopathy, Birth Asphyxia, Neonatal Encephalopathy, Hypothermia, Newborn
- Trial name
- NCT05652738
- Testing
- Passive cooling application, cooling using Blanket roll III
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Alexandria University