Clinical trials: Infant Asphyxia
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
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
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
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
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
Encephalopathy, Erythropoietin
Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year.
- Conditions
- Encephalopathy, Erythropoietin, Newborn Asphyxia
- Trial name
- EMBRACE (NCT05395195)
- Testing
- Erythropoietin, Supportive neonatal intensive care
- Where
- 10 sites in Bangladesh, India and 1 more
- Volunteers
- 504 people
- Sponsor
- Imperial College London
Asphyxia Neonatorum
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation
- Trial name
- NCT01866358
- Testing
- Intraosseous infusion, Umbilical vein infusion
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Third Military Medical University
Asphyxia, Resuscitation
Resuscitation Table Height for Face-mask Ventilation in Infants
Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while…
- Conditions
- Asphyxia, Resuscitation, Newborn Morbidity
- Trial name
- ForTab (NCT06254651)
- Testing
- High resuscitation table, Low resuscitation table
- Where
- Italy
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Birth Asphyxia
Enhancing Neonatal Sucking Reflex: A Study on the Efficacy of Magnesium Sulphate in Severe Birth Asphyxia
Children's Hospital Multan is a tertiary care teaching hospital in South Punjab, the poorest and most backward area of Punjab, Pakistan, where a significant number of newborns suffer from birth asphyxia.
- Trial name
- NCT06468475
- Testing
- Magnesium Sulphate infusion
- Where
- Pakistan
- Volunteers
- 80 people
- Sponsor
- RESnTEC, Institute of Research
Encephalopathy, Hypoxic-Ischemic, Infant, Newborn, Diseases
Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome
Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per…
- Trial name
- ALBINO (NCT03162653)
- Testing
- Allopurinol, Mannitol
- Where
- 12 sites in Austria, Belgium and 10 more
- Volunteers
- 760 people
- Sponsor
- University Hospital Tuebingen
Neonatal Asphyxia
Randomized Cluster Trial on Innovative and Standard Strategies for Neonatal Resuscitation Training (RCPNEOPERU Project)
Background: About 10% of all newborns may have difficulty breathing and require support by trained personnel. In Peru, 90% of deliveries occur in health facilities; however there is not a national neonatal resuscitation and…
- Trial name
- RCPNEOPERU (NCT03210194)
- Testing
- Standard Neonatal Resuscitation Training, MP-ICT Neonatal Resuscitation Training
- Where
- Peru
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Universidad Peruana Cayetano Heredia
Heart Arrest, Birth Asphyxia
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation? Overall objective: CC superimposed by…
- Conditions
- Heart Arrest, Birth Asphyxia, Bradycardia
- Trial name
- SURV1VE (NCT02858583)
- Testing
- CC+SI, 3:1 C:V
- Where
- 4 sites in Austria, Canada
- Volunteers
- 27 people
- Sponsor
- University of Alberta
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
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
Asphyxia Neonatorum, Resuscitation
Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants
This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and…
- Trial name
- SAVE (NCT04070560)
- Testing
- Intact cord (≥ 180 seconds) resuscitation, Early (≤ 60 seconds) cord clamping
- Where
- 3 sites in Sweden
- Volunteers
- 600 people
- Sponsor
- Lund University
Sepsis, Pneumonia
Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project
The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal…
- Conditions
- Sepsis, Pneumonia, Omphalitis, Birth Asphyxia
- Trial name
- EmONC (NCT01751945)
- Testing
- EmONC package
- Where
- Pakistan
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
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
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
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
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