Clinical trials: Infant Asphyxia
Asphyxia Neonatorum, Morbidity;Newborn
Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment
The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.
- Trial name
- VISNAT (NCT04145713)
- Testing
- Probiotic mixture
- Where
- Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Policlinico Hospital
Birth Asphyxia, Neonatal Resuscitation
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa
- Conditions
- Birth Asphyxia, Neonatal Resuscitation, Maternal Distress
- Trial name
- BabySaver (NCT03885492)
- Where
- Uganda
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Sanyu Africa Research Institute
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
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
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
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
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
Hypoxia Neonatal, Premature
Pulse Oximetry Measurement and Transfusions
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life.
- Conditions
- Hypoxia Neonatal, Premature, Blood Transfusion
- Trial name
- POMAT (NCT04249193)
- Testing
- Transfusion
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Christiana Care Health Services
Cerebral Palsy, Infant, Newborn, Disease
Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant, Newborn, Disease, Infant, Small for Gestational Age, Infant Asphyxia
- Trial name
- NCT04035291
- Testing
- exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Sanko University
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
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
Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability.
- Conditions
- Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
- Trial name
- NEATO (NCT01913340)
- Testing
- Erythropoietin, Normal saline
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Birth Asphyxia
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.
- Trial name
- CEBA (NCT01743742)
- Testing
- Vitamin E, Vitamin C
- Where
- India
- Volunteers
- 95 people
- Sponsor
- Sir Takhtasinhji General Hospital
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
Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia
Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy
Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen.
- Trial name
- NCT00624871
- Testing
- Ascorbic acid (vitamin C), Ibuprofen
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Al-Azhar University
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, 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
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
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.