Clinical trials: Asphyxia
Hypoxic Ischemic Encephalopathy
Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia
The purpose of this study is to determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of treatment with hypothermia.
- Trial name
- NeoNATI (NCT01241019)
- Testing
- Topiramate in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia
- Where
- 2 sites in Italy
- Volunteers
- 64 people
- Sponsor
- Meyer Children's Hospital IRCCS
Shoulder Dystocia,, Brachial Plexus Injury
New Prophylactic Maneuver: the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia
Shoulder dystocia is a major obstetric emergency defined as a delivery requiring maneuver in addition to downward traction on the fetal head for delivery of the shoulders.
- Conditions
- Shoulder Dystocia,, Brachial Plexus Injury, Asphyxia,, Hematoma,
- Trial name
- CONTRADYS (NCT01297439)
- Testing
- suctioning of fetal nose and mouth during delivery, Pushing maneuver
- Where
- France
- Volunteers
- 1,538 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Mortality
Lufwanyama Neonatal Survival Project
We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify…
- Trial name
- LUNESP (NCT00518856)
- Testing
- Neonatal resuscitation protocol, Standard of care
- Volunteers
- 3,559 people, healthy volunteers welcome
- Sponsor
- Boston 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
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
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
Neonatal Encephalopathy
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly.
- Trial name
- NCT06098833
- Testing
- Sildenafil, Ora-Blend
- Where
- 3 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Pia Wintermark
Hypoxic Ischaemic Encephalopathy
Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy
The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in Switzerland who were admitted to the neonatal and intensive care units offering…
- Trial name
- NCT02800018
- Testing
- risk factors
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Children's Hospital, Zurich
Natural Childbirth, Water Birth
Effectiveness and Safety in Maternal and Neonatal Outcomes in Water Birth.
Childbirth is a unique and non-transferable experience in the life of a woman, her partner and her family. It is a very intense process that requires accompaniment and, in the vast majority of cases, requires analgesic support in…
- Conditions
- Natural Childbirth, Water Birth, Neonatal Asphyxia, Outcome, Adverse Birth
- Trial name
- NCT06429111
- Testing
- Epidural analgesia, Immersion water
- Where
- Spain
- Volunteers
- 642 people
- Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Neonatal Acidemia and Hypoxia
Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment
This study aims to improve understanding of how fetuses respond to oxygen deprivation during labor by re-evaluating cardiotocography (CTG) recordings using a physiology-based interpretation approach and comparing these findings…
- Trial name
- NOAH (NCT07629271)
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Neonatal Asphyxia, Intrapartum Fetal Distress
Intrapartum Sildenafil in Laboring Mothers
The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to…
- Conditions
- Neonatal Asphyxia, Intrapartum Fetal Distress, Development, Infant, Intrapartum Asphyxia
- Trial name
- PRISM (NCT06377098)
- Testing
- Sildenafil 50 mg Oral Tablet
- Where
- 3 sites in Cameroon, Kenya and 1 more
- Sponsor
- University of Alabama at Birmingham
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
Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2
This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Perinatal Asphyxia, Hypocapnia
- Trial name
- HENRIC (NCT02700854)
- Testing
- 5% carbon-dioxide inhalation
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
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)
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to…
- Trial name
- NCT06090968
- Testing
- Umbilical cord milking, Immediate cord clamping
- Where
- India
- Volunteers
- 200 people
- Sponsor
- Lady Hardinge Medical College
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
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
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-Ischaemic Encephalopathy, Neonatal Encephalopathy
Intranasal Breast Milk Therapy in HIE
This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term…
- Conditions
- Hypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Perinatal Asphyxia, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- NEO-BRIGHT (NCT06746532)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 80 people
- Sponsor
- Semmelweis University
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