Clinical trials: Birth Asphyxia
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
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 Encephalopathy
Sildenafil Administration to Treat Neonatal Encephalopathy
Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious condition causing significant mortality and long-term morbidity, including cerebral palsy and mental retardation.
- Trial name
- SANE-01 (NCT02812433)
- Testing
- Sildenafil, Ora-Blend
- Where
- Canada
- Volunteers
- 28 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Neonatal Encephalopathy
CoolCap Followup Study-Coordination of Participating Centers
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial.
- Trial name
- NCT00581581
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Rochester
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
Neonatal Death, Birth Asphyxia
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
Helping Babies Breathe (HBB) is a program that teaches providers in low- and middle-income countries about neonatal resuscitation. Historically, HBB training was delivered in person.
- Trial name
- NCT05854745
- Testing
- HBB Virtual Training, HBB In-person Training
- Where
- Ethiopia
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Stanford University
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates (BANON)
Validation 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 and a preliminary human study.
- Trial name
- NCT03357250
- Where
- 11 sites in Germany
- Volunteers
- 553 people, healthy volunteers welcome
- Sponsor
- Life Science Inkubator
Postpartum Hemorrhage, Neonatal Asphyxia
Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and…
- Trial name
- NCT03254628
- Testing
- Helping Mothers Survive - Bleeding After Birth training, Helping Babies Breathe, Mentor
- Volunteers
- 3,440 people
- Sponsor
- Jhpiego
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
Prolonged First Stage of Labor, Failure of Cervical Dilation as Antepartum Condition
Drotaverine to Shorten the Length of Labor
Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being, and for the providers of the birth services.
- Conditions
- Prolonged First Stage of Labor, Failure of Cervical Dilation as Antepartum Condition, Labor Pain, Mild Birth Asphyxia, APGAR 4-7
- Trial name
- NCT01639027
- Testing
- Drotaverine
- Where
- Egypt
- Volunteers
- 352 people
- Sponsor
- Ain Shams Maternity Hospital
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping…
- Trial name
- CORDMILK (NCT03657394)
- Testing
- Umbilical cord milking
- Where
- 9 sites in India
- Volunteers
- 3,442 people
- Sponsor
- Nemours Children's Clinic
Cerebral Palsy, Infant, Premature, Diseases
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
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, Premature, Diseases, Infant Development, Neurologic Disorder
- Trial name
- highrisk (NCT05217186)
- Testing
- Measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Kahramanmaras Sutcu Imam University
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
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
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
Hypoxia Neonatal
Owlet Smart Sock 3 Accuracy on Infants
The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a…
- Trial name
- NCT05635513
- Testing
- Owlet OSS V3
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Owlet Baby Care, Inc.
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or…
- Trial name
- MIDAB-FU (NCT03681314)
- Testing
- Umbilical Cord Milking
- Where
- 3 sites in India
- Sponsor
- Nemours Children's Clinic
Neonatal Hypoxia
Citicoline as Neuroprotector in Neonates Exposed to Hypoxia
Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial
- Trial name
- NCT03949049
- Testing
- Citicoline
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Sherief Abd-Elsalam
Hypoxic-Ischemic Encephalopathy, Pain
The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the…
- Trial name
- Pain in HIE (NCT07526233)
- Testing
- scent
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Alev Sivasli
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