Clinical trials: Neonatal Asphyxia
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
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
Asphyxia Neonatorum
Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for analgesia and sedation to term newborn…
- Trial name
- SANNI 1 (NCT03177980)
- Testing
- Fentanyl, Fentanyl and clonidine
- Where
- 2 sites in Sweden
- Volunteers
- 49 people
- Sponsor
- Region Skane
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
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.
Apnea of Prematurity, Preterm Birth
Hemodynamic Responses to Cardio-respiratory Events in Preterm Infants
Intermittent episodes of hypoxemia and/or bradycardia, also defined as cardio-respiratory events (CRE) are very frequent in preterm infants and may result in transient hypoxia and hypoperfusion of target organs, with possible…
- Conditions
- Apnea of Prematurity, Preterm Birth, Patent Ductus Arteriosus, Hypoxia, Brain
- Trial name
- NCT04184245
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Apgar; 0-3 at 1 Minute, Metabolic Acidosis
Autologous Stem Cells in Newborns With Oxygen Deprivation
The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.
- Conditions
- Apgar; 0-3 at 1 Minute, Metabolic Acidosis, Hypoxia, Brain, Multiple Organ Failure
- Trial name
- NCT01506258
- Testing
- Application of Stem Cells, Observation
- Where
- Mexico
- Volunteers
- 20 people
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
Acute Kidney Injury
Acute Kidney Injury in Newborns With Perinatal Asphyxia
The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to…
- Trial name
- NCT03617055
- Testing
- serum cystatin c
- Volunteers
- 50 people
- Sponsor
- Assiut University
Neonatal Resuscitation, Airway Management
Success of Laryngeal Mask Airway (LMA) Insertion During Continuous Chest Compressions in Neonatal Resuscitation: A Randomized Crossover Simulation Study
The purpose of this study is to evaluate the time required for laryngeal mask airway (LMA) insertion, first-attempt success rates, and airway sealing quality (air leak) during neonatal resuscitation with and without interrupting…
- Conditions
- Neonatal Resuscitation, Airway Management, Asphyxia Neonatorum, Cardiopulmonary Resuscitation (CPR)
- Trial name
- NCT07681960
- Testing
- Size 1 ProSeal™ LMA
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Kahramanmaras Sutcu Imam University
Periventricular Leukomalacia, White Matter Disease
Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain.
- Conditions
- Periventricular Leukomalacia, White Matter Disease, Hypoxic-Ischemic Encephalopathy, Demyelinating Diseases
- Trial name
- NCT06985303
- Testing
- Investigational Combination Product
- Sponsor
- MGAM LLC
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 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
Preterm, Patent Ductus Arteriosus
NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot
Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term/premature infants and sick neonates.
- Conditions
- Preterm, Patent Ductus Arteriosus, Sepsis, Asphyxia
- Trial name
- CE-NeoDoppler (NCT06646250)
- Testing
- NeoDoppler - CE certified
- Where
- Norway
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- St. Olavs Hospital
Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia
Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia, Neonatal Encephalopathy
- Trial name
- NCT05514340
- Testing
- Normal Saline along with standard treatment, Sovateltide along with standard treatment
- Where
- 4 sites in India
- Volunteers
- 40 people
- Sponsor
- Pharmazz, Inc.
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
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
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
Antepartum Hemorrhage, Postpartum Hemorrhage
Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan
The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a dismal pictures and after the floods of 2010-2011 the health infrastructure of this district was badly affected.
- Conditions
- Antepartum Hemorrhage, Postpartum Hemorrhage, Anemia, Eclampsia
- Trial name
- SRC (NCT02797353)
- Testing
- Maternal Neonatal and Child Health Interventions
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Birth Asphyxia With Neurologic Involvement
Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping
3 clinical sites enrolling in the primary MINVI trial (NCT03631940) will collect Near Infrared Spectroscopy (NIRS) data in the first 10 minutes of life on a subset of 200 non-vigorous term and near-term infants enrolled in the…
- Trial name
- MINVINIRS (NCT03621956)
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- 3 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Sharp HealthCare
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