Clinical trials: Asphyxia Neonatorum
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
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
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
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking…
- Trial name
- CORDMILK-FU (NCT03682042)
- Testing
- Umbilical Cord Milking
- Where
- 9 sites in India
- Volunteers
- 3,442 people
- Sponsor
- Nemours Children's Clinic
Asphyxia Neonatorum
Resident Training Enhanced by New Innovations: Teleintubation
The overall goal of this study was to create a simulation environment with repeated practice for residents and intense, immediate feedback.
- Trial name
- NCT02572427
- Testing
- Education for intubation skills, No added education for intubation skills
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University of Arkansas
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
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.
Stillbirth, Neonatal Death
Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda
A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital…
- Trial name
- NCT02273037
- Testing
- Fetal heart rate Doppler, Partograph
- Where
- 2 sites in Canada, Uganda
- Volunteers
- 1,987 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
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
Preterm Birth, Low Birth Weight
Perinatal Conditions Influencing Morbidity, Mortality, and Medical Care in Newborns
This study focuses on understanding the conditions that affect newborn health and survival from pregnancy to the first weeks of life at the Isidro Ayora Hospital.
- Conditions
- Preterm Birth, Low Birth Weight, Intrauterine Growth Restriction (IUGR), Perinatal Asphyxia
- Trial name
- UCE (NCT06653374)
- Testing
- Infant, Premature
- Where
- Ecuador
- Volunteers
- 26,000 people
- Sponsor
- HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
Intrapartum Fetal Distress, Neonatal Asphyxia
Oral Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
The goal of this feasibility pilot clinical trial is to determine if sildenafil citrate 50mg orally, up to three times during labor, can: 1) reduce perinatal mortality and/or bag and mask ventilation at birth in planned vaginal…
- Conditions
- Intrapartum Fetal Distress, Neonatal Asphyxia, Intrapartum Asphyxia, Instrumental Delivery; Affecting Fetus
- Trial name
- NCT06522854
- Testing
- Sildenafil 50 mg Oral Tablet
- Where
- 4 sites in Nigeria
- Sponsor
- University of Alabama at Birmingham
Birth Asphyxia, Premature Birth
Oxygen Toxicity in the Resuscitation in Extremely Premature Infants
The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.
- Trial name
- OXTOX (NCT00494702)
- Testing
- Resuscitation
- Where
- Spain
- Volunteers
- 88 people
- Sponsor
- Fundacion Para La Investigacion Hospital La Fe
Asphyxia Neonatorum, Birth Asphyxia
Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
Augmented Infant Resuscitator (AIR) is an inexpensive add-on, compatible with nearly every existing bag-valve mask and many types of ventilation equipment.
- Conditions
- Asphyxia Neonatorum, Birth Asphyxia, Perinatal Asphyxia
- Trial name
- NCT05349175
- Testing
- Augmented Infant Resuscitator (AIR)
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain.
- Trial name
- NCT00383305
- Testing
- Cool-Cap
- Where
- 27 sites in United States, Canada and 2 more
- Volunteers
- 235 people
- Sponsor
- Olympic Medical
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.
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
Neonatal Disorder, Asphyxia Neonatorum
Early or Late Cord Clamping in the Depressed Neonate
This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation.
- Trial name
- NepCordIII (NCT02727517)
- Testing
- Early (≤ 60 seconds) cord clamping, Delayed (≥ 180 seconds) cord clamping
- Where
- Nepal
- Volunteers
- 90 people
- Sponsor
- Uppsala University
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