Clinical trials: Perinatal Asphyxia
Perinatal Mortality
Global Network Implementation of Helping Babies Breathe (HBB)
The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth attendants at health facilities in the Helping…
- Trial name
- NCT01681017
- Testing
- HBB/ENC Training and Equipment, HBB/ENC supplies
- Where
- 3 sites in India, Kenya
- Volunteers
- 70,704 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
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
Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn
Feasibility and Safety of Intranasally Administered Breast Milk in HIE
This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- F-NEO-BRIGHT (NCT06747260)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
Perinatal Asphyxia
A Study of 2-Iminobiotin in Neonates With Perinatal Asphyxia
In case of insufficient oxygen supply to the brain of a newborn child (perinatal asphyxia), toxic compounds will be formed. These toxic compounds will damage the cells of the brain.
- Trial name
- NCT01626924
- Testing
- 2-Iminobiotin
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 6 people
- Sponsor
- Neurophyxia B.V.
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
Perinatal Depression, Prognosis
Cohort Study on the Outcome and Influencing Factors of Perinatal Depression
1. Research and follow-up of the course and outcome of high-risk pregnant women with perinatal depression in the third trimester; 2. Factors affecting the outcome of the disease; 3. Recurrence of PND in pregnancy again; 4.
- Trial name
- NCT04517981
- Testing
- Psychological intervention, Comprehensive intervention
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai Mental Health Center, Jingan District
Hypoxic Ischemic Encephalopathy
Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of serum(s) neutrophil gelatinase-associated…
- Trial name
- NCT02683915
- Testing
- Therapeutic hypothermia
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Mansoura University Children Hospital
Perinatal Depression
Perinatal Mental Health for Refugee Women
Since February 24th, 2022, the beginning of Russia's aggression against Ukraine, more than 80,000 women were expected to give birth.
- Trial name
- PMH-RW (NCT05654987)
- Where
- 2 sites in Poland, Ukraine
- Volunteers
- 600 people
- Sponsor
- Universidad Nacional de Educación a Distancia
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
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
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
Hypoxic Ischaemic Encephalopathy
Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
This is a randomised controlled trial in newborn infants with perinatal asphyxial encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve cerebral metabolism and structure.
- Trial name
- TOBYXe (NCT00934700)
- Testing
- Xenon gas
- Where
- United Kingdom
- Volunteers
- 92 people
- Sponsor
- Imperial College London
Perinatal Asphyxia, Encephalopathy
Outcome After 24 Months of Participants in the TOBY Xenon Study
The objective of this study is to document the outcome at 2-3 years of age of participants of the TOBY Xe trial, to provide preliminary information about the later clinical effects of treatment with Xenon gas combined with…
- Trial name
- NCT03968861
- Testing
- Xenon
- Where
- 3 sites in United Kingdom
- Volunteers
- 69 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Perinatal Depression, Postpartum Depression
A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
Depressed mothers (pregnant and post-delivery) make up a significant portion of Maternal, Infant, and Early Childhood Home Visiting (MIECHV) clients.
- Conditions
- Perinatal Depression, Postpartum Depression, Family Conflict
- Trial name
- NCT04741776
- Testing
- Resilience Enhancement Skills Training, Problem-Solving Individual Therapy
- Where
- United States
- Volunteers
- 166 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Fetal Heart Rate Abnormalities, Respiratory Depression
Safer Births - Reducing Perinatal Mortality
Safer Births is a research and development collaboration to establish new knowledge and new innovative products to better equip and increase competence of health workers for safer births and increased newborn survival worldwide.
- Conditions
- Fetal Heart Rate Abnormalities, Respiratory Depression, Birth Asphyxia, Neonatal Resuscitation
- Trial name
- NCT01869582
- Testing
- Fetoscope, Fetal heart rate, Upright Resuscitator, Resuscitation, Doppler, Fetal heart rate
- Where
- 2 sites in Tanzania
- Volunteers
- 20,000 people
- Sponsor
- Helse Stavanger HF
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
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
Perinatal Mental Health
The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU.
- Trial name
- NCT06467916
- Testing
- Behavioral Treatment
- Where
- 2 sites in United States
- Volunteers
- 72 people
- Sponsor
- University of Colorado, Denver
Perinatal Depression
Early Detection of Perinatal Depression With Wearable Technology
The goal of this feasibility study is to learn whether wearable devices and self-report surveys can help researchers better understand changes in mood during pregnancy and after birth in young pregnant individuals with a history…
- Trial name
- BLUESMAPPED (NCT07784244)
- Testing
- Oura Ring (Photoplethysmography-based wearable ring), EmbracePlus Watch (Electrodermal activity wristband sensor)
- Where
- Canada
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Women's College Hospital