Clinical trials: Asphyxia Neonatorum
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
Sudden Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
Newborn Asphyxia, Hypothermia Neonatal
Effectiveness of Simulation-based Training Delivered to Special Newborn Care Providers on Resuscitation Management and Kangaroo Mother Care: Simulation-based Training for Asyphxia in Babies Trial (STAR-Baby Trial)
Summary Background Neonatal mortality remains a major global public health challenge, with about 2.4 million newborn deaths occurring within the first month of life in 2020.
- Trial name
- STAR-Baby (NCT07574944)
- Testing
- Simulation-based training using Neonatalie
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Integrated Development Foundation Nepal
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 Complication, Neonatal Asphyxia
Face Mask vs Laryngeal Mask in Neonatal Resuscitation
The goal of this single-centre interventional study without medication neither device (for procedure) is to improve training of health care personnel (physicians, nurses, and midwives) on neonatal resuscitation through manikin…
- Trial name
- ManiMask2025 (NCT06952088)
- Testing
- Training on Neonatal Resuscitation
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Cardiopulmonary Resuscitation, Newborn Asphyxia
Comparison of Visual Instructions for Inserting a Laryngeal Mask in a Neonatal Mannequin.
This research project compares the effectiveness of two visual instructions for inserting laryngeal masks. Researchers will assess the procedure performed by undergraduate health students on neonatal mannequins.
- Trial name
- Neo-LMi (NCT06502327)
- Testing
- Instructions A, Instructions B
- Where
- Peru
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- National University of San Marcos, Peru
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
Post Partum Hemorrhage, Asphyxia; Fetal
Evaluation of Maternal & Newborn Health Simulation Lab Centers of Excellence in Nepal
Postpartum hemorrhage and birth asphyxia are the leading causes of maternal and neonatal mortalities worldwide. Prevention and adequate treatment are, therefore crucial.
- Conditions
- Post Partum Hemorrhage, Asphyxia; Fetal, Maternal-Fetal Relations
- Trial name
- SLAB (NCT06577922)
- Testing
- Establishment of a simulation lab and provision of simulation based trainings
- Where
- Nepal
- Volunteers
- 1,464 people, healthy volunteers welcome
- Sponsor
- One Heart Worldwide
Fetal Distress, Perinatal Asphyxia
Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings
The PRISM pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of…
- Conditions
- Fetal Distress, Perinatal Asphyxia, Birth Asphyxia, Stillbirth
- Trial name
- PRISM (NCT05946681)
- Where
- Zambia
- Volunteers
- 1,017 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Neonatal Encephalopathy, Asphyxia Neonatorum
Heart Beat Variability in Neonatal Encephalopathy
This study will find out if analysing heartbeat in babies with brain injury, based on standard clinical monitors, can inform treatment decisions and monitor stress levels in real time
- Conditions
- Neonatal Encephalopathy, Asphyxia Neonatorum, Hypoxic-Ischemic Encephalopathy
- Trial name
- HeartBeat (NCT03179553)
- Where
- 5 sites in United Kingdom
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Imperial College London
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
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
Asphyxia Neonatorum, Birth Asphyxia
Augmented Infant Resuscitator to Enhance Newborn Ventilation
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
- AIR (NCT04820504)
- Testing
- Augmented Infant Resuscitator (AIR), AIR device without feedback
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Asphyxia Neonatorum
Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Verification 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.
- Trial name
- AAMBI (NCT03354208)
- Testing
- blood sampling
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Life Science Inkubator
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
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
Neonatal Encephalopathy, Cell Damage
Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Neonatal encephalopathy (NE) occurs in 1.8 to 7.7 infants per 1000 births.
- Conditions
- Neonatal Encephalopathy, Cell Damage, Metabolic Acidosis, Inflammation
- Trial name
- AGAIN (NCT03897101)
- Where
- 2 sites in Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University Hospital of Ferrara
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
Neonatal Asphyxia
Randomized Cluster Trial on Innovative and Standard Strategies for Neonatal Resuscitation Training (RCPNEOPERU Project)
Background: About 10% of all newborns may have difficulty breathing and require support by trained personnel. In Peru, 90% of deliveries occur in health facilities; however there is not a national neonatal resuscitation and…
- Trial name
- RCPNEOPERU (NCT03210194)
- Testing
- Standard Neonatal Resuscitation Training, MP-ICT Neonatal Resuscitation Training
- Where
- Peru
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Universidad Peruana Cayetano Heredia
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