Clinical trials: Birth Asphyxia
Asphyxia Neonatorum
Randomized Clinical Trial Assessing Laryngeal Mask Airway Versus Face-mask Ventilation in Neonatal Resuscitation
The purpose of this study is to compare the use of a laryngeal mask airway (LMA) vs. face-mask ventilation (FMV) during first-line neonatal resuscitation in Mulago Hospital, Kampala, Uganda.
- Trial name
- LMAvsFMV (NCT02042118)
- Testing
- Laryngeal Mask Airway, Face mask ventilation
- Where
- Uganda
- Volunteers
- 50 people
- Sponsor
- Centre For International Health
Apnea of Newborn, Hypoxia Neonatal
A UK Interventional Trial in Premature Infants With Apnea of Prematurity Using a Simple, Non-invasive Vibratory Device to Study the Effectiveness in Supporting Breathing and General Stability
Purpose of Study: Apnoea of Prematurity (AOP) is common, affecting the majority of infants born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which contributes to multiple pathologies…
- Conditions
- Apnea of Newborn, Hypoxia Neonatal, Bradycardia Neonatal
- Trial name
- WAVE (NCT04528030)
- Testing
- WAVE device
- Volunteers
- 17 people
- Sponsor
- Inspiration Healthcare
Neonatal Resuscitation
Back Rubs or Foot Flicks for Neonatal Stimulation at Birth in a Low-resource Setting
Physical stimulation is the most common intervention during neonatal stabilization/resuscitation at birth and is recommended by neonatal resuscitation guidelines in high as well low-income settings.
- Trial name
- NCT04056091
- Testing
- Back rub stimulation, Foot flicks stimulation
- Where
- Uganda
- Volunteers
- 186 people
- Sponsor
- University Hospital Padova
Encephalopathy, Erythropoietin
Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial)
One million babies die, and at least 2 million survive with lifelong disabilities following neonatal encephalopathy (NE) in low and middle-income countries (LMICs), every year.
- Conditions
- Encephalopathy, Erythropoietin, Newborn Asphyxia
- Trial name
- EMBRACE (NCT05395195)
- Testing
- Erythropoietin, Supportive neonatal intensive care
- Where
- 10 sites in Bangladesh, India and 1 more
- Volunteers
- 504 people
- Sponsor
- Imperial College London
Newborn Asphyxia, Hemodynamic Instability
Fetal Assessment of the Myocardium and Evaluation of the Neonate
FAME-n aims to improve perinatal care by introducing new approaches to fetal and neonatal heart assessment. Better identification of high-risk deliveries requiring intervention will reduce perinatal asphyxia-related illness and…
- Conditions
- Newborn Asphyxia, Hemodynamic Instability, Myocardium; Ischemic, Fetal Distress
- Trial name
- FAME-n (NCT06186973)
- Testing
- Monitoring with Neobeat heart rate meter, Maternal arterial blood gases, Amniotic fluid lactate
- Where
- Norway
- Volunteers
- 220 people
- Sponsor
- Oslo University Hospital
Asphyxia Neonatorum
First Breath: Neonatal Resuscitation in Developing Countries
In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared…
- Trial name
- NCT00136708
- Testing
- Neonatal Resuscitation
- Where
- 7 sites in Argentina, Guatemala and 4 more
- Volunteers
- 120,009 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Hypoxia, in Liveborn Infant, Neonatal Asphyxia
Infant Special Program for In Hospital Resuscitation Education in the Delivery Room
The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn survival and neurologic outcomes.
- Conditions
- Hypoxia, in Liveborn Infant, Neonatal Asphyxia, Neonatal Bradycardia
- Trial name
- INSPIRE-D (NCT02347241)
- Testing
- Educational intervention
- Where
- Norway
- Volunteers
- 435 people
- Sponsor
- Oslo University Hospital
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
Asphyxia Neonatorum
Neonatal Resuscitation With Supraglottic Airway Trial
Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings.
- Trial name
- NeoSupra (NCT03133572)
- Testing
- Supraglottic airway, Face-mask
- Where
- Uganda
- Volunteers
- 1,163 people
- Sponsor
- Centre For International Health
Birth Asphyxia
Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents.
- Trial name
- NCT03798093
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- United States
- Volunteers
- 227 people
- Sponsor
- Sharp HealthCare
Asphyxia Neonatorum
Amikacin Pharmacokinetics to Optimize Dosing Recommendations in Neonates With Perinatal Asphyxia Treated With Hypothermia
As a part of a project on perinatal clinical pharmacology, the primary aim of the present project is to study amikacin pharmacokinetics (PK) and physiology in asphyxiated neonates treated with therapeutic hypothermia and to…
- Trial name
- Amicool (NCT04867993)
- Testing
- Amikacin
- Where
- Bosnia and Herzegovina
- Volunteers
- 80 people
- Sponsor
- University of Sarajevo
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
Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability.
- Conditions
- Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
- Trial name
- NEATO (NCT01913340)
- Testing
- Erythropoietin, Normal saline
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
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
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE.
- Trial name
- NCT07897032
- Testing
- Levetiracetam, Therapeutic hypothermia (whole body cooling)
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Alexandria University
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
Birth Asphyxia
Finding Solutions to Thrive After Birth Asphyxia in Africa
Neonatal encephalopathy (NE) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide.
- Trial name
- SANE-Uganda (NCT05275725)
- Testing
- Sildenafil
- Where
- Uganda
- Volunteers
- 18 people
- Sponsor
- Pia Wintermark
Asphyxia Neonatorum, Birth Asphyxia
Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application
Some newborn babies have difficulty breathing at birth and need help. When babies need help with breathing the clinical team, the team measures heart rate using a stethoscope to check its heart rate and figure out what kind of…
- Trial name
- NCT03913533
- Testing
- Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method, Heart rate assessment using Tap-based smartphone application
- Where
- Canada
- Sponsor
- University of Alberta
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
Neonatal Asphyxia
Asphyxia at Birth : Causes and Neonatal Outcome
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing…
- Trial name
- ABC-NEO (NCT03227536)
- Where
- France
- Volunteers
- 61,448 people
- Sponsor
- Hospices Civils de Lyon