Clinical trials: Neonatal Resuscitation, active
Newborn Morbidity
Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly
The aim of this study is to demonstrate, with a good level of evidence, the efficacy, safety and feasibility of placing an umbilical route through Wharton's jelly, in the context of emergency situations in the delivery room.
- Trial name
- CaDOm (NCT06915467)
- Testing
- Umbilical vein catheterization through Wharton's jelly procedure
- Where
- 5 sites in France
- Volunteers
- 26 people
- Sponsor
- Hôpital NOVO
Rare Diseases, Congenital Diaphragmatic Hernia
Intact Cord Resuscitation in CDH
Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20…
- Trial name
- CHIC (NCT04429750)
- Testing
- Immediate umbilical cord clamping, intact cord resuscitation
- Where
- 3 sites in France
- Volunteers
- 180 people
- Sponsor
- University Hospital, Lille
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
Fetal Distress, Fetal Hypoxia
Maternal Oxygen Supplementation for Intrauterine Resuscitation
More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia…
- Conditions
- Fetal Distress, Fetal Hypoxia, Labor and Delivery Complication
- Trial name
- MOXY (NCT05681624)
- Testing
- Maternal oxygen supplementation, Room air
- Where
- United States
- Volunteers
- 2,252 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Death; Neonatal, Morbidity;Newborn
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.
- Trial name
- NCT06087224
- Testing
- Teleneonatology
- Where
- 36 sites in United States, Canada
- Volunteers
- 947 people
- Sponsor
- Mayo Clinic
Hypofibrinogenemia, Hemorrhage
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex…
- Conditions
- Hypofibrinogenemia, Hemorrhage, Trauma Associated Hemorrhage, Hemorrhagic Shock
- Trial name
- CRYO-FIRST (NCT07218185)
- Testing
- Pathogen Reduced Cryoprecipitated Fibrinogen Complex
- Where
- 4 sites in United States
- Volunteers
- 320 people
- Sponsor
- Cerus Corporation
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
Osbtetric Brachial Plexus Palsy
Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation
Neonatal brachial plexus palsy is a pathology that remains common and one of its sequelae is lack of external rotation of the shoulder.
- Trial name
- CinéLDSS (NCT06845228)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cardiac Arrest
Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
Newborn infants who require cardiopulmonary resuscitation at birth receive chest compression using a 3-Compression to 1-Ventilation (3:1 C:V) ratio.
- Trial name
- SUR1VE-2 (NCT06577818)
- Testing
- CC+SI (Chest compression during sustained inflation), 3:1 C:V (3:1 Compression:Ventilation ratio)
- Where
- Canada
- Volunteers
- 554 people
- Sponsor
- University of Alberta
Spinal Cord Injury Cervical, Tetraplegia
Epidural Stimulation for Upper Extremity Function
Restoring upper extremity function in patients with cervical spinal cord injury is extremely important for patients' independence and quality of life.
- Trial name
- NCT06437548
- Testing
- Percutaneous spinal cord stimulation
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Respiratory Failure, Premature Neonates
Supraglottic Airway for Resuscitation in Preemies
The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature…
- Conditions
- Respiratory Failure, Premature Neonates, Delivery Room Resuscitation, Positive Pressure Ventilation
- Trial name
- SUPREEMIE (NCT07419438)
- Testing
- Supraglottic Airway
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Pennsylvania
Choking in Infants, Cardiopulmonary Resuscitation (CPR)
Parental Knowledge of First Aid for Choking and Cardiopulmonary Resuscitation in Infants Under One Year of Age
This study aims to assess the knowledge of parents regarding first aid for choking and cardiopulmonary resuscitation (CPR) in infants under one year of age.
- Conditions
- Choking in Infants, Cardiopulmonary Resuscitation (CPR), First Aid Training, Parental Knowledg
- Trial name
- NCT06976463
- Where
- Poland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Andrzej Frycz Modrzewski Krakow University
Hypothermia, Immature Newborn
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO…
- Trial name
- NCT01604317
- Testing
- Resuscitation-torso plastic bag, Resuscitation-partial-head plastic bag
- Where
- Zambia
- Volunteers
- 182 people
- Sponsor
- University of Alabama at Birmingham
Asphyxia Neonatorum, Fetal Hypoxia
Sustained Cord Circulation at Emergency Cesarean Section
The goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency Cesarean section.
- Trial name
- SUCCECS (NCT06540222)
- Testing
- Sustained cord (≥ 180 seconds) resuscitation, Routine (< 60 seconds) cord clamping
- Where
- 12 sites in Sweden
- Volunteers
- 2,200 people
- Sponsor
- Region Skane
Asphyxia Neonatorum, Resuscitation
Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants
This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and…
- Trial name
- SAVE (NCT04070560)
- Testing
- Intact cord (≥ 180 seconds) resuscitation, Early (≤ 60 seconds) cord clamping
- Where
- 3 sites in Sweden
- Volunteers
- 600 people
- Sponsor
- Lund University
Newborn Resuscitation, Severe Malnutrition
Enhancing Pediatric Acute Care Through Adaptive E-Learning and In-Person Skills Practice in Tanzania
The goal of this clinical trial is to evaluate whether the integration of in-person skills practice (ISP) with an adaptive e-learning platform can improve refresher learning progress (RLP) among healthcare providers in pediatric…
- Conditions
- Newborn Resuscitation, Severe Malnutrition, Severe Malaria, Severe Pneumonia
- Trial name
- PACE (NCT06635733)
- Testing
- Rhapsode Capable™ Platform (Intervention Group), Paper-based ISP (Control Group)
- Where
- Tanzania
- Volunteers
- 100 people
- Sponsor
- Stanford University
Cardiac Arrest, Congenital Heart Disease
Resuscitation Registry in CHD
Children with congenital heart defects are far more likely to suffer a cardiovascular arrest and be in the need of cardiopulmonary resuscitation than healthy children or those with diseases of other organ systems, especially…
- Trial name
- PRO-CHD (NCT05373498)
- Where
- 3 sites in Germany
- Volunteers
- 400 people
- Sponsor
- Leipzig Heart Science gGmbH
Neonatal Resuscitation, Apnea Neonatal
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method.
- Trial name
- MVP (NCT06849596)
- Testing
- Ventilator derived positive pressure ventilation - V-PPV, T-piece resuscitator (TPR)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 780 people
- Sponsor
- Michelle Baczynski
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
Cardiac Arrest Neonatal
Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation
When a baby is born with a low heart rate or no heart rate, the clinical team must provide breathing support and chest compressions (what is call cardiopulmonary resuscitation or CPR).
- Trial name
- NCT05738148
- Testing
- Vasopressin, Epinephrine
- Where
- Canada
- Volunteers
- 8 people
- Sponsor
- University of Alberta