Clinical trials: Neonatal Resuscitation
Infant, Newborn
Risk Related Assistance During Stabilization In Newborns At Birth
Approximately 10% of term infants and up to 50% of preterm infants less than 32 weeks require stabilization and / or ventilatory support at the time of transition at birth.
- Trial name
- NCT05023694
- Testing
- Video recordings, Video recordings after corrective measures in adverse events
- Where
- Spain
- Volunteers
- 128 people
- Sponsor
- Manuel Sanchez Luna
Stillbirth, Neonatal Respiratory Depression
Newborn Heart Rate as a Catalyst for Improved Survival
Heart rate (HR) is not routinely assessed during newborn resuscitations in low- and lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh stillbirths have a heartbeat and are live born.
- Conditions
- Stillbirth, Neonatal Respiratory Depression, Neonatal Bradycardia, Neonatal Resuscitation
- Trial name
- NCT03799861
- Testing
- Epoch 2: HBB with NeoBeat, Epoch 3: HR-guided HBB
- Where
- 3 sites in Democratic Republic of the Congo
- Volunteers
- 24,034 people, healthy volunteers welcome
- Sponsor
- American Academy of Pediatrics
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Renal Failure
Renal Replacement Therapy in Neonates
The circumstances for setting up dialysis in the neonatal period are multiple: congenital anomaly of the kidney and urinary tract (CAKUT), secondary acute renal failure whose etiologies are multiple (sepsis, hypovolemia…
- Trial name
- Neo-Renal (NCT05456659)
- Where
- France
- Volunteers
- 72 people
- Sponsor
- University Hospital, Strasbourg, France
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
Extreme Prematurity - Less Than 28 Weeks
Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants
The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen…
- Trial name
- PRESOX (NCT01773746)
- Testing
- Neonatal Resuscitation
- Where
- 22 sites in United States, Austria and 10 more
- Volunteers
- 80 people
- Sponsor
- Sharp HealthCare
Newborn Resuscitation
PEEP Resuscitation Trial
Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help.
- Trial name
- PEEPrest (NCT02971553)
- Testing
- Upright Resuscitator with PEEP, Upright Resuscitator
- Where
- Tanzania
- Volunteers
- 330 people
- Sponsor
- Helse Stavanger HF
Hypothermia, Newborn
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
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
- NCT01604460
- Testing
- Resuscitation with torso plastic bag, Resuscitation-no plastic bag
- Where
- Zambia
- Volunteers
- 275 people
- Sponsor
- University of Alabama at Birmingham
Resuscitation
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation [PPV]) for resuscitation in the delivery room…
- Trial name
- NCT00443118
- Testing
- T-piece resuscitator Neopuff TM, Self Inflating Bag with PEEP, Self Inflating Bag without PEEP
- Where
- 11 sites in United States, Argentina and 3 more
- Volunteers
- 1,032 people
- Sponsor
- Edgardo Szyld
Prematurity
Effect of Monitoring Devices on Healthcare Provider Performance During Neonatal Resuscitation
Babies born very early (at less than 32 weeks) usually need help to breath right at birth, also called neonatal resuscitation. Healthcare providers (HCPs) are specially trained to provide this help.
- Trial name
- NCT04521725
- Testing
- Respiratory Function Monitor (RFM), Cerebral Near-Infrared Spectroscopy (NIRS)
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- University of Alberta
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
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
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
Meconium Aspiration Syndrome
Meconium Aspiration and Tracheal Suctioning-Feasibility Study
Feasibility study to randomize non-vigorous newborn infants born through meconium-stained amniotic fluid to endotracheal suctioning or immediate resuscitation.
- Trial name
- MATS (NCT02708563)
- Testing
- Immediate intubation, Immediate resuscitation
- Sponsor
- St. Louis University
Intubation Complication, Newborn Morbidity
Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room
The investigators wished to determine whether estimating endotracheal tube (ETT) insertion depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by…
- Conditions
- Intubation Complication, Newborn Morbidity, Cardiopulmonary Resuscitation
- Trial name
- Intubated-DR (NCT03770104)
- Testing
- ETT insertion depth using Spanish recommendations, ETT insertion depth using international recommendations
- Where
- Spain
- Volunteers
- 280 people
- Sponsor
- Tania Carbayo Jiménez
Gastroschisis
Direct Peritoneal Resuscitation in Gastroschisis
This is a prospective, double-arm study designed to evaluate the tolerability of direct peritoneal resuscitation (DPR) in neonates with gastroschisis.
- Trial name
- NCT03205553
- Testing
- SoC Staged Silo Closure, Peritoneal Dialysis Solution/Dextrose 1.5%
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Arkansas