Clinical trials: Delivery Room Resuscitation
Preterm Birth, Respiratory Distress Syndrome
Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant
Lung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC).
- Conditions
- Preterm Birth, Respiratory Distress Syndrome, Lung Diseases
- Trial name
- NCT02493920
- Testing
- Sustained lung inflation, mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Neonatal Resuscitation, Delivery Room Resuscitation
Supraglottic Airway for Resuscitation Trial
This is a hybrid type 3 effectiveness-implementation parallel cluster randomized superiority trial designed to compare two strategies to promote early supraglottic airway (SA) rescue during neonatal resuscitation, with a focus on…
- Conditions
- Neonatal Resuscitation, Delivery Room Resuscitation, Positive Pressure Ventilation, Infant, Newborn
- Trial name
- SUGAR (NCT07150923)
- Testing
- Enhanced Standard of Care ("Enhanced"), Enhanced Standard of Care ("Enhanced-Plus")
- Where
- 30 sites in United States
- Volunteers
- 36,503 people
- Sponsor
- Children's Hospital of Philadelphia
Vital Signs
The Effect of Postnatal Lying Position on Cerebral Oxygenation in Newborns
In the international delivery room guidelines, it is not specified which position is optimal for the baby stabilization. Here, the investigators want to evaluate the effects of the positions on postnatal adaptation and cerebral…
- Trial name
- NCT05868980
- Testing
- vital signs by postpartum position
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Dr. Behcet Uz Children's Hospital
Placental Transfusion
Delivery Room Assistance With the Placental Circulation Intact
Preterm newborns receiving placental transfusion at birth (a volume of blood coming from the placenta towards the newborn till the cord is left unclamped) have better neonatal outcomes (in particular reduction of intraventricular…
- Trial name
- PCI-T (NCT02671305)
- Testing
- placental circulation intact, cord milking
- Where
- 8 sites in Italy
- Volunteers
- 212 people
- Sponsor
- University of Florence
Respiratory Distress Syndrome
Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome
BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical…
- Trial name
- SLIS (NCT01440868)
- Testing
- Sustained lung inflation
- Where
- Italy
- Volunteers
- 276 people
- Sponsor
- University of Florence
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
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
Premature Infant, Respiratory Distress Syndrome
The Hilo Pilot -Trial to Assess Feasibility
Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8% of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before 29…
- Trial name
- HiLo-Pilot (NCT03706586)
- Testing
- 30% group, 60% group
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- University of Alberta
Hypoxia
Comparison of Two Pulse Oximeters in Delivery Room
Time to stable reading of oxygen saturation at the delivery room will be compared between two different devices.
- Trial name
- NCT02704585
- Testing
- Nellcor, Masimo
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Shaare Zedek Medical Center
Oxidative Stress
Saturation Targets and Resuscitation in Preterm Trial
The purpose of this research project is to determine if use of optimized target oxygen strategy during delivery room resuscitation can reduce oxidative stress in premature newborns.
- Trial name
- STARTPreterm (NCT03115463)
- Testing
- Titration of oxygen during neonatal resuscitation
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- University of Texas Southwestern Medical Center
Resuscitation
Effect of Establishing Functional Residual Capacity During Newborn Resuscitation on Oxygenation
Currently, newborns receive 100% supplemental oxygen by free flow when they remain cyanotic despite demonstrating regular respiratory effort.
- Trial name
- NCT00531102
- Testing
- continuous positive airway pressure, Free flow oxygen
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Calgary
Prematurity, Oxidant Injury
Use of Blended Oxygen for Delivery Room Resuscitation of Very Low Birth Weight Infants
We propose a preliminary trial to evaluate the safety and efficacy of using more restricted oxygen during resuscitation for VLBW infants than is utilized currently in an effort to reduce the oxidant stress of such treatment, and…
- Trial name
- NCT00369720
- Testing
- Titration of oxygen in delivery room
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Neil Finer
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
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
Transient Tachypnea
Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial
Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU).
- Trial name
- NCT01082900
- Testing
- Prophylactic CPAP Administration
- Where
- United States
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- New York Hospital Queens
Resuscitation, Infant, Newborn
Delivery Room Intervention and Evaluation Network
The American Academy of Pediatrics (AAP) convened the multi-center Delivery Room Intervention and Evaluation (DRIVE) Network to establish essential infrastructure to collect, coordinate, and analyze core demographic…
- Trial name
- DRIVE Network (NCT06803498)
- Testing
- Receipt of significant resuscitation intervention at birth
- Where
- United States
- Volunteers
- 3,000,000 people
- Sponsor
- American Academy of Pediatrics
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
Apnea, Bradycardia
MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room
Establishing breathing after birth is vital for survival and long-term health of premature babies. 10% of all preterm babies fail to breathe after birth and require help with breathing.
- Trial name
- MRSOPA (NCT02375230)
- Testing
- Control group, MR SOPA
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- University of Alberta
Premature Birth
HeartLight Pulse Study: Evaluation of Heart Rate Using an Electronic Stethoscope and Pre Placed ECG in the Delivery Room
This study will evaluate the accuracy of both an electronic stethoscope and electrocardiogram (ECG) to evaluate heart rate in neonatal patients in the delivery suite.
- Trial name
- HLPulseS (NCT02747069)
- Testing
- NICU electronic stethoscope, Newborns <32 weeks and ECG
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- University of Nottingham