Clinical trials: Newborn Resuscitation
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
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
Respiratory Depression Neonatal
Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Purpose: To evaluate the effectiveness of newborn resuscitation feedback supported by a mobile health application called LIVEBORN; secondarily, to evaluate the relative effectiveness of real-time guidance vs debriefing.
- Trial name
- NCT05963516
- Testing
- LIVEBORN: A Mobile Health Application (app) for Newborn Resuscitation, NeoBeat: Heart Rate Meter for Newborn Resuscitation
- Where
- 4 sites in Democratic Republic of the Congo
- Volunteers
- 14,679 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Premature Infant, Extremely Low Birth Weight
Time to Accurate Heart Rate on Neonatal Outcomes
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g.
- Conditions
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- Trial name
- GE-EKG (NCT04587934)
- Testing
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sharp HealthCare
Teamwork During Neonatal Resuscitation
Improving Teamwork for Neonatal Resuscitation
The Neonatal Resuscitation Program (NRP) is the curriculum used to teach providers how to care for newborns in the delivery room. Breakdowns in teamwork and communication contribute to NRP quality problems.
- Trial name
- NCT00651794
- Testing
- Teamwork training, Standard NRP curriculum, Skills practice with low-fidelity mannequin
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Premature Birth
Neonatal Resuscitation - Sustained Inflations
This study compares a fifteen second sustained inflation (SI) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.
- Trial name
- NCT02967562
- Testing
- Inflation Breaths, Sustained Inflation
- Where
- United Kingdom
- Volunteers
- 63 people
- Sponsor
- King's College London
Delivery Room Resuscitation
Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation.
- Trial name
- NCT01381068
- Testing
- End tidal CO2 monitor
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Neil Finer
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
Heart Arrest, Birth Asphyxia
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation? Overall objective: CC superimposed by…
- Conditions
- Heart Arrest, Birth Asphyxia, Bradycardia
- Trial name
- SURV1VE (NCT02858583)
- Testing
- CC+SI, 3:1 C:V
- Where
- 4 sites in Austria, Canada
- Volunteers
- 27 people
- Sponsor
- University of Alberta
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
Fluid Loss, Symptom Complex, Triple
Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation
Administration of intravascular (IV) fluid is the most common emergency department (ED) procedure. IV fluids are integral to increasing effective blood volume and ensuring organ perfusion in patients with volume depletion and…
- Conditions
- Fluid Loss, Symptom Complex, Triple, Emergencies
- Trial name
- NCT03133767
- Testing
- Lactated Ringer Solution, Normal Saline 0.9% Infusion Solution Bag
- Where
- United States
- Volunteers
- 157 people
- Sponsor
- Nicholas M Mohr
Hypothermia
Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming…
- Trial name
- NCT00603837
- Testing
- NeoWrap, InfaTherm
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Respiration; Insufficient or Poor, Newborn
Mask Ventilation With Different Face Masks During Neonatal Resuscitation
Most premature babies have difficulty breathing at birth and need help (what we call resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask.
- Trial name
- NCT01685697
- Testing
- Mask ventilation with a Laerdal face mask, Mask ventilation with a F&P face mask
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- University of Alberta
Birth Asphyxia
Umbilical Cord Milking in Non-Vigorous Infants
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for…
- Trial name
- MINVI (NCT03631940)
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1,730 people
- Sponsor
- Sharp HealthCare
Premature Birth
Effect of Presenting Survival Information as Text or Pictograph During Periviable Birth Counseling
Women recruited from the internet will be put in a hypothetical situation of being in labor at 22 weeks of pregnancy, and presented with information on the likelihood of survival and chance of disability for babies born at this…
- Trial name
- NCT04859114
- Testing
- Format of outcome data presentation, Displayed chance of survival
- Where
- United States
- Volunteers
- 1,052 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Intrauterine Resuscitation
Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM).
- Trial name
- O2P2 (NCT03581214)
- Testing
- No oxygen, Oxygen
- Where
- United States
- Volunteers
- 910 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
Resuscitation, Neonatal Prematurity
Monitoring Neonatal Resuscitation Trial
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV)…
- Conditions
- Resuscitation, Neonatal Prematurity, Positive-Pressure Respiration
- Trial name
- MONITOR (NCT03256578)
- Testing
- New Life Box Respiratory Function Monitor
- Where
- United States
- Volunteers
- 288 people
- Sponsor
- University of Pennsylvania
Electronic Fetal Monitoring, Fetal Hypoxia
Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings
Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is common practice on Labor and Delivery units in the United States.
- Conditions
- Electronic Fetal Monitoring, Fetal Hypoxia, Fetal-Placental Circulation
- Trial name
- O2C2 (NCT02741284)
- Testing
- Room air, 10L Oxygen by nonrebreather mask
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Nursing Students Education on Neonatal Resuscitation
The Impact of Pedagogical Framework in Education of Neonatal Resuscitation
Virtually 10% of newborns suffer respiratory distress at birth thus need intervention from proficient health professionals. Pakistan is one of the top ten countries that carry two-thirds of the global burden of neonatal deaths.
- Trial name
- NCT04748341
- Testing
- Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain), Traditional Method
- Where
- Pakistan
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- University of Lahore