Clinical trials: Newborn Resuscitation
Newborn Resuscitation, Heart Rate Monitoring
The NeoBeat Efficacy Study for Newborns
In a multicenter randomized controlled trial the investigators will evaluate the efficacy of the novel heart rate meter NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of…
- Trial name
- NCT03849781
- Testing
- NeoBeat with a visible display
- Where
- Norway
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Helse Stavanger HF
Computer Simulation, Neonatal Resuscitation
Computer Debriefing and Screen-based Simulation
Debriefing after simulation plays a crucial role in student learning and medical practice. This paper focuses on impact of computer debriefing technique on knowledge retention of midwives during screen-based simulation of…
- Trial name
- NCT03844009
- Testing
- Computer integrated debriefing
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Ilumens
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
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
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
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
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
Premature Birth
Prophylactic DR-CPAP on Late Preterm Infants Born by C-section: an RCT
A Pragmatic Randomized Controlled Pilot Trial to Evaluate the Impact of Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen in Spontaneously Breathing Late Preterm Newborn Infants Born by…
- Trial name
- PLANT (NCT05204719)
- Testing
- Prophylactic Delivery Room Continuous Positive Airway Pressure
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
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
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates (BANON)
Validation of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.
- Trial name
- NCT03357250
- Where
- 11 sites in Germany
- Volunteers
- 553 people, healthy volunteers welcome
- Sponsor
- Life Science Inkubator
Neonatal Resuscitation
Doppler Ultrasound Compared With Stethoscope to Assess Heart Rate (HR)
This is a prospective randomized controlled trial comparing heart rate measurement by Doppler ultrasound or auscultation with a stethoscope in newborn infants who require stabilization or resuscitation immediately after birth.
- Trial name
- NCT04242654
- Testing
- Handheld fetal doppler ultrasound
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Columbia University
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
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
Preterm Birth
Use of CO2 Detectors to Help Provide Effective Breaths During Resuscitation of Preterm Newborns
Effective ventilation is the single most vital intervention to improve outcome of resuscitation in the neonatal population. Assessments of effective ventilations are based on clinical parameters, but may be difficult due to…
- Trial name
- NCT04287907
- Testing
- Monitor Group
- Where
- Singapore
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- KK Women's and Children's Hospital
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
Respiratory Distress
Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation
The stomach of the newborn baby is often emptied soon after birth to prevent breathing problems (respiratory distress). Babies born with meconium-stained amniotic fluid and those with increased secretions associated with birth by…
- Trial name
- NCT00729989
- Testing
- Gastric suctioning
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Benjamin T. Stevens
Neonatal Resuscitation
SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL
This study is designed to compare two different methods of oropharyngeal suctioning (with bulb syringe or suction catheter) in newborn infants at birth.
- Trial name
- NEOSUC (NCT05472155)
- Testing
- Bulb syringe, Suction catheter
- Where
- Ethiopia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Birth Asphyxia, Neonatal Resuscitation
The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
To examine the usability, safety and acceptability of the BabySaver kit: a novel device for neonatal resuscitation in a low-income region in Africa
- Conditions
- Birth Asphyxia, Neonatal Resuscitation, Maternal Distress
- Trial name
- BabySaver (NCT03885492)
- Where
- Uganda
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Sanyu Africa Research Institute
Face Mask Ventilation in Neonatal Resuscitation
Applied Forces During Neonatal Ventilation With Different Face Masks
This trial compares the applied forces exerted on the face of a modified preterm neonatal manikin with three different face masks.
- Trial name
- NCT07161752
- Testing
- Anatomical face mask 1, Anatomical face mask 2, Round face mask
- Where
- Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
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