Phase 3 N=648 Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Primary: Death or Chronic Lung Disease — 76; 68; 62 participants
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Phase 3 N=1,032 Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
Resuscitation
Primary: Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. — 93.7; 88; 93 percentage of participants
N/A N=21 Delayed Cord Clamping for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Primary: Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping — 17 Participants
N/A N=63 Neonatal Resuscitation - Sustained Inflations
Premature Birth
Primary: Expiratory Tidal Volume — 153; 194 ml/kg/min
N/A N=410 Monitoring Neonatal Resuscitation Trial
Resuscitation · Neonatal Prematurity · Positive-Pressure Respiration
Primary: Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg — 30.2; 30.7 percentage of inflations — p=0.896
N/A N=42 Time to Accurate Heart Rate on Neonatal Outcomes
Premature Infant · Extremely Low Birth Weight · Extreme Prematurity
Primary: Time to Heart Rate Display in iRes Warmer With Resusview — 16; 50 seconds from time of birth
N/A N=114 Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings
Electronic Fetal Monitoring · Fetal Hypoxia · Fetal-Placental Circulation
Primary: Mean Umbilical Artery Lactate at Delivery — 3.5; 3.4 mmol/L — p=0.69
N/A N=27 SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Heart Arrest · Birth Asphyxia · Bradycardia
Primary: Return of Spontaneous Circulation — 90; 615 seconds
N/A N=9 Chest Compression and Sustained Inflation
Newborn Infants Having Asystole or Bradycardia at Birth
Primary: Time Needed to Achieve Return of Spontaneous Circulation — 31; 138 seconds — p=0.05
N/A N=28 Impact of 2 Resuscitation Sequences on Management of Simulated Pediatric Cardiac Arrest
Cardiopulmonary Arrest · Pediatric ALL · Resuscitation
Primary: Median Alveolar Ventilation — 276; 370 ml
N/A N=49 Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
Delivery Room Resuscitation
Primary: PCO2 Level Outside of Desired Range (40-60 mmHg) — 9; 8 participants
N/A N=98 Improving Teamwork for Neonatal Resuscitation
Teamwork During Neonatal Resuscitation
Primary: Teamwork Event Rate — 9; 10.3; 12.8 teamwork events per minute
N/A N=460 Sustained Aeration of Infant Lungs Trial
Preterm Birth · Extreme Prematurity
Primary: Combined Outcome of Death or Bronchopulmonary Dysplasia — 125; 137 Participants
N/A N=62 Mask Ventilation With Different Face Masks During Neonatal Resuscitation
Respiration; Insufficient or Poor, Newborn
Primary: Difference in Percentage of Leak — 35; 30 % (percentage of mass leak)
Phase 2 N=149 Aerosolized Surfactant in Neonatal RDS
Respiratory Distress Syndrome, Newborn
Primary: Number of Participants With Adverse Events as a Measure of Safety and Feasibility — 3; 8; 4; 12 Participants
Phase 4 N=61 Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation
Respiratory Distress Syndrome, Newborn
Primary: Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of…
N/A N=441 Bedside Improvement of Resuscitation Through mHealth Feedback (BIRTH Study)
Respiratory Depression Neonatal
Primary: Mean Duration of Suctioning Among All Live Births — 21.9; 15.7; 34.1; 23.2 seconds
N/A N=31 Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Respiratory Distress Syndrome in Premature Infants · Very Low Birth Weight Baby
Primary: Maximum Factional Inspired Oxygen Percent (FiO2) — 48; 39 percentage of Inspired Oxygen — p=0.0012
N/A N=1,493 A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation
Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies
Primary: Duration of Invasive Mechanical Ventilation — 6.3; 7.8; 7.3 day
N/A N=70 Supplemental Oxygen Study
Cesarean Section · Supplemental Oxygen · Umbilical Cord Gases
Primary: Umbilical Cord pH Levels — 7.29; 7.28 pH
N/A N=860 Umbilical Cord Milking in Non-Vigorous Infants
Birth Asphyxia
Primary: Number of Neonatal Participants Admitted to the NICU for Predefined Criteria — 199; 239; 53; 52 Participants — p=.87
N/A N=3,003 Impact of Heart Rate Characteristics Monitoring in Neonates
Sepsis
Primary: Number of Ventilator-free Days — 95.9; 93.6 days — p=0.08
N/A N=103 Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
Respiratory Distress Syndrome
Primary: Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. — 34; 19 Participants — p=0.006
N/A N=40 Pre-Oxygenation Techniques in Pregnancy
Preoxygenation
Primary: End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow — 91.0; 87.4 Percentage units of end-tidal oxygen
N/A N=200 Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
Prematurity · Respiratory Distress Syndrome
Primary: Need for Endotracheal Ventilation in the First 72 hs of Life — 34; 25 participants — p=<0.05
N/A N=4,231 Circulation Improving Resuscitation Care (CIRC)
Cardiac Arrest · Cardiopulmonary Resuscitation
Primary: Hospital Discharge — 196; 233 participants
N/A N=340 NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
Preterm Infants
Primary: Number of Participants Who Required Intubation — 26; 15 Participants
Phase 2 N=123 A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
Respiratory Distress Syndrome, Newborn
Primary: Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio — 3.33; 3.31; 3.36; 3.55 SpO2/FiO2 ratio — p=0.930
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
N/A N=62 The Impact of Pedagogical Framework in Education of Neonatal Resuscitation
Nursing Students Education on Neonatal Resuscitation
Primary: Knowledge Questionnaire — 5.90; 5.87; 9.97; 13.33 score on a scale