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
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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
N/A N=39 ABCA3 Gene and RDS in Late Preterm and Term Infants
Respiratory Distress Syndrome, Newborn
Primary: Mortality — 5; 3; 5 Participants
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
Phase 2 N=18 Early Insulin and Development of ARDS
Respiratory Distress Syndrome, Adult · Sepsis · Hyperglycemia
Primary: Plasma Levels of Free Fatty Acids, Tumor Necrosis Factor-α, Interleukin-6, and Von Willebrand Factor Antigen
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=30 Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
Respiratory Distress Syndrome
Primary: Change From Baseline in Blood C-reactive (CRP) Protein — 1.300; 0.193 mg/dL — p=<.05
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
Phase 3 N=124 NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)
RDS of Prematurity
Primary: Duration of NIV Support — 89; 87 HOURS — p=< 0.05
Phase 3 N=477 Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Respiratory Distress Syndrome
Primary: Intubation and Instillation of Liquid Surfactant — 69; 120 Participants
Phase 3 N=88 A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
Respiratory Distress Syndrome
Primary: The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration…
N/A N=270 Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants
Bronchopulmonary Dysplasia
Primary: Respiratory Adverse Outcomes — 27; 60 Participants
Phase 3 N=52 Nitric Oxide Administration for Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome
Primary: Mean PaO2/FiO2 Ratio — 115.6; 115.9 mmHg — p=>0.05
Phase 2 N=88 Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome
Respiratory Distress Syndrome in Premature Infant · Bronchopulmonary Dysplasia
Primary: Survival Without Evidence of Chronic Pulmonary Insufficiency of Prematurity (CPIP) at 12 Months Corrected Gestational Age (CGA) — 8; 2; 6; 6 Number of events
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
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=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
N/A N=34 Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Bronchopulmonary Dysplasia
Primary: Number of Days Being Intubated — 12.4; 6.2 days
Phase 2 N=124 Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Bronchopulmonary Dysplasia
Primary: Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality — 1; 2; 24; 25 Participants
Phase 3 N=85 Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) · Bronchopulmonary Dysplasia
Primary: SP-B Content — 19.9; 13.3 Total surfactant protein (% of PL)
Phase 2 N=80 Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Respiratory Distress Syndrome
Primary: Peri-Dosing Events — 0; 0; 0; 1 participants
N/A N=513 Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome
Primary: 28 Day Mortality in Pediatric ARDS. — 44 Participants — p=<0.05
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=82 Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection
Respiratory Syncytial Virus Infection
Primary: Number of Hospital Admissions by Respiratory Syncytial Virus Infection — 2 participants
Phase 4 N=14 Preterm Infant Inhaled Albuterol Dosing
Bronchopulmonary Dysplasia · Very Low Birth Weight
Primary: Change in Respiratory Resistance — 0.011; 0.006; 0.014 cm h2o/mL/sec
N/A N=2,401 A Prospective, Epidemiological Study to Assess the Disease Burden of Respiratory Syncytial Virus Associated, Suspected Lower Respiratory Tract Infections in Newborns, From 0 to 2 Years of Age and Risk of Development of Wheeze and Asthma From 0 to 6 Years of Age
Respiratory Syncytial Virus
Primary: Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1] — 7.93 Cases per 100 person-years
N/A N=20 Relationship Between EIT and Respiratory Status in Very Preterm Infants
Chronic Lung Disease of Prematurity · Bronchopulmonary Dysplasia · Premature Lungs
Primary: EIT Metric Global Inhomogeneity Index at 31 Weeks Post Menstrual Age in Those Successful in Discontinuation of Non-invasive Ventilation at 32 Weeks Post Menstrual Age…
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
Phase 2 N=165 Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Acute Hypoxemic Respiratory Failure
Primary: Duration of Mechanical Ventilation Through 14 Days — 4.0; 4.5 days
N/A N=63 Neonatal Resuscitation - Sustained Inflations
Premature Birth
Primary: Expiratory Tidal Volume — 153; 194 ml/kg/min