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=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=39 ABCA3 Gene and RDS in Late Preterm and Term Infants
Respiratory Distress Syndrome, Newborn
Primary: Mortality — 5; 3; 5 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=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=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 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
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=270 Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants
Bronchopulmonary Dysplasia
Primary: Respiratory Adverse Outcomes — 27; 60 Participants
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
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 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
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 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=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 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 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)
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=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 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=360 NHFOV as Primary Support in Very Preterm Infants With RDS
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
Primary: Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation — 48; 27 Participants
Phase 2 N=221 The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
Respiratory Distress Syndrome
Primary: Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) — 31; 32; 31 Participants — p=0.363
Phase 3 N=800 Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
Lung Disease
Primary: Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress — 258; 262 Participants — p=0.7340
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=40 Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass
Heart Disease Congenital Complex
Primary: Incidence of Low Cardiac Output Syndrome (LCOS) — 57; 26 percentage of patients — p=0.049
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
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
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
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