Phase 3 N=500 High-dose Erythropoietin for Asphyxia and Encephalopathy
Neonatal Encephalopathy · Birth Asphyxia
Primary: Number of Participants With Death or Neurodevelopmental Impairment — 126; 110 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=111 Cerebral Oxygenation and Autoregulation in Preterm Infants
Intraventricular Hemorrhage of Prematurity · Complications of Prematurity
Primary: Mortality Before Hospital Discharge — 11 Participants
N/A N=325 TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Asphyxia Neonatorum · Hypoxia · Encephalopathy
Primary: Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors — 74; 86 participants
N/A N=29 Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
Hypoplastic Left Heart Syndrome · Total Anomalous Pulmonary Venous Return · Truncus Arteriosus
Primary: Systemic Oxidative Stress Based on Thiobarbituric Acid Reactive Substances (TBARS) — 1.21; 1.93; 1.09; 1.77 Fold Change from Baseline — p=<0.01
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=92 Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Hypoxic Ischaemic Encephalopathy
Primary: Lactate (Lac) / N Acetyl Aspartate (NAA) Ratio on Magnetic Resonance Spectroscopy — 0.25; 0.28 ratio
N/A N=63 Neonatal Resuscitation - Sustained Inflations
Premature Birth
Primary: Expiratory Tidal Volume — 153; 194 ml/kg/min
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
N/A N=212 Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Intrauterine Resuscitation
Primary: Umbilical Artery Malondialdehyde — 9.8; 10.2 umol/L
Phase 2 N=50 Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic Encephalopathy · Neonatal Encephalopathy · Birth Asphyxia
Primary: Markers of Organ Function — 10; 6; 9; 12 participants
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=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=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
N/A N=24 Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery · Inflammatory Reaction After Neonatal Cardiac Surgery
Primary: Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) — 0.46; 0.64; 11.52; 26.98 ng/ml — p=>0.05
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=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=168 Preemie Hypothermia for Neonatal Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain
Primary: Death or Moderate or Severe Disability — 29; 20 Participants
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=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=48 NICU Oxygen Control Study
Hyperoxia · Hypoxia
Primary: Elapsed Time to Respond to SpO2 Alarm — 51.408; 41.523 seconds — p=0.003
N/A N=168 Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain
Primary: Death or Moderate or Severe Disability — 19; 22 Participants
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
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
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
N/A N=7 Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates
Deglutition Disorders · Respiratory Distress Syndrome In Premature Infants · Respiratory Aspiration
Primary: Pharyngeal Phase Dysphagia — 7; 7 Participants
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
Phase 3 N=1,316 Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Infant, Newborn, Diseases · Other Preterm Infants · Infant, Small for Gestational Age
Primary: Survival Without Bronchopulmonary Dysplasia (BPD) — 346; 320 Participants
Phase 3 N=173 Premedication Trial for Tracheal Intubation of the NEOnate
Premedication · Endotracheal Intubation
Primary: Number of Patients With Prolonged Desaturation — 54; 53 Participants — p=0.38
N/A N=165 NICU Asthma Education and Secondhand Smoke Reduction Study
Respiratory Illness
Primary: Infants Living in Smoke-free Environments. — 65; 64 participants