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=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=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=212 Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Intrauterine Resuscitation
Primary: Umbilical Artery Malondialdehyde — 9.8; 10.2 umol/L
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=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=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=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=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
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=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=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=63 Neonatal Resuscitation - Sustained Inflations
Premature Birth
Primary: Expiratory Tidal Volume — 153; 194 ml/kg/min
Phase 2 N=30 Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Hypoxic Ischemic Encephalopathy
Primary: The Pharmacokinetic Profile of Darbe After the First Dose During Cooling — 180,866; 26,555 AUC (h*mU/L) — p=0.006
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
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 1 N=9 Caffeine for Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy
Primary: Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine — 1137.36; 1177.94; 2213.26; 2768.25 mg*hr/L
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=72 Positive Pressure at Induction of Anesthesia in Children
Continuous Positive Airway Pressure · Hypoxia · General Anesthesia
Primary: Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels — 227.65; 133.68 seconds — p=<0.0001
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
Phase 2 N=35 A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
Primary: Survival at One Year — 16; 17 Participants
N/A N=21 Measuring Brain Activity of School Age Children
Perinatal Hypoxia · Dopamine · Neurobehavioral Manifestations
Primary: Structural Integrity of Dopaminergic Circuits — 148.90; 175.93; 177.25; 192.78 mm^3
N/A N=995 Neonatal Outcome by Reason for Delivery
Preterm Delivery
Primary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
Phase 3 N=98 Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Hypoxia
Primary: Episodes of Intermittent Hypoxia Per Hour — 3.6; 8.4; 3.8; 8.2 Events per hour — p=<0.05
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)
N/A N=280 The TOBY Children Study
Cerebral Palsy · Hypoxia-Ischemia, Brain
Primary: Number of Survivors With an IQ > 84 — 75; 52 participants
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=21 Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Caffeine
Primary: Intubation — 3; 7 participants
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=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