Phase 4 N=60 Heart Rate Response to Atropine Doses Less Than 0.1mg IV to Anesthetized Infants
Bradycardia · Arrhythmias
Primary: Incidence of Bradycardia — 0; 0 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=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=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
Phase 4 N=21 Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Caffeine
Primary: Intubation — 3; 7 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=19 Non-invasive Intervention for Apnea of Prematurity
Apnea of Prematurity · Hypoxia · Bradycardia
Primary: Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention — 284.13; 174.27 breathing pauses
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
Phase 4 N=223 Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
Apnea · Apnea Neonatal · Prematurity
Primary: Occurrence of Apnea — 25; 12; 80; 104 Participants — p=0.0104
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=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=10 Skin to Skin and Heart Rate Variability
Heart Rate Variability · Preterm Infant
Primary: Heart Rate Variability — 9.68 ms
N/A N=63 Prospective Research in Infants With Mild Encephalopathy
Hypoxic-Ischemic Encephalopathy · Brain Injury · Neonatal Seizure
Primary: Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality. — 28 Participants
N/A N=25 Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
Post-Op Complication
Primary: Infants With Elevated s100b and NSE — 11; 9 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 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
N/A N=245 Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Acute Kidney Injury · Hypoxia-Ischemia, Brain · Mesenteric Ischemia
Primary: Number of Participants With Acute Kidney Injury — 18; 57 Participants
Phase 3 N=295 Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
Cardiac Arrest
Primary: Survival With Good Neurobehavioral Outcome — 27; 15; 111; 107 Participants — p=0.14
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=329 Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
Cardiac Arrest
Primary: Survival With Good Neurobehavioral Outcome — 48; 48; 85; 76 Participants — p=0.63
N/A N=70 Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants
Hypotension
Primary: Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life — 9; 9 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=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=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
Phase 2 N=62 Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Congenital Heart Disease · Hypoplastic Left Heart Syndrome · Transposition of the Great Arteries
Primary: Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI — 12.1; 9.44 Percentage
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=10 Holding, Stress, and Bonding During Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Primary: Frequency of Adverse Events (Safety) — 0 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=20 Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
Body Temperature
Primary: Mean Axillary Admission Temperature — 36.77; 36.68 Degrees Celsius — p=0.7294