N/A N=624 Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
Hyperbilirubinemic Encephalopathy
Primary: Bilirubin Induced Neurologic Dysfunction II Score (BIND II) — 1 units on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=430 Implementation of a Transcutaneous Bilirubinometer
Neonatal Jaundice · Hyperbilirubinemia
Primary: Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). — 0; 1 blood tests for bilirubin
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
Phase 4 N=92 Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
Hyperbilirubinemia · Erythroblastosis, Fetal
Primary: Need of Exchange Transfusion — 6; 7 participants — p=0.765
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
Phase 2 N=91 Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
Jaundice, Neonatal · Hyperbilirubinemia, Neonatal
Primary: Total Serum Bilirubin (mg/dL) — 9.82; 9.97; 9.92; 8.48 mg/dL — p==0.0000021
Phase 2 N=28 Mild Encephalopathy in the Newborn Treated With Darbepoetin
Neonatal Encephalopathy · Hypoxic-Ischemic Encephalopathy Mild
Primary: Normal Neurodevelopment — 13; 14 Participants
Phase 3 N=1 CEUS Evaluation of Hypoxic Ischemic Injury
Hypoxic-Ischemic Encephalopathy · Brain Ischemia Hypoxia
Primary: Detection of Brain Perfusion Abnormalities Using Contrast-enhanced Ultrasound — 1; 0 Participants
N/A N=103 Transcutaneous Bilirubinometry in Neonates With Bilicare System
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Primary: BiliCare TcB Result Compared to TSB Result — 8.46; 7.93; 7.83 mg/dL
N/A N=77 Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Prematurity
Primary: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function — 79; 91; 103; 83 standardized score on a scale
N/A N=113 Transcutaneous Bilirubinometry in Neonates With the Bilicare System
Transcutaneous Bilirubinometry
Primary: In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48…
N/A N=111 Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Primary: BiliCare TcB Result Compared to TSB Result — 8.0; 7.3 mg/dL
Phase 1 N=21 A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
Primary: Change in Brachial Artery Diameter — -0.93 percentage of dilation
Phase 3 N=941 Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)
Extreme Prematurity
Primary: Number of Participants With Death or Severe Neurodevelopmental Impairment (NDI) at 22-26 Months Corrected Age — 94; 97 Participants — p=0.05
N/A N=174 Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates
Jaundice, Neonatal
Primary: Efficacy of Phototherapy — 116; 135 treatment days
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
Phase 4 N=66 The Effect of Lipid Emulsions on Free Fatty Acids and Free Bilirubin in Premature Newborns
Prematurity
Primary: Free Bilirubin (UB) Serum Levels — 10.5; 9.4 Nanomoles/Liter (nM)
N/A N=203 BiliCam Clinical Validation Study
Newborn Jaundice
Primary: BCB - TSB Correlation — 0.82 correlation coefficient — p=<.001
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
Phase 2 N=256 Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
Intraventricular Hemorrhage · Periventricular Leukomalacia · Brain Injury
Primary: Percent of Survivors With no Severe IVH (Grades 3 or 4) or PVL — 22.2; 14.9; 17.1; 10.9 percent of participants
Phase 2 N=13 N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy
Biliary Atresia
Primary: Number of Patients With Biliary Atresia (BA) Achieving Total Serum Bile Acids Less Than or Equal to 10 *U*Mol/L Within 24 Weeks of Kasai Portoenterostomy (KP) — 0…
Phase 2 N=231 Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
Acute Episode of Overt Hepatic Encephalopathy · Hepatic Encephalopathy
Primary: Percentage of Participants in Each HE Stage — 11; 6; 30; 40 percentage of participants
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 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=99 Breastfeeding Support Intervention in Jaundiced Infants
Jaundice · Breastfeeding
Primary: Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely — 22; 24 Participants — p=0.40
Phase 3 N=40 Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
Parenteral Nutrition Associated Cholestasis
Primary: Number of Participants With Parenteral Nutrition Associated Cholestasis — 6; 6 Participants — p=0.94
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=447 Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
Jaundice, Neonatal
Primary: Safety of Phototherapy — 268; 325 treatment days
Phase 3 N=256 Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy
Primary: Death — 27; 22 participants