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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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=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
N/A N=203 BiliCam Clinical Validation Study
Newborn Jaundice
Primary: BCB - TSB Correlation — 0.82 correlation coefficient — p=<.001
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
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…
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
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
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=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 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=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
N/A N=79 Glycerin Suppositories to Reduce Jaundice in Premature Infants
Idiopathic Hyperbilirubinemia · Neonatal Hyperbilirubinemia · Prematurity
Primary: Total Number of Hours of Required Phototherapy — 72; 61 hours
N/A N=44 Characterization of Pre-Term Neonatal Skin
Skin Disorder
Primary: Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek — 0.814386451; 0.85422779; 0.67588721; 0.79293382 Correlation Coefficient…
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
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…
N/A N=136 Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
Parenteral Nutrition-Associated Liver Disease
Primary: The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer. — 39; 45 participants who developed Cholestasis
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=150 Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Iron Deficiency Anemia
Primary: Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) — 29.2; 28.2 % Hematocrit — p=0.59
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=30 Intra-Abdominal Hypertension in Neonatal Intensive Care Patients
Intra-Abdominal Hypertension
Primary: Intra-abdominal Pressure(IAP) Measurements in NICU Patients. — 1219 IAP measurements
Phase 4 N=52 Early Sodium Intake in Preterm Newborns
Hyponatremia · Premature
Primary: Hyponatremia — 6; 1 Participants — p=0.71
N/A N=21 Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
Neonatal Hypoglycemia
Primary: Sensor-detected Hypoglycemia — 5; 1 events
N/A N=65 Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants
Preterm Infant · Early-Onset Neonatal Sepsis · Umbilical Cord
Primary: White Blood Cell Count (WBC) (1) — 8257 ratio of cells/mm3
N/A N=146 Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
Very Preterm Maturity of Infant · The Risk Factors for Improving the Prognosis of VLBW Infants
Primary: The Incidence of Early Onset Sepsis in VLBW Infants With AOP. — 18; 34; 7; 42 Participants
Phase 3 N=48 Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Cholestasis of Parenteral Nutrition
Primary: Number of Participants With Cholestasis — 1; 3; 7 Participants — p=0.590
Phase 2 N=30 Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
Biliary Atresia
Primary: Feasibility of IVIG Treatment — 23 Participants
Phase 3 N=150 Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
Anemia
Primary: Hematocrit (Hct) — 29.2; 28.3 percentage of red blood cells in blood
N/A N=48 Very Low Birth Weight Preterm Infant Bundled Care in the NICU
Preterm Infants
Primary: Mean Heart Rate by Group — 200; 185 beats per minute