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
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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=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=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
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…
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
Phase 2 N=102 Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
Traumatic Brain Injury · Subarachnoid Hemorrhage · Intracerebral Hemorrhage
Primary: Number of Units of Packed Red Blood Cell Transfused — 0.9; 1.5 units — p=0.03
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=21 Use of NIRS in Preterm Population Born at Altitude
Prematurity; Extreme
Primary: Cerebral Regional Oxygen Saturation (cRSO2) — 73.4 percent rcSO2
N/A N=49 Temporal Artery Temperature Measurement in Neonates
Newborn Infant
Primary: Temporal Artery Temperature — 37.16 degrees Celsius
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=162 Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates
Diabetes
Primary: Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value — 100.0; 99.5; 99.5 percentage of…
N/A N=35 NIRS Monitoring to Detect AKI in Preterm Infants
Acute Kidney Injury · Premature Infant
Primary: Renal NIRS Tissue Oxygenation Differential — 60; 32.4; 62.5; 44.4 percentage saturation — p=<0.001
N/A N=65 Continuous Non-Invasive Measurement of Hemoglobin During Parturition
Hemorrhage · Cesarean Section
Primary: Pearson Correlation Coefficient for Hemoglobin Measurements — 0.6 Correlation Coeficient
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=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
N/A N=94 A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters
Anemia · Diabetes · Heart Disease
Primary: Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. — 0.6; 7.9; 7.5; 2.33 percentage of error
N/A N=32 Validation of Next Generation Cerebral and Tissue Oximeter
Oxygen Deficiency
Primary: Validated the Next Generation Oximeter — 1.22; 0.83; 0.09 Percentage saturation
N/A N=154 Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion
Acute Scrotum · Testicular Torsion
Primary: Median NIRS Delta %StO2 — 2.0; -1.7 percentage of StO2
N/A N=20 Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test
Healthy
Primary: Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved — 17.9; 13.5; 280.0; 186.5 %/min — p=<0.05
N/A N=117 U-TruSignal SpO2 Testing in Neonates
Pulse Oximetry
Primary: Accuracy Root Mean Square (ARMS) Per Data Pair — 2.57; 2.57 percentage of oxygen saturated hemoglobi
N/A N=120 Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples
Diabetes Mellitus
Primary: Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values — 240 blood samples
N/A N=1,824 Transfusion of Prematures Trial
Infant, Newborn, Diseases · Infant, Extremely Low Birth Weight · Infant, Small for Gestational Age
Primary: Death or Neurodevelopmental Impairment — 423; 422; 422; 425 Participants — p=0.93
N/A N=10 Transmitted Light Tissue Thickness Analysis (TiLTT)
Morbid Obesity
Primary: Number of Patients With Transmitted Light Intensity to Gastric Wall Thickness) — 10 Participants
N/A N=110 Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract
Childhood Cataract
Primary: Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard — 17; 54; 32; 7 eyes
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=49 Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
Delivery Room Resuscitation
Primary: PCO2 Level Outside of Desired Range (40-60 mmHg) — 9; 8 participants
N/A N=82 Accuracy of the NICCI™ Monitor in Children and Adolescents
Surgery · Anesthesia
Primary: Difference in Blood Pressure — 11; 10; 10; 9 mm Hg