N/A N=81 Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Autism Spectrum Disorder
Primary: ABR Peak V Latency — 6; 5.8; 6.29; 5.99 ms
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=106 North Carolina Newborn Exome Sequencing for Universal Screening
Metabolism, Inborn Errors · Hearing Loss · Hereditary Disease
Primary: Parental Choices Following Decision Aid — 120; 57; 25; 2 Participants
N/A N=100 Caring for Babies During the Newborn Screening Blood Test
Pain
Primary: Pain Management Used During Newborn Screening Blood Test — 30; 33 Participants
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=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
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=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=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=50 Pocket Echocardiography System (PES) for Detection of PDA in Neonates
Patent Ductus Arteriosus
Primary: False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES) — 10.8 percentage of…
N/A N=500 Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
Chlamydia Trachomatis Infection · Neonatal Infection · Preterm Birth
Primary: Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery — 2; 23 Participants
N/A N=28 Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach
Sickle Cell Trait
Primary: Acceptability — 11; 8; 11; 8 Participants
N/A N=477 South-seq: Deoxyribonucleic Acid (DNA) Sequencing for Newborn Nurseries in the South
Whole Genome Sequencing
Primary: Evaluate Parental Empowerment Using the Genetic Counseling Outcome Scale (GCOS) — 117.94; 117.19 score on a scale
N/A N=70 NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy
Cerebral Palsy · Prematurity · Early Intervention
Primary: Acceptability — 70 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=410 Monitoring Neonatal Resuscitation Trial
Resuscitation · Neonatal Prematurity · Positive-Pressure Respiration
Primary: Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg — 30.2; 30.7 percentage of inflations — p=0.896
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=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=970 Genomic Sequencing for Childhood Risk and Newborn Illness
Hereditary Disease · Genetic Predisposition to Disease
Primary: Downstream Health Care Costs Attributable to BabySeq Project Disclosure: Days of Inpatient Care — 0.1; 0.0; 3.1; 3.8 Days
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=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=813 Third Trimester Screening of Fetal Growth Restriction
Fetal Growth Retardation · Fetal; Slow Growth
Primary: Rate of Small for Gestational Age at Birth Identified Antenatally — 28; 46 Participants
N/A N=23 Neonatal Pulse Oximetry Sensor Study
Premature Birth
Primary: Bland-Altman Analysis for Nellcor Pulse Oximeter — .151; .434 percentage of difference in mean
N/A N=400 Genomic Medicine for Ill Neonates and Infants (The GEMINI Study)
Pediatric: Genetic Syndrome
Primary: The Number of Subjects With a Confirmed Genetic Disorder Detected by NewbornDx — 109 Participants
Phase 2 N=28 Mild Encephalopathy in the Newborn Treated With Darbepoetin
Neonatal Encephalopathy · Hypoxic-Ischemic Encephalopathy Mild
Primary: Normal Neurodevelopment — 13; 14 Participants
N/A N=97,507 Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Neonatal Death · Prematurity
Primary: Use of Parenteral Nutrition (Project A) — 62145 Participants
N/A N=4,488 National Prevalence and Impact of Noninvasive Prenatal Testing
Aneuploidy
Primary: Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market — 1414; 3074 Participants
N/A N=50 Oxygen Saturation Alarms in the Neonatal Intensive Care Unit
Hypoxemia
Primary: Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. — 39.9; 44.4; 48.0; 50.3 percentage of interventions
N/A N=301 Vestibular Infants Screening-Flanders
Vestibular Disorder · Hearing Impaired Children
Primary: Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results. — 35 Participants
Phase 1 N=44 Intestinal Permeability in Preterm Infants
Prematurity · Intestinal Permeability
Primary: Intestinal Permeability — 0.0731; 0.0720 ratio — p=0.932