Clinical trials: Neonatal Screening
Implementation Science, Informed Consent
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening
The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on…
- Conditions
- Implementation Science, Informed Consent, Neonatal Screening
- Trial name
- MICI (NCT06192511)
- Testing
- Educational Website and Video
- Where
- 2 sites in United States
- Volunteers
- 5,980 people, healthy volunteers welcome
- Sponsor
- Erin Rothwell
Jaundice, Neonatal, Neonatal Diseases and Abnormalities
Evaluation of Bili-ruler, a Low-cost, Plastic Icterometer for Community-based Screening of Jaundice in Newborns
Newborn jaundice, or accumulation of bilirubin molecules in blood, affects 60-80% of newborns and, in severe cases, places newborns at risk of brain damage and death.
- Conditions
- Jaundice, Neonatal, Neonatal Diseases and Abnormalities, Neonatal Hyperbilirubinemia, Screening Tool
- Trial name
- NCT06687746
- Testing
- Bili-ruler
- Where
- 5 sites in India, Kenya and 2 more
- Volunteers
- 4,060 people, healthy volunteers welcome
- Sponsor
- George Washington University
Neonatal Screening, Lysosomal Storage Diseases
A Pilot Study for Systematic Neonatal Screening for Lysosomal Storage Diseases Using Tandem Mass Spectrometry
The study will include all newborns in Normandie region for 3 years (about 105,000 births) for whom signed consent by one (or two) parents will be collected.
- Trial name
- LysoNeo (NCT04393701)
- Testing
- Additional blood sampling
- Where
- 2 sites in France
- Volunteers
- 100,000 people
- Sponsor
- University Hospital, Rouen
Neonatal Screening, Kernicterus
Bilistick Point-of-care System 2.0 Bilirubin Validation
This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected…
- Conditions
- Neonatal Screening, Kernicterus, Newborn Jaundice, Point-of-Care Testing
- Trial name
- NCT06058910
- Testing
- Bilistick System 2.0 point-of-care testing device
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Kettering Health Network
Feasibility of Neonatal Screening for Spinal Amyotrophy
Feasibility of a Newborn Screening for Spinal Muscular Atrophy (SMA) in France: DEPISMA Prefigurator Project in Grand-Est and Nouvelle-Aquitaine
Spinal muscular atrophy (SMA) is a genetic disease of the nervous system that affects about 1 in 7,0001.2 births and results in very high mortality for patients with the disease.
- Trial name
- DEPISMA (NCT05645250)
- Where
- 39 sites in France
- Volunteers
- 220,000 people
- Sponsor
- University Hospital, Strasbourg, France
Severe Combined Immunodeficiency, Neonatal Screening
Neonatal Screening of Severe Combined Immunodeficiencies
The goal of the proposed research is to observe the prevalence and establish the validity of a newborn screening method for severe combined immunodeficiency (SCID).
- Trial name
- NCT02590328
- Where
- China
- Volunteers
- 180,000 people
- Sponsor
- Children's Hospital of Fudan University
Neonatal Screening
The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research
Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research.
- Trial name
- EICI (NCT03141307)
- Testing
- EICI Movie, EICI App, Control
- Where
- United States
- Volunteers
- 711 people, healthy volunteers welcome
- Sponsor
- University of Utah
Newborn, Neonatal Screening
Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking
The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants.
- Trial name
- BBSUCROSE (NCT02374281)
- Testing
- Glucose sucking, Water sucking, No sucking
- Where
- France
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Neonatal Screening
Parent Education and Choice About Newborn Screening and Bloodspot Retention
To address the content, timing, efficacy, and impact of prenatal education about newborn screening generally and sample retention specifically.
- Trial name
- NCT02676245
- Testing
- Viewing Newborn Screening movie, Viewing Residual Dried Blood Spot movie
- Volunteers
- 664 people
- Sponsor
- University of Utah
Prematurity, Neonatal Screening
Amino Acid and Acylcarnitine Profiles in Premature Neonates
Primary Hypotheses of the study include: Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness Metabolic profiles differ between neonates who receive…
- Conditions
- Prematurity, Neonatal Screening, Parenteral Nutrition
- Trial name
- NCT00865150
- Where
- 2 sites in United States
- Volunteers
- 1,003 people, healthy volunteers welcome
- Sponsor
- Pediatrix