ClinicalTrials.gov record
Early Check: Expanded Screening in Newborns
ClinicalTrials.gov ID: NCT03655223
Public ClinicalTrials.gov record NCT03655223. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 21, 2026, 1:11 AM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns
Study identification
- NCT ID
- NCT03655223
- Recruitment status
- Enrolling by invitation
- Study type
- Observational
- Phase
- Not listed
- Lead sponsor
- RTI International
- Other
- Enrollment
- 30,000 participants
Conditions and interventions
Conditions
- 17 Alpha-Hydroxylase Deficiency
- 3-Hydroxy-3-Methylglutaric Aciduria
- 3-Hydroxyacyl-CoA Dehydrogenase Deficiency
- 3-Methylcrotonyl CoA Carboxylase 1 Deficiency
- 3-Methylcrotonyl CoA Carboxylase 2 Deficiency
- 3-Phosphoglycerate Dehydrogenase Deficiency
- Acrodermatitis Enteropathica
- Adenine Phosphoribosyltransferase Deficiency
- Adrenocorticotropic Hormone Deficiency
- Adrenoleukodystrophy, Neonatal
- Agat Deficiency
- Alport Syndrome, Autosomal Recessive
- Alport Syndrome, X-Linked
- Angelman Syndrome
- Apparent Mineralocorticoid Excess
- Argininosuccinic Aciduria
- Ataxia With Isolated Vitamin E Deficiency
- Autosomal Recessive Nonsyndromic Hearing Loss
- Barth Syndrome
- Beta-Thalassemia
- Beta-ketothiolase Deficiency
- Biotin-Responsive Basal Ganglia Disease
- Biotinidase Deficiency
- CBAS1
- Canavan Disease
- Carbamoyl Phosphate Synthetase I Deficiency Disease
- Carbonic Anhydrase VA Deficiency
- Carnitine Palmitoyl Transferase 1A Deficiency
- Carnitine Palmitoyltransferase II Deficiency
- Carnitine-acylcarnitine Translocase Deficiency
- CblF
- Central Hypoventilation Syndrome With or Without Hirschsprung Disease
- Cerebrotendinous Xanthomatoses
- Chronic Granulomatous Disease
- Citrullinemia, Type I
- Combined Immunodeficiency Due to ZAP70 Deficiency
- Congenital Bile Acid Synthesis Defect Type 2
- Congenital Disorder of Glycosylation Type 1B
- Congenital Hypothyroidism
- Congenital Isolated Thyroid Stimulating Hormone Deficiency
- Congenital Lipoid Adrenal Hyperplasia Due to STAR Deficiency
- Creatine Transporter Deficiency
- Cystic Fibrosis
- Cystinosis
- DIAR1
- Developmental and Epileptic Encephalopathy 2
- Diabetes Mellitus
- Diabetes Mellitus, Permanent Neonatal
- Diabetes Mellitus, Permanent Neonatal, With Neurologic Features
- Dihydropteridine Reductase Deficiency
- Dravet Syndrome
- Duchenne Muscular Dystrophy
- Epilepsy, Early-Onset, Vitamin B6-Dependent
- Factor VII Deficiency
- Factor X Deficiency
- Fragile X - Premutation
- Fragile X Syndrome
- Fructose 1,6 Bisphosphatase Deficiency
- G6PD Deficiency
- GSD1C
- Galactokinase Deficiency
- Galactosemias
- Glucose Transporter Type 1 Deficiency Syndrome
- Glutaryl-CoA Dehydrogenase Deficiency
- Glutathione Synthetase Deficiency
- Glycogen Storage Disease IC
- Glycogen Storage Disease II
- Glycogen Storage Disease IXB
- Glycogen Storage Disease IXC
- Glycogen Storage Disease Type I
- Glycogen Storage Disease Type IB
- Glycogen Storage Disease Type IXA1
- Glycogen Storage Disease, Type IXA2
- Gtp Cyclohydrolase I Deficiency
- Guanidinoacetate Methyltransferase Deficiency
- HSDB
- Hemophilia A
- Hemophilia B
- Hereditary Fructose Intolerance
- Hereditary Hypophosphatemic Rickets
- Hermansky-Pudlak Syndrome 1
- Hermansky-Pudlak Syndrome 4
- Holocarboxylase Synthetase Deficiency
- Homocystinuria
- Hyperargininemia
- Hyperinsulinemic Hypoglycemia, Familial 1
- Hyperinsulinemic Hypoglycemia, Familial, 2
- Hyperinsulinism-Hyperammonemia Syndrome
- Hypophosphatasia
- Hypothyroidism Due to TSH Receptor Mutations
- Intrinsic Factor Deficiency
- Isovaleric Acidemia
- Jervell and Lange-Nielsen Syndrome 1
- Jervell and Lange-Nielsen Syndrome 2
- Krabbe Disease
- Leber Congenital Amaurosis 2
- Liddle Syndrome
- Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency
- Lysosomal Acid Lipase Deficiency
- MAHCD
- MOWS
- Maple Syrup Urine Disease, Type 1A
- Maple Syrup Urine Disease, Type 1B
- Maple Syrup Urine Disease, Type 2
- Medium-chain Acyl-CoA Dehydrogenase Deficiency
- Menkes Disease
- Metachromatic Leukodystrophy
- Methylcobalamin Deficiency Type Cbl G (Disorder)
- Methylcobalamin Deficiency Type cblE
- Methylmalonic Aciduria Due to Methylmalonyl-CoA Mutase Deficiency
- Methylmalonic Aciduria and Homocystinuria Type cblC
- Methylmalonic Aciduria cblA Type
- Methylmalonic Aciduria cblB Type
- Mitochondrial Trifunctional Protein Deficiency
- Molybdenum Cofactor Deficiency, Type A
- Mthfr Deficiency
- Mucopolysaccharidosis Type 1
- Mucopolysaccharidosis Type 2
- Mucopolysaccharidosis Type 3 A
- Mucopolysaccharidosis Type 6
- Mucopolysaccharidosis Type 7
- Mucopolysaccharidosis Type IV A
- Multiple Endocrine Neoplasia Type 2B
- N-acetylglutamate Synthase Deficiency
- Neonatal Severe Primary Hyperparathyroidism
- Niemann-Pick Disease Type A
- Niemann-Pick Disease Type C2
- Niemann-Pick Disease, Type C1
- Ornithine Aminotransferase Deficiency
- Ornithine Transcarbamylase Deficiency
- Ornithine Translocase Deficiency
- Pancreatic Agenesis 1
- Permanent Neonatal Diabetes Mellitus
- Phenylketonurias
- Pitt Hopkins Syndrome
- Pituitary Hormone Deficiency, Combined, 1
- Prader-Willi Syndrome
- Primary Hyperoxaluria Type 1
- Primary Hyperoxaluria Type 2
- Primary Hyperoxaluria Type 3
- Propionic Acidemia
- Pseudohypoaldosteronism, Type I
- Ptsd
- Pyridoxal Phosphate-Responsive Seizures
- Pyridoxine-Dependent Epilepsy
- Retinoblastoma
- Rett Syndrome
- Riboflavin Transporter Deficiency
- SCD
- SRD
- Segawa Syndrome, Autosomal Recessive
- Severe Combined Immunodeficiency Due to Adenosine Deaminase Deficiency
- Severe Combined Immunodeficiency Due to DCLRE1C Deficiency
- Severe Combined Immunodeficiency Due to IL-7Ralpha Deficiency
- Severe Combined Immunodeficiency Due to RAG1 Deficiency
- Severe Combined Immunodeficiency Due to RAG2 Deficiency
- Severe Combined Immunodeficiency T-Cell Negative B-Cell Positive Due to Janus Kinase-3 Deficiency (Disorder)
- Severe Combined Immunodeficiency, X Linked
- Sickle Cell Disease
- Smith-Lemli-Opitz Syndrome
- Spinal Muscular Atrophy
- Stickler Syndrome Type 1
- Stickler Syndrome Type 2
- Supravalvar Aortic Stenosis
- Thyroid Dyshormonogenesis 1
- Thyroid Dyshormonogenesis 2A
- Thyroid Dyshormonogenesis 3
- Thyroid Dyshormonogenesis 5
- Thyroid Dyshormonogenesis 6
- Transcobalamin II Deficiency
- Transient Neonatal Diabetes Mellitus
- Tuberous Sclerosis 1
- Tuberous Sclerosis 2
- Tyrosinemia, Type I
- Usher Syndrome Type 1C
- Usher Syndrome Type 1D/F Digenic (Diagnosis)
- Usher Syndrome Type 1G (Diagnosis)
- Usher Syndrome, Type 1B
- Usher Syndrome, Type 1F
- Very Long Chain Acyl Coa Dehydrogenase Deficiency
- Von Willebrand Disease, Type 3
- Waardenburg Syndrome Type 1
- Waardenburg Syndrome Type 2A
- Waardenburg Syndrome, Type 2E
- Wilson Disease
Interventions
- Confirmatory Testing Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 1 Day to 31 Days
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 14, 2018
- Primary completion
- Nov 29, 2025
- Completion
- Dec 30, 2025
- Last update posted
- Apr 3, 2025
2018 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| RTI International | Research Triangle Park | North Carolina | 27709 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03655223, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 3, 2025 · Synced May 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03655223 live on ClinicalTrials.gov.