NCT03087357 (VALUE) is a clinical trial of SmartNIPT in Down Syndrome, sponsored by Women and Infants Hospital of Rhode Island.

Who is sponsoring NCT03087357?

NCT03087357 is sponsored by Women and Infants Hospital of Rhode Island.

What drugs are being tested in NCT03087357?

Interventions in NCT03087357: SmartNIPT.

What condition does NCT03087357 study?

NCT03087357 studies Down Syndrome, Trisomy 18, Trisomy 13.

Is NCT03087357 still recruiting?

NCT03087357 is currently completed. Last updated 22 September 2022.

Last reviewed 2022-09-22 · How we verify

NCT03087357: VALUE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

VAlidation of a Lower Cost aneUploidy scrEen

Completed Last updated 22 September 2022

What this trial tests

trial testing SmartNIPT in Down Syndrome in 2,443 participants. Completed in 1 October 2020.

Timeline

10 October 2017

Primary endpoint
19 November 2019

1 October 2020

Quick facts

Lead sponsor	Women and Infants Hospital of Rhode Island
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,443
Start date	10 October 2017
Primary completion	19 November 2019
Estimated completion	1 October 2020
Sites	16 locations across Italy, Canada, United States

Drugs / interventions tested

SmartNIPT

Conditions studied

Down Syndrome — all drugs for Down Syndrome →
Trisomy 18 — all drugs for Trisomy 18 →
Trisomy 13 — all drugs for Trisomy 13 →

Sponsor

Women and Infants Hospital of Rhode Island

Who can join

18 and older, female only, with Down Syndrome or Trisomy 18. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will document the detection rate and false positive rate as well as failure rate of a new prenatal screening approach ('Smart NIPT') as described at www.vanadisdx.com and implemented in an academic laboratory with limited molecular testing experience. Testing will be performed on samples from a general risk pregnancy population, with additional high-risk cases added to improve confidence in the detection rate. Additional characteristics of this non-NGS test such as turn-around time, costs (equipment, training, per test), results reporting, fetal sex, fetal fraction, and quality measures will also be examined.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Assessment of a Simplified Cell-Free DNA Method for Prenatal Down Syndrome Screening.
Palomaki GE, Eklund EE, Kloza EM, Lambert-Messerlian GM. · · 2022 · cited 5× · PMID 36103259 · DOI 10.1093/clinchem/hvac131

Verify or expand the search:

Other recruiting trials for Down Syndrome

Currently open trials in the same condition.

NCT07416201 — Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy · recruiting
NCT07484464 — Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome · NA · recruiting
NCT07428863 — Effects of Jump Rope on Navicular Drop in Down Syndrome · NA · recruiting
NCT07260136 — Cervical Spine Abnormalities in Down Syndrome · active not recruiting
NCT07248449 — Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises · NA · recruiting

Other Women and Infants Hospital of Rhode Island trials

Trials by the same sponsor.

NCT06930508 — Bringing Medicines for HIV Prevention to a Family Planning Clinic · NA · not yet recruiting
NCT07437131 — Community-Partnered Doula Support for Neonatal Intensive Care Unit Families · NA · recruiting
NCT07077707 — Prenatal Genetics Chatbot Trial: Prenatal GENEie · NA · not yet recruiting
NCT07222852 — Cardiovascular Protection After Preeclampsia With Enalapril · Phase 3 · not yet recruiting
NCT05861531 — Combined Oral Motor Stimulation and Language on Preterm Infant Feeding · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03087357 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island
Last refreshed: 22 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03087357.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing