Who is sponsoring NCT02943304?

NCT02943304 is sponsored by Universidad Industrial de Santander.

What condition does NCT02943304 study?

NCT02943304 studies Microcephaly, Mental Retardation.

Is NCT02943304 still recruiting?

NCT02943304 is currently completed. Last updated 9 January 2023.

Last reviewed 2023-01-09 · How we verify

NCT02943304: ZENI

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

Neurodevelopment Outcome of Newborns Exposed to Zika Virus (ZIKV) in Utero

Completed Last updated 9 January 2023

What this trial tests

trial testing Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV in Microcephaly in 284 participants. Completed in 20 December 2022.

Timeline

1 May 2016

Primary endpoint
15 December 2020

20 December 2022

Quick facts

Lead sponsor	Universidad Industrial de Santander
Status	Completed
Study type	OBSERVATIONAL
Enrollment	284
Start date	1 May 2016
Primary completion	15 December 2020
Estimated completion	20 December 2022
Sites	1 location across Colombia

Drugs / interventions tested

Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV

Conditions studied

Microcephaly — all drugs for Microcephaly →
Mental Retardation — all drugs for Mental Retardation →

Sponsor

Universidad Industrial de Santander

Who can join

Adults 13 to 50, female only, with Microcephaly or Mental Retardation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective cohort study will determine the natural history of fetal exposure to Zika virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according to trimester of infection and as exposed and unexposed to ZIKV.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Fetal central nervous system anomalies according to RT-PCR and trimester of maternal infection with Zika virus: A prospective cohort study.
Gutiérrez-Sánchez LÁ, Becerra-Mojica CH, Rojas MA, Díaz-Martínez LA, et al · · 2022 · cited 7× · PMID 34904224 · DOI 10.1111/aogs.14301
Neurodevelopmental outcome of infants without central nervous system anomalies born to symptomatic RT-PCR ZIKV positive women.
Díaz-Martínez LA, Rojas MA, Pinilla-García LS, Becerra-Mojica CH, et al · · 2022 · cited 3× · PMID 35255097 · DOI 10.1371/journal.pntd.0009854

Verify or expand the search:

Other recruiting trials for Microcephaly

Currently open trials in the same condition.

NCT06019182 — MEHMO Natural History and Biomarkers · recruiting
NCT05518188 — Melpida: Recombinant Adeno-associated Virus (serotype 9) Encoding a Codon Optimized Human AP4M1 Transgene (hAP4M1opt) · Phase 1, PHASE2 · recruiting
NCT03325946 — The FBRI VTC Neuromotor Research Clinic · recruiting

Other Universidad Industrial de Santander trials

Trials by the same sponsor.

NCT07149753 — Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis · Phase 1 · not yet recruiting
NCT06614517 — Bird Watching to Reduce Stress in University Students · NA · completed
NCT03675958 — Immediate Effect of Johnstone's Pressure Splint Added to Stretching on the Spasticity in Cerebrovascular Disease. · NA · unknown
NCT03423914 — Efficacy of Expressive Writing in Mothers of Preterm Infants · NA · unknown
NCT03070158 — Affective Bonding in Mothers and Their Premature Newborn · NA · unknown

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 NCT02943304 (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 Universidad Industrial de Santander
Last refreshed: 9 January 2023

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/NCT02943304.

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