NCT04012190 is a clinical trial in Severe Infection and Non-injury Death, sponsored by The Hospital for Sick Children.

Who is sponsoring NCT04012190?

NCT04012190 is sponsored by The Hospital for Sick Children.

What condition does NCT04012190 study?

NCT04012190 studies Severe Infection and Non-injury Death.

Is NCT04012190 still recruiting?

NCT04012190 is currently completed. Last updated 31 October 2022.

Last reviewed 2022-10-31 · How we verify

NCT04012190

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

SEPSIS Observational Cohort Study in Young Infants in Bangladesh

Completed Last updated 31 October 2022

What this trial tests

trial in Severe Infection and Non-injury Death in 2,083 participants. Completed in 22 October 2022.

Timeline

12 February 2020

Primary endpoint
22 October 2022

22 October 2022

Quick facts

Lead sponsor	The Hospital for Sick Children
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,083
Start date	12 February 2020
Primary completion	22 October 2022
Estimated completion	22 October 2022
Sites	2 locations across Bangladesh

Conditions studied

Severe Infection and Non-injury Death — all drugs for Severe Infection and Non-injury Death →

Sponsor

The Hospital for Sick Children

Who can join

Adults 0 Days to 49, any sex, with Severe Infection and Non-injury Death. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Globally, infectious diseases such as sepsis, meningitis and pneumonia are among the leading causes of neonatal deaths. A recent observational study in South Asia highlighted the contribution of both bacterial and viral infections to the burden of illness in infants \<60 days of age; however, there remains a need to quantify the risk of severe infection (SI) among newborns in a Bangladeshi population. In collaboration with researchers in Bangladesh, investigators aim to generate knowledge regarding the incidence and risk factors of SI, including the composition of the intestinal microbiome, in young infants (birth to 60 days of age) in Dhaka, Bangladesh. Data will support the design and implementation of future trials to test the efficacy of novel interventions for the prevention of SI in young infants, to promote optimal growth and development, and to determine effects on other health outcomes in early infancy.

Publications & conference data

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

Neonatal administration of Lactiplantibacillus plantarum ATCC 202195 with or without fructooligosaccharide in Bangladesh: a placebo-controlled randomized trial.
Pell LG, Qamar H, Bassani DG, Heasley C, et al · · 2025 · cited 5× · PMID 39992135 · DOI 10.1128/msphere.01032-24
Abundance of Bifidobacterium species in the infant gut microbiota and associations with maternal-infant characteristics in Dhaka, Bangladesh.
Freitas AC, Li G, Shawon J, Qamar H, et al · · 2025 · cited 3× · PMID 40951971 · DOI 10.1128/msphere.00314-25
Detection and absolute quantification of Lactiplantibacillus plantarum ATCC 202195 by quantitative real-time PCR.
Shawon J, Pell LG, Kabir M, Evans K, et al · · 2024 · cited 3× · PMID 38018977 · DOI 10.1128/spectrum.02711-23
Severe infection incidence among young infants in Dhaka, Bangladesh: an observational cohort study.
Fung A, Heasley C, Pell LG, Bassani DG, et al · · 2025 · cited 1× · PMID 40661255 · DOI 10.1136/bmjph-2024-002383

Verify or expand the search:

Other The Hospital for Sick Children trials

Trials by the same sponsor.

NCT07454681 — MRI Assessment of Lung Airways in Cystic Fibrosis: Evaluate MRI's Ability to Detect Changes in Airway Structure . · not yet recruiting
NCT07452575 — 3D Ultrasound in Hemophilic Ankles · NA · not yet recruiting
NCT07508826 — AI-assisted Endotracheal Intubation · NA · not yet recruiting
NCT07345819 — Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis · NA · not yet recruiting
NCT07497178 — MRgFUS for Childhood Epilepsy · NA · not yet 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 NCT04012190 (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 The Hospital for Sick Children
Last refreshed: 31 October 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/NCT04012190.

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