NCT01540162 (EMSUP) is a clinical trial in Neonatal Infection, sponsored by Odessa National Medical University.

Who is sponsoring NCT01540162?

NCT01540162 is sponsored by Odessa National Medical University.

What condition does NCT01540162 study?

NCT01540162 studies Neonatal Infection.

Is NCT01540162 still recruiting?

NCT01540162 is currently completed. Last updated 12 August 2015.

Are results published for NCT01540162?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-08-12 · How we verify

NCT01540162: EMSUP

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

Open-labelled, Controlled, Parallel Group Study to Assess the Efficacy and Safety of MUTAFLOR in 3 Weeks Treatment for Immunity Improvement in Preterm Infants With 1 Year Follow-up Period

Completed Results posted Last updated 12 August 2015

What this trial tests

trial in Neonatal Infection in 62 participants. Completed in 1 December 2012.

Timeline

1 March 2011

Primary endpoint
1 July 2012

1 December 2012

Quick facts

Lead sponsor	Odessa National Medical University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	62
Start date	1 March 2011
Primary completion	1 July 2012
Estimated completion	1 December 2012
Sites	1 location across Ukraine

Conditions studied

Neonatal Infection — all drugs for Neonatal Infection →

Sponsor

Odessa National Medical University

Who can join

Adults 12 Hours to 24 Hours, any sex, with Neonatal Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The Number (Rate) of Patients With Acute Respiratory Infections
Time frame: first 28 days of life
ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia

Sponsor's own description

EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in children, prophylactics of pathological colonization in newborns including premature newborns, and improvement of immunity in newborns (mature and premature). The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for immunity improvement in preterm newborn infants

Publications & conference data

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

Prophylaxis of acute respiratory infections via improving the immune system in late preterm newborns with <i>E</i>. <i>coli</i> strain Nissle 1917: a controlled pilot trial.
Aryayev ML, Senkivska LI, Bredeleva NK, Talashova IV. · · 2018 · cited 8× · PMID 29713493 · DOI 10.1186/s40814-018-0271-y

Verify or expand the search:

Other recruiting trials for Neonatal Infection

Currently open trials in the same condition.

NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting
NCT06656104 — Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections · recruiting
NCT06102044 — Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania · Phase 3 · recruiting
NCT06283355 — Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome · Phase 1 · recruiting
NCT05695196 — Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant · Phase 1 · active not 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 NCT01540162 (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 Odessa National Medical University
Last refreshed: 12 August 2015

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/NCT01540162.

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