At a glance
ClinicalIndex Comparison RecordN/ACompleted· 62 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study for Neonatal Infection. Completed, enrolled 62 participants across 1 site.
Detailed Summary
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
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Infection
CountriesUkraine
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedFeb 2012
Primary CompletionJul 2012
Study CompletionDec 2012
TodayJul 2026
First PostedFeb 28, 2012
Enrollment StartMar 1, 2011
Primary CompletionJul 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago