N/A
N=62
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
Neonatal Infection
Bottom Line
View on ClinicalTrials.gov: NCT01540162 ↗Enrolled (actual)
62
Serious AEs
50.0%
Results posted
Sep 2015
Primary outcome: Primary: The Number (Rate) of Patients With Acute Respiratory Infections — 3; 14 participants — p=0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Odessa National Medical University
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number (Rate) of Patients With Acute Respiratory Infections |
23; 29 | — |
| SECONDARY The Number (Rate) of Patients With Acute Respiratory Infections |
23; 29 | — |
| SECONDARY The Number (Rate) of Patients With Acute Respiratory Infections |
23; 29 | — |
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
Eligibility Criteria
Inclusion Criteria
- age 12-24 hours of life;
- 1st degree of prematurity (functionally mature infant, gestational age 35-36 weeks);
- exclusive breast feeding during study;
- both parents must sign and date an informed consent for infant's participation in the study.
Exclusion Criteria
- perinatal asphyxia ( Apgar score less than 8);
- significant concomitant disease (congenital birth defects, perinatal encephalopathy, TORCH - infections and other infectious disease of newborn, respiratory distress syndrome ets);
- clinically significant changes in blood analyze results (if needed);
- use of other probiotics or prebiotics during the first 28 days of study participation.
Data sourced from ClinicalTrials.gov (NCT01540162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.