Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement

Completed

• Conditions: Neonatal Infection

• Registration Number: NCT01540162
• Lead Sponsor: Odessa National Medical University

Brief 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

Detailed Description

Study design: open-labeled, controlled, parallel group, non-interventional 3-weeks-study with followed prospective observation during 1 week and 1 year follow-up period.

Patients of group I take the probiotic Mutaflor orally in the dose 1 ml once a day during first week of life and three times per week during the second and third week of life. Patients of the group II don't take specific probiotic for immunity strengthening.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-28
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Status Verified: 2015-08
• Results First Submitted: 2015-08-12
• Results First Submitted QC: 2015-08-12
• Last Update Submitted: 2015-08-12
• Results First Posted: 2015-09-10
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Number (Rate) of Patients With Acute Respiratory Infections	first 12 month of life	ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia

Trial Locations

Locations (1)

Maternity House №5; 🇺🇦 Odessa, Ukraine