Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Neonatal Infection

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Hours
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life. | |
| Group II<br>Patients of group II remain unexposed to the probiotic Mutaflor. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number (Rate) of Patients With Acute Respiratory Infections | ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia | first 28 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number (Rate) of Patients With Acute Respiratory Infections | ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia | first 6 month of life | 
| The Number (Rate) of Patients With Acute Respiratory Infections | ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia | first 12 month of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EcN, preterm newborn, neonatology, Nissle, Mutaflor, prophylaxis, infection