Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement

Neonatal Infection Clinical Trial

— EMSUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540162
• Other study ID #: NIS MU 1128 AO
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: August 12, 2015
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2015
• Source: Odessa National Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: State Pharmacological Center - Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonatal Infection

Locations

Country	Name	City	State
Ukraine	Maternity House ?5	Odessa

Sponsors (1)

Lead Sponsor	Collaborator
Odessa National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No