Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement (EMSUP)

Odessa National Medical University

Status: Completed

Conditions: Neonatal Infection

Study type: Observational

Funder types: Other

Identifiers

NCT01540162

NIS MU 1128 AO

Details and patient eligibility

About

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

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 12 to 24 hours old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

62 participants in 2 patient groups

Group I

Description:

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

Description:

Patients of group II remain unexposed to the probiotic Mutaflor.