Neonatal Infection
Conditions
Keywords
preterm newborn, neonatology, EcN, Nissle, Mutaflor, prophylaxis, infection
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.
Interventions
None listed
Sponsors
Odessa National Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Hours to 24 Hours
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The Number (Rate) of Patients With Acute Respiratory Infections | first 6 month of life | ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia |
Countries
Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group I 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. | 30 |
| Group II Patients of group II remain unexposed to the probiotic Mutaflor. | 32 |
| Total | 62 |
Baseline characteristics
| Characteristic | Group I | Group II | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 32 Participants | 62 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Ukraine | 30 participants | 32 participants | 62 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 30 | 22 / 32 |
| serious Total, serious adverse events | 11 / 30 | 20 / 32 |
Outcome results
Primary
The Number (Rate) of Patients With Acute Respiratory Infections
ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Time frame: first 28 days of life
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I | The Number (Rate) of Patients With Acute Respiratory Infections | 3 participants |
| Group II | The Number (Rate) of Patients With Acute Respiratory Infections | 14 participants |
p-value: 0.0595% CI: [0.05, 0.73]Chi-squared
Secondary
The Number (Rate) of Patients With Acute Respiratory Infections
ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Time frame: first 6 month of life
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I | The Number (Rate) of Patients With Acute Respiratory Infections | 15 participants |
| Group II | The Number (Rate) of Patients With Acute Respiratory Infections | 23 participants |
Secondary
The Number (Rate) of Patients With Acute Respiratory Infections
ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Time frame: first 12 month of life
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group I | The Number (Rate) of Patients With Acute Respiratory Infections | 23 participants |
| Group II | The Number (Rate) of Patients With Acute Respiratory Infections | 29 participants |