A double-blind randomised controlled trial of the heat-inactivated Pediococcus acidilactici K15 in preterm infant to prevent viral respiratory tract infection after NICU discharge.
Not Applicable
- Conditions
- Prevention of viral respiratory tract infection
- Registration Number
- JPRN-UMIN000033758
- Lead Sponsor
- Chiba University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with a precious allergy to Lactic acid bacteria or soy beans. 2)Patients with congenital heart disease, severe respiratory disease, chromosomal abnormality, and primary immunodeficiency disease. 3)Patients who were determined as unsuitable subjects by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of febrile days during the exam period
- Secondary Outcome Measures
Name Time Method The incidence of respiratory infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during respiratory infection. The incidence of respiratory syncytial virus (RSV) infection which were diagnosed by physician. The severity of respiratory disturbance measured by necessities of hospitalization, oxygenation, and mechanical ventilation during RSV infection. Serum IgG,IgA and IgM levels before and after intervention. The adverse events associated with K15.