The probiotic Bifidobacterium breve strain BBG-01 admistered early to preterm infants to prevent infection, necrotising enterocolitis and death. - PIPS: Probiotics In Preterm babies Study
Phase 1
- Conditions
- Necrotising enterocolitis in the preterm baby Late-onset (>72h of age) blood stream infection in the preterm baby Death of preterm babies before discharge from hospital
- Registration Number
- EUCTR2006-003445-17-GB
- Lead Sponsor
- Queen Mary, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1315
Inclusion Criteria
Preterm babies gestation at birth 23w+0d to 30w+6d less than 48h old at recruitment with written informed parental consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•A known lethal congenital abnormality.
•Any known gastrointestinal malformation.
•No realistic prospect of survival.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method