None listed
Conditions
Brief summary
The project is a simple randomised placebo controlled trial of probiotics for very premature infants to determine whether the probiotics reduce late onset infection and associated morbidity and mortality.
Interventions
This is a prospective double-blind placebo-controlled randomised trial investigating the effect of treatment of very low birthweight infants with a probiotic combination (ABC Dophilus Infant Powder) on the primary outcome measure, late onset sepsis. The intervetion ABC Dophilus infant powder contains 1
This is a prospective double-blind placebo-controlled randomised trial investigating the effect of treatment of very low birthweight infants with a probiotic combination (ABC Dophilus Infant Powder) on the primary outcome measure, late onset sepsis. The intervetion ABC Dophilus infant powder contains 1x10^9 of total organisms, consisting of 3 bacterial strains (Bifidobacterium infantis, Bifidobacterium bifidus, Streptococcus thermophilus). This is presented in a powder form in a jar, which is opened, 0.5 teaspoon mixed with 3ml feed and given daily by mouth/nasogastric tube, from the start of milk feeds until dischared home or term (40 weeks post menstral age), whichever comes first.
Sponsors
The Royal Women's Foundation Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
1 Days to 3 Days
Healthy volunteers
No
Inclusion criteria
Infants born/transferred to participating hospital within 72 hrs of birth. * the birthweight of the infant is < 1500 g and < 32 weeks gestation. *Informed written parental consent is obtained.
Exclusion criteria
* The infant has a known or suspected major congenital abnormality* Infants likely to die within 72 hours.
Outcome results
None listed