RecruitingPhase 3ACTRN12607000144415

The use of probiotics to reduce the incidence of sepsis in premature infants.

Probiotic effects of ABC Dophilus Infant Powder on incidence, mortality and severity of sepsis in very premature neonates.


Sponsor

The Royal Women's Foundation Ltd

Enrollment

1,100 participants

Start Date

Mar 1, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 3 Dayss

Inclusion Criteria1

  • 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 Criteria1

  • The infant has a known or suspected major congenital abnormality* Infants likely to die within 72 hours.

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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) o

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.


Locations(1)

Australia

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ACTRN12607000144415