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

Late onset sepsis in very premature infants (<32 weeks)

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

Plain Language Summary

Simplified for easier understanding

This study tests whether giving probiotics — 'good bacteria' taken by mouth — to very premature babies can reduce the risk of serious infections (called late-onset sepsis). Very premature babies have immature immune systems and are at high risk of infection in hospital. The probiotics are compared to a placebo to see if they can help protect babies from infection and reduce complications. You may be eligible if: - Your baby was born at less than 32 weeks of pregnancy - Your baby weighs less than 1500 grams at birth - Your baby was born at or transferred to a participating hospital within 72 hours of birth - You have given written informed consent You may NOT be eligible if: - Your baby has a known or suspected major birth defect - Your baby is not expected to survive beyond 72 hours Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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) 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