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

Category Primary study
Registry of TrialsANZCTR
Year 2007
INTERVENTION: 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. CONDITION: Late onset sepsis in very premature infants (<32 weeks) PRIMARY OUTCOME: Cummulative frequency The frequency events The incidence of proven or probable late onset sepsis (>48 hrs after birth) SECONDARY OUTCOME: A maternal questionnaire will be used to report atopic eczema, but will also note food allergies, and wheeze from term until 12 months corrected age. Blood (1‐2 ml) to measure immunoglobulins, number of Tregs, and IL‐10 and transforming growth factor‐beta (TGF‐beta). The incidence of necrotising enterocolitis (NEC), death, length of the primary hospital admission including proportion experiencing prolonged hospital stay, number of courses of antibiotics, number of days until full oral feeds established (120 ml/kg). Weight, length and head cirucmference 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.
Epistemonikos ID: ce7da86db0a312c7e3d3c3c829959750d8886548
First added on: Aug 25, 2024