The safety and efficacy of a locally available probiotic in premature infants.
A randomised placebo controlled pilot trial on the safety and efficacy of a probiotic product in reducing all case mortality and definite necrotizing enterocolitis in preterm very low birthweight neonates.
Womens and Childrens Health Service
120 participants
Dec 7, 2010
Interventional
Conditions
Summary
This is a two stage project: (1) independent microbiological studies to confirm the identity of the probiotic bacteria and the safety (contaminants, unspecified contents, osmolarity) of the probiotic product followed by (2) a pilot clinical trial to test the hypothesis that routine supplementation with this probiotic product will result in colonisation of the gut (primary hypothesis) and reduction in all cause deaths, and diseases like NEC, and late onset sepsis (secondary hypotheses) in premature babies.
Eligibility
Inclusion Criteria4
- (1)Gestation up to 32 weeks and 6 days
- (2)Birth weight under 1500 grams
- (3)Ready to commence or on enteral feeds for up to 12 hours
- (4) Parental Consent
Exclusion Criteria6
- (1) Major congenital malformation
- (2) Chromosomal aberration
- (3) Lack of informed parental consent
- (4) On enteral feeds for more than 12 hours
- (5) Contraindications for enteral feds
- (6) Life threatening illness/condition
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Interventions
This is a prospective double blind placebo controlled randomised trial investigating the safety and efficacy of a locally available probiotic product. Enrolled neonates will be allocated to the product (containing Lactobacillus acidophilus 375 million, Bifidobacterium bifidum & Bifidobacterium longus 125 million organisms) or an identical looking placebo containing maltodextrin. This is available in tablet form, which is crushed and mixed with 3ml of sterile water at the bedside, and given twice daily by mouth / gastric tube, from the start of enteral feeds until discharged home or term (37 weeks post menstral age) whichever comes first.
Locations(1)
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ACTRN12609000374268