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Clinical Trials/ACTRN12609000374268
ACTRN12609000374268CompletedPhase 2

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 Service0 sites120 target enrollmentStarted: May 27, 2009Last updated:

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
120

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Prevention
Masking
Blinded (masking used)

Eligibility Criteria

Ages
o limit to 32 Weeks (—)
Sex
All

Inclusion Criteria

  • (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 Criteria

  • (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

Investigators

Sponsor
Womens and Childrens Health Service

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