The safety and efficacy of a locally available probiotic in premature infants.

Phase 2

Completed

• Conditions: ecrotising Enterocolitis; all cause mortality and time to full feeds in preterm very low birthweight neonates; Necrotising Enterocolitis; Reproductive Health and Childbirth - Complications of newborn; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12609000374268
• Lead Sponsor: Womens and Childrens Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified