Prophylaxis with lactoferrin and lactobacillusGG in Very Low Birth Weight (VLBW) neonates in Neonatal Intensive Care Unit (NICU): a double-blind, multicentre, placebo-controlled, randomised trial

Not Applicable

Completed

• Conditions: Bacterial and fungal colonization and infection, and Necrotising EnteroColitis (NEC) in Very Low Birth Weight (VLBW) neonates; Neonatal Diseases

• Registration Number: ISRCTN53107700
• Lead Sponsor: Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy)

Brief Summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19809023 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22184648 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24709463 2018 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/29198543

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-06
• Study Completion: 2008-07-31
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

All neonates with birth weight <1500 g (i.e. VLBW) born within the study period, whether at one of the eighteen participating institutions or elsewhere, were eligible for the study.

Exclusion Criteria

1. Parental refusal
2. Admission after 12 hours of life
3. Death prior to 72 hours of life
4. Ongoing systemic antifungal management
5. Ongoing antifungal prophylaxis

Study & Design

• Study Type: Interventional
• Study Design: Not specified