The administration of probiotic to premature babies to prevent infection, severe intestinal complication (i.e. necrotising enterocolitis) and death

Completed

• Conditions: Blood stream infection and necrotising enterocolitis in preterm infants; Neonatal Diseases

• Registration Number: ISRCTN05511098
• Lead Sponsor: Queen Mary, University of London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-24
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

1. Both males and females, born before 31 completed weeks of gestation, i.e. up to and including 30 weeks + 6 days by the best estimate of Expected Date of Delivery (usually by first trimester antenatal ultrasound, alternatively calculated from the first day of the last menstrual period [LMP])
2. Less than 48 hours old
3. With written informed parental consent
4. Babies already on antibiotics for suspected or proven infection are eligible for recruitment to the study

Exclusion Criteria

1. A lethal congenital abnormality known at trial entry
2. Any known gastrointestinal malformation
3. No realistic prospect of survival

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Any baby with an episode of blood stream infection, with any organism other than a skin commensal, diagnosed on a sample of blood drawn more than 72 hours after birth and before death or discharge from hospital. Skin commensals include coagulase negative staphylococci (CoNS) and Corynebacteria. <br>2. Necrotising enterocolitis, Bell stage II or III. Duration of follow-up: until discharge from hospital or death.<br>3. Death before discharge from hospital