The use of probiotics to reduce the incidence of sepsis in premature infants.

Phase 3

Recruiting

• Conditions: ate onset sepsis in very premature infants (<32 weeks); Late onset sepsis in very premature infants (<32 weeks); Blood - Other blood disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12607000144415
• Lead Sponsor: The Royal Women's Foundation Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Infants born/transferred to participating hospital within 72 hrs of birth. * the birthweight of the infant is < 1500 g and < 32 weeks gestation. *Informed written parental consent is obtained.

Exclusion Criteria

* The infant has a known or suspected major congenital abnormality* Infants likely to die within 72 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of proven or probable late onset sepsis (>48 hrs after birth)[Before expected due date (EDD).];The frequency events [Continuous surveillance];Cummulative frequency[Compared at 4 weeks of age and at EDD.]

Secondary Outcome Measures

Name	Time	Method
The incidence of necrotising enterocolitis (NEC), death, length of the primary hospital admission including proportion experiencing prolonged hospital stay, number of courses of antibiotics, number of days until full oral feeds established (120 ml/kg). [These will be measured at EDD.];Weight, length and head cirucmference[Measured at the 6 and 12 months corrected age, and hospital admissions during the first year will be measured at 12 months corrected age.];Blood (1-2 ml) to measure immunoglobulins, number of Tregs, and IL-10 and transforming growth factor-beta (TGF-beta).[Will be taken at 6 and 12 months];A maternal questionnaire will be used to report atopic eczema, but will also note food allergies, and wheeze from term until 12 months corrected age.[At 12 months]