Effect of single versus multi-strain probiotic supplementation on the time to full enteral feeds in preterm neonates – a double blind randomised controlled trial

Phase 3

Completed

• Conditions: enteral nutrition in preterm neonates; gut colonisation; faecal short chain fatty acids; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Diet and Nutrition - Other diet and nutrition disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12615000940572
• Lead Sponsor: Gayatri Jape

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-08
• Study Completion: 2018-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

(1) Gestation <28 weeks at birth (2) ready to commence on milk feeds or on milk feeds for <12 hours (3) Informed parental consent

Exclusion Criteria

(1) Congenital malformations (2) Chromosomal aberrations (3) Not ready for feeds or on feeds for > 12 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to full enteral feeds (time to achieve 150 ml/kg/day of enteral milk feeds from the day of randomisation) will be the time point for assessment of primary outcome[from commencement of enteral feeds till 37 completed weeks of gestation]

Secondary Outcome Measures

Name	Time	Method
All-cause mortality(clinical notes review within 1 month of mortality)[within 3-4 months of discharge from the hospital];Gut flora and stool colonisation (assayed by conventional stool culture methods)[after completion of enrolment, preferably 3-4 months post discharge from hospital<br>];duration of parenteral nutrition (by review of inbuilt data available in our neonatal database) [during patient stay in hospital or post discharge, within 3-4 months of patient discharge<br>];Necrotizing enterocolitis (NEC)<br>(assayed by clinical record review)[after patient discharge, within 3-4 months following discharge of a patient];Incidence of Late onset sepsis (assayed by blood tests and clinical examination)[after patient discharge, within 3-4 months following pateint discharge];NEC related mortality (by review of medical records)[after patient death, within 1 month upto a maximum of 4 months post discharge]