None listed
Conditions
Brief summary
Premature babies (born before 8 months of pregnancy) are at risk necrotising enterocolitis (NEC), a potentially serious inflammatory condition of the bowel, as well as hospital acquired infections, and poor nutrition. Complications of prematurity such as these, especially NEC, increase the risk of death, and long-term disability. The risk of these complication is high especially in extremely premature babies born before 28 weeks of pregnancy. Probiotics are beneficial bacteria which have been shown to significantly reduce the risk of death, NEC, and hospital acquired infections whilst facilitating nutrition in very premature babies. Probiotic supplementation for very premature babies is a standard practice in all neonatal intensive care units (NICU) in Australia, New Zealand and many units in other countries. We currently administer a daily dose of 3 billion probiotic bacteria for premature babies in our unit using a product imported from Japan, under a special permission from the Australian government. This dose is based on our research using this product and studies of other probiotics. This study is designed to assess if a dose higher than 3 billion bacteria per day is more effective whilst being safe in reducing inflammation, reduce antibiotics resistant organisms in the gut and improving the balance of beneficial versus potentially harmful bacteria in the gut of extremely premature babies. Specifically, the proposed study will compare the dose of 3 billion against 6 and 9 billion bacteria per day in extremely premature babies using the stool (poo) samples. We think that babies who receive higher dose of probiotics will have reduced gut inflammation, more beneficial and less harmful bacteria in the gut and overall health compared to those who receive lower dose.
Interventions
Probiotic mixture containing B. breve M-16V, B. longum subsp. infantis M-63, and B. longum subsp. longum BB536 (Total 3 x 10^9 colony forming unit (cfu) (Guaranteed) in one-gram sachets, Manufactured and supplied by Morinaga Milk Industries, Japan).The single dose (1.5×10^9 cfu/day) will be given via the feeding tube until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×10^9 (given twice a day in divided doses), 6×10^9 (given twice a day in divided doses) or 9 ×10^9 cfu (giv
Probiotic mixture containing B. breve M-16V, B. longum subsp. infantis M-63, and B. longum subsp. longum BB536 (Total 3 x 10^9 colony forming unit (cfu) (Guaranteed) in one-gram sachets, Manufactured and supplied by Morinaga Milk Industries, Japan).The single dose (1.5×10^9 cfu/day) will be given via the feeding tube until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×10^9 (given twice a day in divided doses), 6×10^9 (given twice a day in divided doses) or 9 ×10^9 cfu (given twice a day in divided doses) based on the allocation status of the enrolled infants, once feeds exceed 50 mL/kg/day. Probiotics will be continued until term equivalent age. Contents of one sachet will be diluted with 2mL sterile water to make a final volume of 3mL reconstituted solution. This reconstituted solution should be administered immediately after reconstitution. This can be given orally or via tube at any time with regards to feeds. Probiotics dose is charted in the drug chart for administration
Sponsors
Child and adoloscent health service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 14 Weeks
Healthy volunteers
No
Inclusion criteria
: (1) gestation of <28 weeks, (2) readiness to commence on feeds or on feeds for <12 hours and (3) informed parental consent.
Exclusion criteria
(1) congenital malformations, (2) chromosomal aberrations, (3) not ready for feeds/on feeds for more than equal to 12 hours.
Outcome results
None listed