Publication: Placebo Controlled Introduction of Prophylactic Supplementation of Probiotics to Decrease the Incidence of Necrotizing Enterocolitis at Dhulikhel Hospital in Nepal
Date
2017
Journal Title
Journal ISSN
Volume Title
Publisher
Kathmandu University
Abstract
ABSTRACT
Background
Although recent reports suggest that the use of probiotics may enhance intestinal
functions in premature infants, the mechanisms are unclear, and open questions
remain regarding the safety and its efficacy.
Objective
The objective of this study is to evaluate the efficacy of probiotics on prevention of
necrotizing enterocolitis in preterm infants in Nepal.
Method
We conducted a randomized, double blind, placebo controlled study of 72
hospitalized preterm infants. They were randomly allocated to receive probiotics
(lactobacillus rhamnosus 35) at a dose of 0.8 mg in infants >1500 gms and 0.4 mg
in infants <1500 gms in 2 ml of expressed breast milk two times daily or the same
amount of expressed breast milk as placebo (without probiotics).
Result
Seventy-two patients were studied. The probiotics group (n=37) and placebo
group (n=35) showed similar clinical characteristics. The incidence of necrotizing
enterocolitis was found less frequently in the probiotic group (6/37, 16.2%) compared
to the control group (10/35, 28.6%), this difference was not significant (p=0.16). This is
12.35% reduction in the incidence of necrotizing enterocolitis. Among the risk factors
for necrotizing enterocolitis, pregnancy risk factors and perinatal risk factors were
not significant. However neonatal risk factors were more frequent in the probiotic
group (59.3%, n=32) than in the placebo group (40.7%, n=22), the difference was
significant (p=0.02).
Conclusion
In the western world probiotics have been shown to be preventive in regard to
necrotizing enterocolitis incidence. The present randomized trial showed a trend
towards necrotizing enterocolitis minimal reduction in Nepal too. Further studies in
a larger cohort are warranted to prove this effect for preterm infants.
KEY WORDS
Necrotizing enterocolitis, Placebo, Probiotics
Description
Dongol Singh S,1 Klobassa DS,2 Resch B,3 Urlesberger B,3 Shrestha RPB1
1Department of Paediatrics
Kathmandu University School of Medical Sciences
Dhulikhel, Kavre, Nepal.
2Department of Pediatric
3Division of Neonatology,
Medical University Graz,
8036 Graz, Austria
Keywords
Necrotizing enterocolitis, Placebo, Probiotics