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Parameter Probiotics for Promoting Feed Lactobacillus reuteri DSM 17938

Tolerance in Very Low Birth Improves Feeding Intolerance in


Weight Neonates — A Preterm Infants
Randomized Controlled Trial

Desain Double blinded randomized control trial double-blind randomized controlled


trial
Periode August 2012 to November 2013 January to October 2017
Lokasi A tertiary neonatal intensive care unit (NICU) the Neonatology Unit, Department of
in Southern India Pediatric Health of the Dr. Cipto
Mangunkusumo Hospital
Tujuan to determine the efficacy of probiotics on to evaluate the effect of L. reuteri
feed tolerance in very low birthweight DSM 17938 on feeding intolerance in
(VLBW) neonates preterm infants
Kriteria Inklusi All neonates with a birth weight between 750 neonates with a gestational age of
g to 1499 g admitted to the NICU in whom 28–34 weeks and a birth weight of
enteral feeds 1,000–1,800 g in a stable condition
allowing the administration of oral and
enteral nutrition and was conducted at
the Neonatology Unit
Partisipan 104 newborns with a birth weight of 750 - 94 neonates with a gestational age of
1499 g on enteral feeds 28–34 weeks and birth weight of
1,000–1,800 g
Intevensi Probiotic group received a multicomponent The probiotic intervention in this study
probiotic formulation of Lactobacillus was L. reuteri DSM 17938 (Interlac)
acidophilus, Lactobacillus rhamnosus, suspension
Bifidobacterium longum and Saccharomyces
boulardii once a day at a dose of 1.25×109
CFU from the time of initiation of enteral
feeds till discharge and the control group
received only breast milk
Luaran (Outcome) Primary outcome : Time to reach full Primary outcome : Feeding intolerance
enteral feeds (150 mL/kg/day) Secondary outcome : differences
Secondary outcome : episodes of feed between probiotics and placebo in
intolerance, incidence of NEC stage 2 or duration of total parenteral nutrition
more, duration of hospital stay, days on total (TPN), number of days needed to
parenteral nutrition (TPN), weight gain and reach full enteral feeding, length of
mortality during hospital stay stay, sepsis, diarrhea, and NEC
incidence and severity
Bias Cross-contamination in the control arm is -
expected to underestimate the true effects of
probiotics

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