Methods
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A double‐blinded, placebo‐controlled, randomized trial conducted in India |
Participants
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Inclusion criteria: "Preterm neonates <34 weeks admitted to the NICU" |
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Exclusion criteria: |
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"i. Extramural preterm neonates >10 day age with clinical or lab marker of sepsis |
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ii. Preterm babies with necrotizing enterocolitis (NEC) or an intestinal surgical anomaly |
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iii. Preterm babies with a lethal congenital anomaly, dysmorphism or aneuploidy" |
Interventions
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Intervention: "Bacillus clausii containing 2×109 spores in 5 ml minibottle in a dose of 2 ml per‐oral every 8 h mixed with the enteral feeds through orogastric tube or oral feeds, giving them 2.4×109 spores per day. Probiotic supplementation was continued till postnatal age of 6 weeks, or till discharge or death or occurrence of LOS, whichever was earlier for babies in both" |
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Control: "Babies in the placebo group received sterile water, 2 ml per‐oral every 8 h mixed with feeds" |
Outcomes
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Mortality, sepsis, NEC |
Notes
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Data were taken from table 3 and 4. We combined the numbers for very preterm and extreme preterm babies |