Underwood 2009.
Study characteristics | ||
Methods | RCT | |
Participants | 90 preterm (< 35 weeks) or low birth weight (750 to 2000 g) infants (most participants very preterm or VLBW) | |
Interventions | [3‐arm trial] Synbiotics (N = 61): (i) Lactobacillus rhamnosus (5 × 10⁸ cfu) OR (ii) L. acidophilus (1 × 1010 cfu) + Bifidobacterium longum (5 × 10⁸ cfu) + B. bifidum (cfu) +B. infantis (5 × 10⁸ cfu) plus inulin (dose not stated) given twice daily dissolved in saline for 28 days or until hospital discharge Control (N = 29): placebo (1:30 dilute preparation of elemental formula) Participating infants were fed with human milk or formula (or both). |
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Outcomes |
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Notes | USA (single centre: 2004‐ 06) Funding: NIH UC Davis K30 Program (#UL1RR024146, MAU) and the Children's Miracle network (CLB). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Pharmacy‐assigned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Masked (placebo‐controlled) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Masked (placebo‐controlled) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete reporting |
Selective reporting (reporting bias) | Low risk | Unlikely |
Other bias | Low risk | No evidence baseline imbalance |
cfu: colony‐forming units;FOS: fructo‐oligosaccharides;GOS: galacto‐oligosaccharides; NEC: necrotising enterocolitis; NIH:National Institutes of Health; RCT: randomized controlled trial; VLBW: very low birth weight