Nandhini 2016.
Study characteristics | ||
Methods | RCT | |
Participants | 220 preterms (28 to 34 weeks) infants (most participants very preterm or VLBW) | |
Interventions | Synbiotics (N = 110): Lactobacillus casei (3 × 10⁸ cfu) + L. rhamnosus (4 x10⁸ cfu) + L. plantaris (3 x10⁸ cfu) + L. bulgaricus (3 x10⁸ cfu) + Bifidobacterium infantis (3 × 10⁸ cfu) + B. breve (3 x10⁸ cfu) + B. longum (4 × 10⁸ cfu) plus FOS (100 mg) added to maternal milk twice daily for 7 days Control (N= 43): no synbiotic supplement |
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Outcomes |
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Notes | India (single centre: study dates not stated) Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unmasked |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unmasked |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete reporting for primary outcomes |
Selective reporting (reporting bias) | Low risk | All outcomes listed in protocol reported |
Other bias | Low risk | No evidence baseline imbalance |