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. 2022 Mar 1;2022(3):CD014067. doi: 10.1002/14651858.CD014067.pub2

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
Outcomes
  • NEC 

  • Death

  • Invasive infection

  • Length of hospital stay

Notes India (single centre: study dates not stated)
Funding: not stated
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