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. 2021 Aug 24;2021(8):CD001241. doi: 10.1002/14651858.CD001241.pub8

Modi 2015.

Study characteristics
Methods Randomised controlled trial
Participants Newborn infants with birth weight of 750 to 1250 grams who commenced enteral feeds within 4 days after birth. Mean gestational age of participants was 31 weeks.
Exclusion criteria were (quote: "gross congenital malformation and anomalies of gastrointestinal tract").
Setting: Department of Neonatology, Maulana Azad Medical College, New Delhi, India (2012 to 2014)
Interventions Feed advancement at 15 to 20 mL/kg/d (n = 65) vs 30 to 40 mL/kg/d (n = 66)
Outcomes
  • NEC

  • Incidence of feed intolerance

  • Invasive infection

  • In‐hospital (all‐cause) mortality

  • Mean daily weight gain

  • Time to achieve full enteral feeds

Notes Published as abstract only
Further information available from www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5289
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stratified block randomisation (computer‐generated)
Allocation concealment (selection bias) Low risk Sequentially numbered, sealed, opaque 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 No loss to follow‐up
Selective reporting (reporting bias) Low risk Unlikely
Other bias Low risk No evidence of baseline imbalance