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) |
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Interventions | Feed advancement at 15 to 20 mL/kg/d (n = 65) vs 30 to 40 mL/kg/d (n = 66) | |
Outcomes |
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Notes | Published as abstract only Further information available from www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5289 |
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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 |