Baldassarre 2017.
| Study characteristics | ||
| Methods | RCT | |
| Participants | Preterm infants (28 to 33 weeks' gestational age; birth weight 700 to 1750 g and appropriate to gestational age) within 24 hours of first enteral feeding (and whose mother did not plan to exclusively breast feed) | |
| Interventions | Extensively hydrolysed casein infant formula (n = 33) Standard cow's milk‐based preterm infant formula (n = 35) |
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| Outcomes | Enteral intake (mL/kg/d) during first 14 days after birth Feed intolerance measures (abdominal distension, regurgitation/emesis, feedings withheld ≥ 4 hours, or bloody stools) Necrotising enterocolitis Invasive infection |
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| Notes | University of Bari‐Policlinico Hospital, Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, Bari, Italy Trial dates: 2014 to 2016 Trial registration: clinicaltrials.gov/ct2/show/NCT01987154 Further information provided by investigators (August 2017) |
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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 | Sealed opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double‐blind" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Double‐blind" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 60/68 enrolled infants completed trial and contributed to outcome analysis |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Other bias | Unclear risk | Funded by Mead Johnson Nutrition |