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. 2019 Jul 24;2019(7):CD012412. doi: 10.1002/14651858.CD012412.pub3

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)
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
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)
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