| Methods |
Randomised controlled trial |
| Participants |
70 infants (< 33 weeks') with insufficient maternal breast milk during the first 14 days after birth. One neonatal unit in Italy, 2015 |
| Interventions |
Preterm formula (N = 35) versus donor breast milk (N = 35) given as a supplement to maternal breast milk |
| Outcomes |
Time to full enteral feeding (150 mL/kg/day), invasive infection, NEC, bronchopulmonary dysplasia (BPD), or mortality until 36 weeks' post‐menstrual age |
| Notes |
Fortification policy not described (author contacted June 2019 for clarification: simonetta.costa@policlinicogemelli.it) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Computer‐generated list of random numbers" |
| Allocation concealment (selection bias) |
Low risk |
"...sequence was concealed from researchers" |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Families and clinicians not masked |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Complete assessment for primary outcome |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| Other bias |
Unclear risk |
Funder not stated |
