O'Connor 2018.
Methods | Randomized clinical trial | |
Participants | 127 infants < 1250 g Exclusion criteria: Receipt of formula or bovine milk‐based fortifier prior to randomization and if enteral feeding not commenced within 14 days after birth. Congenital or chromosomal anomaly affecting growth. Setting: 2 tertiary NICUs, Sinai Health System and The Hospital for Sick Children, Toronto, Canada. |
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Interventions | Intervention: (N = 64) Mother's own milk or pasteurized donor human milk fortified with human milk‐based fortifier (HMBF) (Prolact+, Prolacta Bioscience) to achieve 0.81 kcal/mL (24 kcal/oz), and 0.88 kcal/mL (26 kcal/oz), Control: (N = 63) Mother's own milk or pasteurized donor human milk fortified with bovine milk‐based fortifier (BMBF) (Similac Human Milk Fortifier Powder, Abbott Nutrition) to 0.72 kcal/mL (22 kcal/oz) and 0.78 kcal/mL (24 kcal/oz), and with the addition of powdered formula (Similac Neosure, Abbott Nutrition) to further concentrate feeds to 0.88 kcal/mL (26 kcal/oz). | |
Outcomes |
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Notes | Fortification of breast milk in both groups commenced at feed volumes of ≥ 100 mL/kg/d. In the HMBF group, fortification began at 0.81 kcal/mL (24 kcal/oz), and increased to 0.88 kcal/mL (26 kcal/oz) when volume reached 140 mL/kg/d. In the BMBF group, fortification began at 0.72 kcal/mL (22 kcal/oz) and increased to 0.78 kcal/mL (24 kcal/oz) when volumes reached 140 mL/kg/d. In the BMBF group, intact‐protein modular (Beneprotein, Nestle) was added to donor milk after fortification had reached up to 0.78 kcal/mL) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomization of 4 |
Allocation concealment (selection bias) | Low risk | Allocation by an online third party service |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Triple‐blind study. Feeding assignments were masked using amber colored tubing and color wrapping for bottles. |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | Low risk | Triple‐blind study. The reporting team was blinded to the intervention. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Triple blind‐study. The reporting team was blinded to the intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two infants (2/63) in the control group were excluded since they died before intervention. |
Selective reporting (reporting bias) | Low risk | All outcomes planned were reported. |
Other bias | Low risk | None noted |
BMBF: Bovine milk‐derived fortifier HMBF: Human milk‐derived fortifier NEC: Necrotizing enterocolitis NICU: Neonatal intensive care unit