Fortification of breast milk with preterm formula powder noninferior compared to human milk fortifier in preterm neonates

1. Among a group of very low birth weight (VLBW) neonates, fortification with preterm formula was not found to be inferior to fortification with human milk fortifiers.

Evidence Rating Level: 1 (Excellent)

Fortification of expressed breast milk (EBM) with human milk fortifiers (HMF) has been shown to lead to increased weight and length in VLBW neonates. However, its use is limited due to high cost and risk of feed intolerance. In this parallel group, non-inferiority randomized trial, researchers sought to investigate whether or not fortification with preterm formula (PTF) would be noninferior to HMF and provide a potentially cheaper alternative for fortification. The primary outcome measured to assess this was the rate of in-hospital weight gain. The secondary outcomes measured were mortality, rate of increase in head circumference and length at discharge, feed intolerance, necrotizing enterocolitis, intraventricular hemorrhage (IVH), metabolic bone disease (MBD), anemia requiring transfusion, late metabolic acidosis (LMA), bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP). The study randomized 123 neonates, born at 34 weeks or less, into a control group which received HMF (n = 63) and an intervention group which received PTF (n = 60). Baseline characteristics of the neonates such as birth weight and gestation were comparable between the two groups. The mean (SD) weight gain in neonates receiving PTF was 15.7 (3.9) g/kg/day while neonates receiving HMF gained 16.3 (4) g/kg/day (mean difference = -0.5g/kg/day, 95% CI: -1.9 to 0.7). This did not cross a pre-specified inferiority margin of 2g/kg/day. Similarly, the gain in length and head circumference was comparable in both groups. The incidence of feed intolerance was lower in the PTF group (incidence rate ratio [IRR] = 0.29, 95% CI: 0.04 to 0.95). The proportion of patients in whom fortification had to be withheld for 24 or more hours was lower in the PTF group (5% vs 22%, risk ratio = 0.22, 95% CI: 0.07 – 0.75). There were no significant differences between the groups in terms of incidence of NEC, mortality, sepsis, MBD, IVH, PDA, ROP or BPD. Thus, the study concluded that PTF is non-inferior to HMF when used in VLBW neonates. With further validation, this may provide a more cost-friendly alternative to HMF for EBM fortification, especially for areas and individuals who may have limited financial resources.

Click to read the study on JAMA Pediatrics

Image: PD

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