Preterm formula powder fortifiers noninferior to human milk fortifiers
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In terms of short-term weight gain, preterm formula powder fortifiers were noninferior to human milk fortifiers in a study of around 120 preterm very-low-birth-weight neonates in India, researchers reported in JAMA Pediatrics showed.
“Fortification of expressed breast milk using commercially available human milk fortifiers (HMF) increases short-term weight and length in preterm very low-birth-weight neonates. However, the high cost and increased risk of feed intolerance limit their widespread use,” Arunambika Chinnappan, MD, and colleagues from the division of neonatology at the All India Institute of Medical Sciences in New Delhi, and colleagues wrote. “Preterm formula powder fortification (PTF) might be a better alternative in resource-limited settings.”
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Chinnappan and colleagues conducted an open-label, noninferiority, randomized trial from December 2017 through June 2019 that included 123 preterm neonates with a birth weight less than 1500 g who were born at or before 34 weeks’ gestation. They randomly assigned them to receive either PTF (n = 60) or commercially available human milk HMFs (n = 63).
Among those receiving PTF, 1 g of formula powder was added for every 25 mL of expressed breast milk. Sachets of specified quantities of PTF were made by a pharmacy for the trial. For those receiving HMF, one sachet was added to 25 mL per the manufacturer’s recommendation.
Outcome data were available for 122 neonates. The mean weight gain from the time fortification was introduced until hospital discharge was 15.7 g/kg per day in the PTF group, and 16.3 g/kg per day in the HMF group for a mean difference between the two groups of –0.5 g/kg per day (95% CI, –1.9 to 0.7), the researchers reported.
The length of the infant and size of the infants’ head circumference were comparable in both groups as well. Those in the PTF group had a mean length growth of 0.83, whereas those in the HMF group had a mean length growth of 0.69, a mean difference of –0.03 (95% CI, –0.07 to 0.09). The mean gain in head circumference was 0.64 in the PTF group and 0.69 in the HMF group for a mean difference of –0.05 (95% CI, –0.07 to 0.09).
According to the researchers, a “remarkably high” proportion of neonates had postnatal growth restrictions at 40 weeks of postmenstrual age. Of those in the PTF group, 73% of infants had developed extrauterine growth restriction (EUGR) compared with 81% of infants in the HMF group.
“One of the key reasons for the conduct of the study was the high cost of fortification associated with the commercially available HMFs, which could limit its use in most [low- and middle-income countries] settings,” the authors wrote. “Given that fortification with preterm formula is less expensive, it seems to be a better option for fortifying breast milk, particularly in neonates from resource-constrained settings.”
In a related editorial, Mercedes Pilkington, MD, a pediatric general surgery resident at the University of Calgary, and colleagues said physicians should take caution before promoting universal fortification from PTF.
“The study had only short-term follow-up and, despite exceeding recommended daily energy intake, failed to establish adequate growth velocity to prevent EUGR,” Pilkington and colleagues wrote. “The worrisome rate of EUGR reported in this population is striking.”
Pilkington and colleagues said that dealing with intrauterine growth restriction and EUGR requires attention to the mother-child dyad and not solely the neonate. They said advocacy for affordable breast milk supplementation, and other cost-effective interventions that decrease preventable preterm death, is needed.
References:
Chinnappan A, et al. JAMA Pediatr. 2021;doi:10.1001/jamapediatrics.2021.0678.
Pilkington M, et al. JAMA Pediatr. 2021;doi:10.1001/jamapediatrics.2021.0689.
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It's definitely a small study. It's interesting looking at different ways of fortifying breast milk. It is somewhat specific to India because, comparatively, in the United States, we have liquid fortifiers to add to human milk around the same time period that don't change the osmolality.
That was one thing the authors were discussing as a concern with using the HMF that they have available to them, and the cost could also be something different, based on locality, as well. I only mention that because that was one of [the authors’] bigger points — there was the high cost for them to use the HMF compared with just adding powdered formula to create extra calories and the minerals to help with growth.
It's an interesting observation, locally for them, that the preterm formula supplementation yielded very similar growth, but the limitations are that there's definitely a lot of different ways someone can fortify feeds, and if they're worried about adverse effects from the HMF, you could spread out what you're fortifying with so you don't make it as hyperosmolar.
It's hard to say [the study] has any insights for the U.S., but this certainly seemed like a safe option for them and how they implemented it.
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