Preterm Formula versus Human Milk Fortifier for Fortification of Mother’s Own Milk in Very Low Birth Weight Infants: The PREMFORT Trial
The PREMFORT trial demonstrated that fortifying mother's own milk with preterm formula powder plus supplements is non-inferior to standard human milk fortifier for short-term weight growth velocity in very low birth weight infants while offering an 88% reduction in estimated acquisition costs.
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For the tiniest babies born too soon, the first weeks of life are a race against time. Their bodies are not yet ready to handle the world, and their growth depends entirely on the food they receive. While a mother's own milk is the gold standard for nutrition, it often lacks the specific density of protein, minerals, and energy that a very small, premature infant needs to thrive. To bridge this gap, doctors in neonatal intensive care units add a supplement to the milk, a process known as fortification. This extra boost helps the baby gain weight and grow stronger. However, the standard supplements used in many hospitals are expensive and sometimes difficult to obtain, particularly in lower-income regions. This creates a dilemma: how can doctors ensure these fragile infants grow well without relying on costly products that might run out?
Researchers in India set out to solve this problem by testing a different approach. They wondered if a preterm baby formula powder, mixed into the mother's milk, could work just as well as the standard commercial supplement. This formula powder is a common, affordable product used for feeding babies who cannot breastfeed, but it was not originally designed to be mixed into breast milk. The team hypothesized that if they added this powder to the mother's milk and also gave the babies specific vitamins and minerals to make up for what the powder lacked, the babies would grow at the same speed as those receiving the expensive commercial supplement. This question matters deeply because finding a cheaper, reliable alternative could mean more babies in resource-limited settings get the nutrition they need to survive and develop.
The study, conducted at a single hospital in Aurangabad, followed 164 very low birth weight infants, all born before 34 weeks and weighing less than 1,500 grams. The researchers divided these babies into two groups. One group received their mother's milk fortified with a standard commercial bovine human milk fortifier. The other group received their mother's milk fortified with a preterm formula powder, along with extra calcium, phosphorus, vitamin D, and a multivitamin to ensure their nutritional needs were fully met. The babies were monitored from the time they started the fortified milk until they were ready to leave the hospital or reached 40 weeks of age. The primary goal was to measure how fast the babies gained weight, a critical indicator of their health and development.
The results showed that the babies in the formula group grew almost as fast as those in the commercial fortifier group. The commercial group gained weight at an average rate of about 13.96 grams per kilogram of body weight per day, while the formula group gained about 13.29 grams per kilogram per day. Although the formula group grew slightly slower, the difference was small enough that the researchers concluded the formula strategy was not worse than the standard method. In statistical terms, the study demonstrated non-inferiority, meaning the cheaper option fell within a pre-specified acceptable margin and was considered a valid alternative. The growth in length and head size was also similar between the two groups, and there were no significant differences in serious health problems like infections, bleeding in the brain, or feeding intolerance.
Beyond the growth numbers, the study highlighted a dramatic difference in cost. The estimated cost to provide the commercial fortifier was roughly 4,838 Indian rupees per infant, whereas the cost for the preterm formula powder plus the necessary supplements was only about 580 rupees per infant. This represents an 88 percent reduction in the direct cost of the intervention. The researchers noted that while the study was open-label, meaning the caregivers knew which treatment the babies were receiving, the measurements of the babies' growth were taken by staff who did not know which group the babies belonged to, ensuring the data remained objective.
This work adds a significant piece of evidence to a field where data has been mixed and often uncertain. While some previous small studies had suggested similar results, this trial was larger and more rigorously designed to specifically test if the cheaper method was truly comparable. The findings suggest that in places where commercial fortifiers are too expensive or unavailable, using a preterm formula powder with targeted vitamin and mineral supplements is a practical and effective strategy. It allows hospitals to continue providing fortified breast milk to their smallest patients without compromising their short-term growth. However, the researchers caution that this conclusion applies to the specific period of hospitalization, and more large-scale studies are needed to see if these babies continue to grow well and develop normally after they go home.
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