Human Milk Cream for Extremely Premature Infants

This trial explores whether adding a special cream made from human milk to the diet of extremely premature infants can help them leave the hospital sooner. The focus is on babies at risk of developing bronchopulmonary dysplasia (BPD), a common lung condition in preemies. Researchers aim to determine if these infants grow better and develop well over time with this added cream. Babies weighing between 500 and 1250 grams at birth who can start certain feedings early may be suitable for this study. As an unphased trial, this study offers families a unique opportunity to contribute to groundbreaking research that could improve outcomes for premature infants.

The trial information does not specify whether participants must stop taking their current medications.

Research has shown that using human milk cream as a supplement for feeding extremely premature babies is generally safe. In one study, babies who received the cream left the hospital sooner, and no major safety issues emerged. This suggests that the cream is likely well-tolerated.

Another study found that human milk-based nutrient fortifiers, like the cream, may help prevent serious health problems in these very early-born babies. While the research highlights benefits, the absence of reported negative effects indicates good safety.

Unlike standard care for extremely premature infants, which typically involves an exclusive human milk (HM)-based diet, the cream supplement being studied adds a human milk-derived cream caloric supplement to this regimen. This supplement is unique because it boosts the caloric intake without introducing foreign substances, potentially aiding in better growth and development for these vulnerable infants. Researchers are excited about this approach because it could offer a more natural and effective way to meet the nutritional needs of extremely premature infants, which is crucial for their early development.

This trial will compare the effects of a human milk-derived cream supplement with a standard human milk-based diet in extremely premature infants. Studies have shown that very premature babies receiving a cream made from human milk tend to have better outcomes. Specifically, babies given this cream alongside their human milk diet gained weight faster and left the hospital sooner. Research also indicates that these babies grow and develop better after returning home. For those at risk of bronchopulmonary dysplasia, the cream may help shorten their hospital stay. Overall, the cream appears to support healthier growth for these vulnerable babies.¹³⁶⁷⁸