Sodium + Milk Fortification for Premature Birth

(SAFE Trial)

This trial explores whether adding sodium to the diet of very premature infants can enhance growth compared to using fortified milk alone. Researchers will compare two groups: one will receive targeted sodium supplementation (a specific increase in sodium intake) with regular testing, while the other will receive enriched milk fortification. The trial focuses on improving growth and body composition. Eligible participants are infants born very early (between 24 and 31 weeks) who are currently on full milk feeds in the NICU at the University of Washington, Oregon Health and Sciences, or the University of Cincinnati. As an unphased trial, this study provides a unique opportunity to contribute to important research that could improve the growth and development of very premature infants.

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

Past studies on giving extra sodium to preterm infants have shown mixed results. Some research suggests it can aid weight gain and growth in the hospital. However, one study found no significant improvement in growth, such as weight and length, from sodium supplementation. Sodium can be safely administered to preterm babies with close monitoring.

Regarding milk fortification, evidence shows it is generally safe and beneficial for preterm infants. Adding nutrients to human milk has been linked to lower death rates and fewer serious health issues. However, some studies warn that early fortification might increase the risk of digestive problems, such as difficulty tolerating feeds.

Researchers are excited about these treatments for premature birth because they offer a tailored approach to nutritional support. The targeted sodium supplementation method stands out by using regular sodium testing to customize sodium intake based on each infant's needs, potentially improving growth outcomes more effectively than standard methods. On the other hand, enriched milk fortification ensures that milk is fortified according to growth metrics, providing a more personalized nutrition plan. These strategies aim to optimize the nutritional intake for premature infants, which could lead to better overall health and development.

This trial will compare targeted sodium supplementation with enriched milk fortification for premature birth. Research has shown that early sodium supplements can help preterm babies gain weight and grow better. Adjusting sodium levels based on urine tests may further accelerate growth. One study found that preterm babies receiving sodium supplements gained weight and grew in length more effectively. However, another study found that sodium supplements did not consistently improve growth in very preterm babies. Despite mixed results, the potential benefits of targeted sodium supplements for growth in premature babies remain promising.⁶⁷⁸⁹¹⁰