Fortini Formula for Single Ventricle Heart

This trial tests a special formula called Fortini to determine if it helps high-risk babies with complex heart conditions grow better after their first surgery. Babies with single ventricle heart issues often struggle to gain weight, highlighting the importance of this study. Researchers will divide participants into two groups: one will receive the Fortini formula, and the other will receive a standard high-calorie formula. The main goal is to assess whether Fortini promotes more effective growth and to evaluate how well babies tolerate the formula. This trial suits babies who have had their first heart surgery, are stable, ready for hospital discharge, and are feeding by mouth or tube. As an unphased trial, it offers a unique opportunity to contribute to important research that could improve growth outcomes for high-risk infants.

The trial information does not specify whether participants must stop taking their current medications. It focuses on testing a special formula for infants with specific heart conditions.

A previous study found the Fortini formula to be safe and well-tolerated in infants, especially those who underwent heart surgery. Babies who used Fortini gained weight effectively within 30 days after surgery for a congenital heart defect. The formula improved their growth, which is crucial after such surgeries. No major side effects were reported, making it a promising option for babies with similar conditions. Thus, Fortini could be a safe choice for infants needing extra nutritional support to grow well after heart surgery.¹²³⁴⁵

Fortini Formula is unique because it provides a concentrated 30 kcal/oz, which is higher than many standard infant formulas that typically offer 24-30 kcal/oz. This higher caloric density could be particularly beneficial for infants with single ventricle heart conditions, who may require more energy to support their growth and development. Researchers are excited about Fortini because it offers a potentially more efficient way to meet the nutritional needs of these infants, possibly leading to improved growth outcomes compared to standard nutritional care.

Research has shown that a formula rich in energy and protein, like Fortini, can help infants who are not growing well to gain weight. In this trial, some participants will receive the Fortini formula, a commercially available formula providing 30 kcal/oz. Studies have found that infants consuming these nutrient-rich formulas after heart surgery tend to grow better than those consuming regular formulas. Other participants in this trial will receive standard nutritional care, which includes standard infant formulas fortified to 24-30 kcal/oz. Consuming more energy from their diet after heart surgery is linked to better recovery and health. Early evidence suggests that Fortini might be especially beneficial for high-risk infants, such as those with certain heart conditions, to grow better between surgeries.²⁶⁷⁸⁹