German Clinical Trials Register

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Brief summary in lay language

Preterm infants require special care and nutrition. An optimal nutrition plays a key role at the neonatal intensive care. Nutrition influences growth, brain development and the risk of cardiovascular disease and obesity later in life. Research shows that preterm infants can often develop postnatal growth ristriction. Therefore, the goal in nutritional management is to support growth in the best possible way to reach optimal amount and composition of nutrients. Breast milk is best for term infants. In addition, breast milk has health-promoting components that formula milks lack. Preterm infants grow up to four times faster than term infants. As a result, preterm infants have an increased need for nutrients. Therefore, breast milk must be fortified for preterm infants. Several commercial fortifiers are manufactured from cow's milk. However, feding cow's milk products to preterm infants seems to be associated with an increased risk of inflammatory bowel disease and infection. In particular, necrotizing enterocolitis (NEC) may occur. This disease is life-threatening, often leads to abdominal surgery, prolongs hospital stay, and does not positively affect lifelong health. Commercial liquid fortifiers made from pasteurized breast milk are already available for specific applications. These liquid fortifiers replace the own valuable breast milk. Almost half of the prterm infant‘s diet consists of the liquid fortifier instead of the mother's own milk. Recently, a fortifier powder made from donor breast milk has become available. This powder enables a cow's milk-free diet. The powder is dissolved in the breast milk to fortify it. In this process, the premature baby receives only its own fortified breast milk. The natural components of the breast milk are thus preserved. This study is being conducted to determine whether preterm infants develop equally or better with the new fortifier powder made from donor milk than with conventional fortifiers. It is then randomly selected whether the participating preterm infants receive either the fortifier based on donor milk or the conventional product. In our study, measurements that are collected anyway in routine clinical practice will be evaluated. These are measurements of nutrition, growth, fat mass, health, but also blood and urine parameters.

Brief summary in scientific language

Breast milk is the recommended nutrition for preterm infants. To meet their increased nutritional needs compared to mature infants, breast milk must be fortified with protein, energy, and minerals. Cow's milk protein used in most commercial fortifiers increases the risk of necrotizing enterocolitis in preterm infants. A fortifier made from human milk could reduce this. Recently, freeze-dried human milk powder has become available as a nutritional supplement. The aim of this study is to compare growth, feeding tolerance, and metabolic parameters between the new fortifier based on donor breast milk and previous standard fortifiers. Methods This multicenter, randomized, controlled clinical trial will be conducted. N=240 preterm infants will be recruited. Preterm infants receiving fortified breast milk and at least 75% of the daily enteral feeding volume from fortified breast milk. Exclusion criteria are syndromal diseases, gastrointestinal diseases with possible impairment of absorption of nutrients and gram-negative sepsis. Outcome parameters for growth, nutrient intake, feeding tolerance, metabolism, length of hospital stay and diseases will be analyzed.