Improving Early Nutrition for Extremely and Very Preterm Infants Using a New Feeding and Supplement Plan

What this Trial Is About

Extremely and very preterm infants have higher nutritional needs and fewer reserves compared to full-term infants, making them vulnerable to nutritional deficiencies that can negatively impact organ development, growth, and neurodevelopment. This research aims to improve clinical outcomes for these infants by testing a quality improvement bundle based on best clinical practices, focusing on early nutrition management. The study is a real-world interventional trial conducted by the Childrens Hospital of Fudan University to explore the effects of this bundle on growth, organ function, and neurodevelopmental outcomes. The study compares two groups an intervention group receiving an enhanced nutritional bundle including individualized human milk feeding, early enteral zinc supplementation, and routine parenteral carnitine supplementation, and a control group receiving conventional nutritional strategies from historical data. The intervention is integrated with routine nutritional support and aims to optimize both enteral and parenteral nutrition during the early postnatal period. The control group received standard care without the special bundle. Participants will be monitored from birth until discharge, with assessments including weight, length, head circumference, and incidence of growth-related complications at approximately corrected gestational age of 36 to 42 weeks. Additional measurements include blood levels of zinc, carnitine, and albumin at various intervals, intestinal metabolic status weekly until discharge, and neurodevelopmental outcomes at 12 months corrected age. The primary outcome is the change in weight z-score from birth to discharge, with safety and growth outcomes tracked throughout the study period until 2029.

Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants