Milk temperature reducing necrotizing enterocolitis in very preterm infants: study protocol for a randomized controlled trial.

Abstract

Background: Necrotizing enterocolitis (NEC) is a common and serious gastrointestinal condition among preterm infants. Factors such as infection, inflammation, and improper feeding are believed to contribute to its onset, but its precise pathophysiology remains unclear. Cold exposure, including feeding at low temperatures, has been associated with increased risks of NEC, yet the direct relationship between feeding temperature and NEC development remains underexplored. This study aims to assess the impact of thermostatic versus standard feeding on the incidence of stage 2 or higher NEC in very preterm infants.

Methods: This randomized controlled trial involves preterm infants (< 32 weeks gestational age) admitted to a neonatal intensive care unit. Participants are randomly assigned to receive either thermostatic feeding, with milk maintained at a set temperature throughout feeding, or standard feeding, where milk is allowed to reach room temperature. Both breast milk and formula are used based on clinical guidelines. Primary outcomes include the incidence of ≥ stage 2 NEC, while secondary outcomes involve the incidence of bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP) > 2nd stages, intraventricular hemorrhage (IVH) > 2nd grades, time to achieve total gastrointestinal nutrition, weekly weight growth, frequency of feeding intolerance, extrauterine growth restriction, and late-onset sepsis.

Expected results: The study expects to identify a significant reduction in NEC incidence among infants receiving thermostatic feeding compared to those in the standard feeding group. Additionally, improvements in feeding tolerance, weekly weight growth, and time to achieve full gastrointestinal nutrition are anticipated.

Conclusion: This study aims to clarify the relationship between feeding temperature and NEC risk, potentially influencing future neonatal care guidelines. By identifying optimal feeding practices, this trial aims to reduce the morbidity and mortality associated with NEC in very preterm infants.