Neonatal-Perinatal Fellow Norton Children’s Hospital Louisville, Kentucky, United States
Background: Necrotizing enterocolitis (NEC) is an acute inflammatory gastrointestinal disease which primarily affects preterm infants and is one of the leading causes of morbidity and mortality in the neonatal intensive care unit. An experimental model of NEC in rats demonstrated that pups fed with chow supplemented with relaxin demonstrated substantially increased ileal perfusion and less histologic NEC. It was concluded that oral relaxin supplementation may have a role in the prevention of or serve as a rescue therapy for NEC (Matheson et al, J. Ped. Surg, 2014). Relaxin [H2] is a hormone belonging to the insulin family and has been identified in human milk. In a landmark study in 1989, Eddie, et al. found relaxin concentrations to be around 50 pg/ml +/- 3 in maternal breast milk. Like maternal breast milk, donor breast milk (DBM) has been associated with a reduction in necrotizing entercolitis in preterm infants. Prior to use, DBM is pasteurized. The pasteurized milk retains many beneficial and protective components but the pasteurization process also affects nutritional and biological properties of human milk. It is not known if relaxin is a protein affected by pasteurization. Objective: To determine if human relaxin is present in pasteurized DBM. Design/Methods: Deidentified maternal breast milk samples and donor breast milk samples from different lots are to be obtained from the NICU. Quantitative analysis will be done using a human relaxin-2 ELISA test according to the kit instructions. Measurement of the concentration of the relaxin in the test sample will be compared to a standard curve. The number of samples needed for this study was determined using SPSS SamplePower. If an expected 10% difference in the amount of relaxin is found in the stored breast milk samples, using a t—test for paired samples, 15 samples per group are required to produce a study with close to 100% power. Statistical analysis will be performed with SPSS. Descriptive statistics will be applied. Statistical significance will be set at p £ 0.05.
