RESUMO
Objective:To evaluate the clinical efficacy of extensively hydrolyzed protein formula(eHF) in very low birth weight(VLBW) infants.Methods:A prospective controlled signal-center trial was conducted in this study, the preterm infants with gestational age of 28-33 weeks and birth weight of 999-1 500 g who were hospitalized at Department of Neonatology, Zhuhai Maternal Hospital within the first 12 hours between January and December 2018, were selected.They were assigned into breast feeding group(HM) and formula feeding group according to the mothers′ disease and parents′ breastfeeding willingness.The formula feeding group was assigned into eHF group and preterm formula (PF)group according to the parents′ breastfeeding willingness.The infants discharging or dead before achieving full feeding, discharging within 28 days after birth, with congenital malformation (complex congenital heart disease, digestive system malformation, etc) and severe sepsis were rolled out. Chi- square test and One- Way ANOVA were used for statistical analysis.Prospective study was conducted among the 3 groups comparing the incidence of feeding intolerance, duration of meconium discharge, the time to regain birth weight and reach full enteral feeding, average hospital stay, incidence of necrotizing enterocolitis of newborn(NEC), cholestasis and extrauterine growth retardation(EUGR), the growth rate of head circumference, length and weight in the first 4 weeks of life, and blood biochemical indices at the first 2 weeks and 4 weeks of life. Results:A total of 102 infants were enrolled, 35 cases in the eHF group, 37 cases in the PF group and 30 cases in the HM group.Compared with the PF group [54.0%(20/37 cases)], the eHF group[22.0%(8/35 cases)] and the HM group [16.7%(5/30 cases)] had lower incidence of feeding intolerance, and the differences were statistically significant( χ2=7.366, 9.901, all P<0.05). The time to regain birth weight[(8.9±1.8) d, (9.1±1.4) d vs.(10.8±2.9) d], time for achieving full enteral feeding [(42.8±2.8) d, (42.3±3.3) vs.(45.5±3.4) d], the duration of meconium discharge [(7.2±1.8) d, (6.6±1.8) d vs.(8.7±2.1) d], and average hospital stay [(52.9±1.1) d, (52.3±1.2) d vs.(54.1±1.2) d]in the eHF group and HM group were shorter than those in PF group, and the differences were statistically significant(all P<0.05); and there was no statistically significant difference between the eHF group and the HM group(all P>0.05). There was no statistically significant difference in the incidence of incidence of NEC, cholestasis and EUGR, the growth rate of head circumfe-rence, length and weight in the first 4 weeks of life, the serum albumin, creatinine, urea nitrogen at first 2 weeks and 4 weeks of life among the 3 groups (all P>0.05). Compared with the PF group, the serum total bilirubin levels in the eHF group and the HM group were lower at 2 weeks [(109.4± 4.6) μmol/L, (110.2±1.0) μmol/L vs.(115.0±7.6) μmol/L]and 4 weeks after birth[(79.3±9.7) μmol/L, (80.0±1.7) μmol/L vs.(81.5±8.4)μmol/L], and the differences were statistically significant(all P<0.05), but no statistically significant difference was found between the eHF goup and the HM group(all P>0.05). Conclusions:For VLBW infants, eHF can reduce feeding intole-rance, promote defecation, achieve full feeding faster, promote bilirubin metabolism, shorten hospital stay, does not affect growth and development in short-term.