1.
A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother's own milk for preterm infants in the NICU.
Sun, H, Cao, Y, Han, S, Cheng, R, Liu, L, Liu, J, Xia, S, Zhang, J, Li, Z, Cheng, X, et al
Trials. 2020;(1):170
Abstract
BACKGROUND Necrotizing enterocolitis (NEC) is the leading cause of death among preterm infants born at < 30 weeks' gestation. The incidence of NEC is reduced when infants are fed human milk. However, in many neonatal intensive care units (NICUs), it is standard practice to freeze and/or pasteurize human milk, which deactivates bioactive components that may offer additional protective benefits. Indeed, our pilot study showed that one feed of fresh mother's own milk per day was safe, feasible, and can reduce morbidity in preterm infants. To further evaluate the benefits of fresh human milk in the NICU, a randomized controlled trial is needed. METHODS Our prospective multicenter, double-blinded, randomized, controlled trial will include infants born at < 30 weeks' gestation and admitted to one of 29 tertiary NICUs in China. Infants in the intervention (fresh human milk) group (n = 1549) will receive at least two feeds of fresh human milk (i.e., within 4 h of expression) per day from the time of enrollment until 32 weeks' corrected age or discharge to home. Infants in the control group (n = 1549) will receive previously frozen human milk following the current standard protocols. Following informed consent, enrolled infants will be randomly allocated to the control or fresh human milk groups. The primary outcome is the composite outcome mortality or NEC ≥ stage 2 at 32 weeks' corrected age, and the secondary outcomes are mortality, NEC ≥ stage 2, NEC needing surgery, late-onset sepsis, retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), weight gain, change in weight, increase in length, increase in head circumference, time to full enteral feeds, and finally, the number and type of critical incident reports, including feeding errors. DISCUSSION Our double-blinded, randomized, controlled trial aims to examine whether fresh human milk can improve infant outcomes. The results of this study will impact both Chinese and international medical practice and feeding policy for preterm infants. In addition, data from our study will inform changes in health policy in NICUs across China, such that mothers are encouraged to enter the NICU and express fresh milk for their infants. TRIAL REGISTRATION Chinese Clinical Trial Registry; #ChiCTR1900020577; registered January 1, 2019; http://www.chictr.org.cn/showprojen.aspx?proj=34276.
2.
Efficacy of rhubarb combined with early enteral nutrition for the treatment of severe acute pancreatitis: a randomized controlled trial.
Wan, B, Fu, H, Yin, J, Xu, F
Scandinavian journal of gastroenterology. 2014;(11):1375-84
Abstract
OBJECTIVE To investigate the effect of rhubarb combined with early enteral nutrition (EEN) on the gastrointestinal function, disease severity and systemic inflammation in patients with severe acute pancreatitis (SAP). METHODS A total of 126 patients with SAP were randomly assigned into three groups: parenteral nutrition group, treated with standard solution first and EN 14 days later; EEN group, treated with EN suspension; or EEN combined with rhubarb group, treated with rhubarb and then EN 2 h later. The gastrointestinal function, APACHE II scores, the levels of plasma IL-6, IL-11, C-reactive proteins (CRP) and the liver and kidney functional measures were longitudinally analyzed. RESULTS Patients in the EEN/rhubarb group had the shortest period of abdominal pain and the fastest recovery from abnormal bowel movement and high fever as well as significantly shorter periods of intensive-care unit and hospital stays. The combination of EEN and rhubarb significantly reduced the values of APACHE II scores. Combination therapies significantly reduced abnormally higher white blood cell (WBC) counts and levels of plasma CRP and IL-6, but increased the levels of plasma IL-11. Finally, combination therapies improved the SAP-related damages of liver and kidney function by reducing abnormally higher levels of plasma alanine aminotransferase, aspartate aminotransferase, and creatinine (Cr). CONCLUSION Combination of EEN and rhubarb significantly improved the gastrointestinal function, inhibited systemic inflammation and disease severity and mitigated the disease-related damages of liver and kidney function in SAP patients.