Journal Article

A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother’s own milk for preterm infants in the NICU

Xu, Falin, Zhou, Qi, Xia, Shiwen, Wang, Laishuan, Lee, Shoo K., Yu, Fengqin, Cheng, Rui, Li, Mingxia, Li, Zhankui, Zhang, Jiajie, Cheng, Xiuyong, Han, Shuping, Ding, Xin, Wang, Rensheng, Wei, Mou, Pan, Xinnian, Shi, Liping, Li, Li, Liu, Ling, Zhang, Xiaolan, Wu, Mingyuan, Unger, Sharon, Lu, Jiao, Li, Long, Pan, Jiahua, Ye, Xiang Y., Li, Xiaoying, Sun, Huiqing, Yang, Chuanzhong, Liu, Jiangqin, Yan, Changhong, Yang, Jie, Cao, Yun, Kakulas, Foteini, Yang, Ling

2020

Overview

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

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Biomedicine / Birth weight / Breast milk / Breast milk, Preterm, Necrotizing enterocolitis, Neonatal intensive care unit (NICU) / Bronchopulmonary dysplasia / Carbohydrates / Care and treatment / Children & youth / Childrens health / Clinical trials / Consent / Death / Double-Blind Method / Dysplasia / Enteral Nutrition - methods / Enterocolitis / Enterocolitis, Necrotizing - diagnosis / Enterocolitis, Necrotizing - epidemiology / Enterocolitis, Necrotizing - physiopathology / Enterocolitis, Necrotizing - prevention & control / Female / Food and nutrition / Food Preservation - methods / Freezing - adverse effects / Gastrointestinal diseases / Gestational Age / Health aspects / Health policy / Health Sciences / Hospital Mortality / Hospitals / Humans / Hypotheses / Infant / Infant Mortality / Infant, Newborn / Infant, Premature - physiology / Infants / Infections / Informed consent / Intensive care / Intensive Care Units, Neonatal - statistics & numerical data / Legal fees / Maternal & child health / Medicine / Medicine & Public Health / Milk, Human - physiology / Morbidity / Mortality / Mothers / Necrosis / Necrotizing enterocolitis / Neonatal care / Neonatal intensive care / Neonatal intensive care units / Newborn babies / Newborn infants / Nutrition / Palliative care / Pregnancy / Premature babies / Premature infants / Prospective Studies / Randomized Controlled Trials as Topic / Retinopathy of prematurity / Retirement benefits / Services / Severity of Illness Index / Statistics for Life Sciences / Stem cells / Study Protocol / Surgery / Testing / Time / Treatment Outcome