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Comparative Study
. 2020 Feb 11;21(1):170.
doi: 10.1186/s13063-019-3981-4.

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

Huiqing Sun  1 , Yun Cao  2 , Shuping Han  3 , Rui Cheng  4 , Ling Liu  5 , Jiangqin Liu  6 , Shiwen Xia  7 , Jiajie Zhang  8 , Zhankui Li  9 , Xiuyong Cheng  10 , Chuanzhong Yang  11 , Xinnian Pan  12 , Long Li  13 , Xin Ding  14 , Rensheng Wang  15 , Mingyuan Wu  16 , Xiaoying Li  17 , Liping Shi  18 , Falin Xu  19 , Fengqin Yu  20 , Jiahua Pan  21 , Xiaolan Zhang  22 , Li Li  23 , Jie Yang  24 , Mingxia Li  25 , Changhong Yan  26 , Qi Zhou  2 , Jiao Lu  27 , Mou Wei  28 , Laishuan Wang  2 , Ling Yang  29 , Xiang Y Ye  30 , Sharon Unger  30   31 , Foteini Kakulas  32 , Shoo K Lee  33   34   35
Affiliations
Comparative Study

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

Huiqing Sun et al. Trials. .

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.

Keywords: Breast milk, Preterm, Necrotizing enterocolitis, Neonatal intensive care unit (NICU).

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT 2013 Schedule of infant enrollment, intervention, and assessment. Abbreviations: -T1 enrollment phase, T1 baseline assessment, T2 32 weeks’ corrected age, T3 completion phase, NEC necrotizing enterocolitis, ROP retinopathy of prematurity, BPD bronchopulmonary dysplasia
Fig. 2
Fig. 2
CMV infection monitoring during human milk feeding
See this image and copyright information in PMC

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