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

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About: A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother’s own milk for preterm infants in the NICU Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother’s own milk for preterm infants in the NICU
Creator	Liu, Ling Yang, Jie Li, Li Li, Xiaoying Unger, Sharon Yang, Ling Li, Long Xia, Shiwen Lu, Jiao Zhou, Qi Li, Zhankui Wang, Laishuan Li, Mingxia Cao, Yun Cheng, Rui Cheng, Xiuyong Ding, Xin Han, Shuping Kakulas, Foteini Lee, Shoo Liu, Jiangqin Pan, Jiahua Pan, Xinnian Shi, Liping Sun, Huiqing Wang, Rensheng Wei, Mou Wu, Mingyuan Xu, Falin Yan, Changhong Yang, Chuanzhong Zhang, Jiajie Ye, Xiang Yu, Fengqin Zhang, Xiaolan
Source	PMC
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
has issue date	2020-02-11(xsd:dateTime)
bibo:doi	10.1186/s13063-019-3981-4
bibo:pmid	32046760
has license	cc-by
sha1sum (hex)	ceade8950b6bc13ec1a236dcc20ca25e9cdf5de0
schema:url	https://doi.org/10.1186/s13063-019-3981-4
resource representing a document's title	A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother’s own milk for preterm infants in the NICU
has PubMed Central identifier	PMC7014600
has PubMed identifier	32046760
schema:publication	Trials
resource representing a document's body	covid:ceade8950b6bc13ec1a236dcc20ca25e9cdf5de0#body_text
is schema:about of	named entity 'fed' named entity 'neonatal intensive care units' named entity 'preterm' named entity 'OUR' named entity 'MORBIDITY' named entity 'PRETERM' covid:arg/ceade8950b6bc13ec1a236dcc20ca25e9cdf5de0 named entity 'human milk' named entity 'weeks' named entity 'hemorrhage' named entity 'bioactive' named entity 'intestine' named entity 'probiotics' named entity 'antioxidant activity' named entity 'retinopathy of prematurity' named entity '4-h' named entity 'preterm infant' named entity 'milk' named entity 'gestation' named entity 'NEC' named entity 'preterm' named entity 'neonatal intensive care units' named entity 'human milk' named entity 'NICU' named entity 'preterm infants' named entity 'NICU' named entity 'milk' named entity 'milk' named entity 'laparotomy' named entity 'data analysis' named entity 'retinopathy of prematurity' named entity 'NICU' named entity 'NICU' named entity 'Carbohydrates' named entity 'Children's Hospital' named entity 'head circumference' named entity 'NEC' named entity 'milk' named entity 'mortality rate' named entity 'carbohydrates' named entity 'NEC' named entity 'pump milk' named entity 'infection' named entity 'human milk' named entity 'preterm infants' named entity 'human milk' named entity 'RCT'

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