ArticleTrials2020
A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother's own milk for preterm infants in the NICU.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 15 citations in OpenAlex.
- The effects of nutrition on mesenteric oxygenation among neonates with neonatal encephalopathy: a randomized clinical trial.Pediatric research · 2025Trial
- Early versus delayed enteral nutrition for neonatal hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia: a randomized controlled trial.Italian journal of pediatrics · 2022Trial
- Human Milk Practices in Swedish Neonatal Units: Results From a Nationwide Survey.Acta paediatrica (Oslo, Norway : 1992) · 2026Article
- Enteral feeding timing and clinical outcomes in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia: a retrospective cohort study highlighting the challenge of confounding by indication.Frontiers in pediatrics · 2026Article
- Point-of-care human milk concentration by passive osmosis: comprehensive analysis of fresh human milk samples.Journal of perinatology : official journal of the California Perinatal Association · 2024Article
- Article
- Research progress on pathophysiologic mechanisms, clinical treatment and predictive biomarkers in bronchopulmonary dysplasia: from the perspective of oxidative stress.Frontiers in pediatrics · 2024Review
- Exosome-Derived MicroRNAs of Human Milk and Their Effects on Infant Health and Development.Biomolecules · 2021Review
- Racial and socioeconomic disparities in breast milk feedings in US neonatal intensive care units.Pediatric research · 2021Review
- Dose-dependent effect of human milk on Bronchopulmonary dysplasia in very low birth weight infants.BMC pediatrics · 2020Article
- Impact of Storage Conditions on the Breast Milk Peptidome.Nutrients · 2020Article
Corrections and comments
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Authors and funding
35 authors at 20 institutions in 3 countries.
Funding
Abstract
backgroundNecrotizing 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.
methodsOur 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 registrationChinese Clinical Trial Registry; #ChiCTR1900020577; registered January 1, 2019; http://www.chictr.org.cn/showprojen.aspx?proj=34276.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.