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临床试验/NCT02573779
NCT02573779已完成不适用

Intestinal Microbiota and Short Term Outcomes in Very Low Birth Weight Infants Fed Primarily Donor Human Milk Compared to Infants Fed Primarily Mother's Own Milk

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2015年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
2
主要终点
Intestinal Microbiome Diversity

研究概览

简要总结

A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk. The investigators hypothesize that infants who receive primarily their own mother's milk will have better growth, a more diverse intestinal bacterial environment, and possibly some improved short term outcomes such as better feeding tolerance and lower rates of infection.

详细描述

Background: Human milk feeding provides numerous benefits to preterm infants due to improvements in gastrointestinal maturation, host defense, infection rates, and improved long-term outcomes in neurodevelopment as well as cardiovascular and metabolic disease. There is accumulating evidence that an exclusive human milk-based diet decreases the rates of necrotizing enterocolitis (NEC) and death, and is associated with better feeding tolerance in very low birth weight (VLBW) infants than a diet of bovine milk-based products. In order to provide VLBW infants the benefits afforded by human milk feeding, the use of donor milk (DM) in neonatal intensive care units (NICU) has increased as many mothers are unable to provide sufficient milk needed for their premature infants. While there have been numerous studies that have favorably compared feeding of mother's own milk (MOM) to formula as well as studies that compare DM to formula, there are relatively few that compare maternal milk to donor milk.

In regard to feeding tolerance and infection prevention, it has been proposed that DM may be less beneficial than MOM due to reduction in biologically active components during pasteurization, including human milk oligosaccharides (HMOs) and other immunological factors, growth factors, and hormones. Finally, alterations in the intestinal microbiota of preterm infants are suspected to contribute to disease states such as NEC, specifically within infants who have decreased microbial diversity. To the investigators knowledge, no studies comparing the intestinal microbiota among infants fed primarily MOM versus those fed primarily DM have been published.

Purpose: To compare growth velocities, time to reach full enteral feeding volume, intestinal microbiota, and short term outcomes (NEC, late-onset sepsis, white matter injury) between infants fed primarily mother's own milk versus pasteurized donor human milk.

Hypothesis: Infants fed primarily (50% or greater) mother's own milk will have increased intestinal microbiome diversity compared to infants fed primarily pasteurized donor human milk.

Design: This prospective cohort study will be conducted in the Level III NICU at Texas Children's Hospital - Pavilion for Women and the Level II NICU at Texas Children's Hospital -- West Tower. Infants less than 1500 g birth weight will be fed exclusively human milk (mother's milk and or donor breast milk) fortified with donor human milk-derived fortifier per the investigators hospital guidelines. Once enteral feeding is established, infants will be categorized into cohorts based on percentage of feeding volume consisting of mother's own milk, including broad categorization of greater than 50% maternal milk versus less than 50%, and possibly tiered analysis of infants who receive less 25% maternal milk, 25-75% maternal milk, and greater than 75% maternal milk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants less than 72 hours old and less than 1500 g birth weight, who have reasonable expectation of survival and can adhere to a feeding protocol involving mother's own milk and/or donor milk that will include fortification using Prolacta and potentially human cream.

排除标准

  • Exclusion criteria will include birth weight greater than 1500 g, age > 72 hours old, major congenital anomalies, clinically significant heart disease, abdominal wall defects and/or intestinal atresias, severe perinatal hypoxia, or otherwise less than reasonable expectation of survival through the study period.

结局指标

主要结局

Intestinal Microbiome Diversity

时间窗: 6 weeks

Stool samples during the first 6 weeks of life will be analyzed to compare development of microbial diversity

Head Circumference Growth

时间窗: 6-10 weeks

Growth in head circumference will be measured weekly (defined as cm/wk)

Hospital Length of Stay

时间窗: Birth to discharge

Hospital length of stay will be calculated from birth to discharge of infant.

Linear Growth

时间窗: 6-10 weeks

Linear growth will be measured weekly (defined as cm/week)

Weight Gain

时间窗: 6-10 weeks

Weight gain will be evaluated weekly throughout the study (defined as g/kg/day)

次要结局

  • Rates of Spontaneous Intestinal Perforation (SIP)(6-10 weeks)
  • Days to Final Enteral Feed Volume(6-10 weeks)
  • Rates of Necrotizing Enterocolitis (NEC)(6-10 weeks)
  • Rates of Late-onset Sepsis(6-10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Hair

Assistant Professor

Baylor College of Medicine

研究点 (2)

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