Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Assessment of infants' growth
研究概览
简要总结
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is insufficient, has a positive impact on infants' protein intake, growth and morbidity.
详细描述
Mother's own milk (MOM) is the optimal nutrition for preterm infants. When MOM is not sufficient, pasteurized donor milk (DM) is the best alternative according to current recommendations. Donor milk is primarily derived from mothers of term-born infants for the first six months of lactation. However, this term milk presents significant differences compared to preterm human milk which has higher protein concentration and more caloric energy.
The investigators hypothesized that feeding VLBW infants with preterm donor milk (PDM) in combination with MOM may positively influence the protein intake and, consequently, the infants' growth. The aim of the current study is to assess whether MOM supplementation with PDM has any beneficial effects on the nutrition, growth and morbidity in VLBW infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •VLBW infants with birth weight <1500g born to mothers who agree to provide donor milk for the first three weeks of life (donor milk period) if their own milk quantity is insufficient
排除标准
- •Congenital anomalies
- •Chromosomal disorders
- •Metabolic diseases
- •Feeding with formula at any point during the first 3 weeks of life (donor milk period)
结局指标
主要结局
Assessment of infants' growth
时间窗: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
Infants' weight gain during hospitalization (grams per day) will be assessed and compared between group A and group B.
Assessment of morbidity
时间窗: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
Culture positive sepsis in study participants during hospitalization will be assessed and compared between group A and group B.
Assessment of protein intake
时间窗: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
Protein intake by the study participants during hospitalization (grams per Kg of body weight per day) will be assessed and compared between group A and group B.
次要结局
未报告次要终点
研究者
Soultana (Tania) Siahanidou
Professor in Pediatrics-Neonatology
National and Kapodistrian University of Athens