Einfluss Von Geschlecht Und Pasteurisierung Auf Das Neonatale Outcome Bei Frühgeborenen Unter 1.500 g: Retrospektive Analyse Zur Bedeutung Der Muttermilch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Severe Morbidity (NEC, Sepsis, BPD, ROP)
研究概览
简要总结
In very low birth weight (<1500g) preterm infants, nutrition with mother's own milk, as opposed to formula, is associated with reduced morbidity and mortality. At present, the merits and risks of pasteurising mother's own milk (recommended if the mother is positive for cytomegalovirus) are unknown. This single-institution retrospective analysis aims at comparing mortality and morbidity of preterm infants below 1500g birth weight who were fed raw (unpasteurized) or pasteurized mother's own milk (in case the mother is positive for cytomegalovirus). The infant's sex into is taken into account as a possible confounder.
详细描述
Retrospective analysis of preterm infants below 1500g birth admitted 2019-2024 to the Department of Neonatology at the Charité - Universitätsmedizin Berlin. Infants with major congenital malformation, chromosomal aberrrations and known genetic conditions are excluded. Input variables are basic demographic data (gestational age, birth weight, sex, antenatal steroids, and others), duration of mother's own milk feeding, duration of donor milk feeding, cytomegalovirus status of the mother, pasteurization of mother's own milk (start and end date), main outcome variables are death, major surgery, necrotizing enterocolitis, duration of antibiotic treatment, duration of positive pressure ventilation, duration of oxygen supplementation, duration of hospital treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Preterm infants Birth weight below 1500g Admitted to Charité Universitätsmedizin Berlin Year of birth 2019-2024
排除标准
- •Major congenital malformations Chromosomal aberrations Known genetic conditions
结局指标
主要结局
Severe Morbidity (NEC, Sepsis, BPD, ROP)
时间窗: up to 24 weeks or discharge from hospital, whatever occurs first
Necrotizing enterocolitis (requiring surgery), sepsis (blood culture-positive), bronchopulmonary dysplasia (requirement for oxygen supplementration at 36 weeks postmenstrual age), severe retinopathy (grade 3 or treatment with laser or intravitreal anti-VEGF agents)
次要结局
- Duration of parenteral nutrition, duration of positive pressure ventilation, duration of supplemental oxygen, duration of hospitalization(up to 24 weeks or discharge from hospital, whatever occurs first)
研究者
Christoph Bührer
Professor
Charite University, Berlin, Germany