Randomised Trial Weight Gain in Extremely Premature Infant: Targeted Versus Adjusted Fortification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Growth rate 28 days after the start of fortification and birth
研究概览
简要总结
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
详细描述
- Study design This is an interventional, randomized, controlled study.
- Description of the study The very premature newborn will be identified by daily evaluation of the infants admitted for consultation in the income book.
Informed consent will be requested from the infant´s father, mother or legal guardian between the fifth and tenth day of life.
Fortification will be done according to the randomization group. 3. Outline of the study design
- Excel calculation sheet of individualized supplementation according to the composition of breast milk in the target fortification group. Methodology of analysis of breast milk in FOSS analyzer.
- In the adjusted fortification group, urea concentration levels will be kept between 19-30 mg / dL
- Fenton curves or https://www.growthcalculator.org/ will be used for Z-scores calculation.
- Growth speed calculation: Weight gain: (1000x ln [Final weight / Initial weight]) / number of days.
4 Duration of the study for each participant The duration of participation in the study and the fortification intervention period will be a maximum of 132 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants born <1000 g of birth weight that are fed with breast milk or donated milk.
- •Written informed consent signed by the mother, father or legal guardian.
- •To tolerate enteral feeding, at least 100mL / kg / day.
排除标准
- •Non-premature or premature patients weighing ≥ 1000 gr.
- •Patients with major malformations.
- •Patients with diagnosed chromosomal diseases or of high diagnostic suspicion.
- •Patients with short bowel syndrome or any surgery on the gastrointestinal tract.
结局指标
主要结局
Growth rate 28 days after the start of fortification and birth
时间窗: 28 days
To investigate the effect on weight gain during admission of individualized fortification, according to milk analysis, versus fortification adjusted according to urea level.
次要结局
- Mineralization differences between both fortication methods(Until 36 weeks of postmenstrual age (EPM) or at discharge)
研究者
Esperanza Escribano
Co-investigator
Hospital Universitario La Paz