Nutrition of Premature Infants With Human Breastmilk Fortifier With Higher Protein Content and Long Chain Poli- Unsaturated Fatty Acids (LCPUFA)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Weight and linear growth
研究概览
简要总结
The objective of the study is to compare two human milk fortifiers with different protein content and LCPUFA in a group of very low birth weight infants.
详细描述
This study is a multi-center, third party-blinded, randomized, controlled, parallel- group, prospective trial comparing growth with a liquid human milk fortifier with higher protein content and LCPUFA and a control powdered human milk fortifier added to breast milk and fed to premature infants. The trial will be conducted in 11 centers in Chile. The enrollment period is expected to be approximately 18 months. To allow for dropouts, approximately 160 participants will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 3 Days 至 40 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infant equal or under 31 weeks gestational age at birth
- •Birth weight equal or under 1,250 g
- •Predominantly fed breast milk (mother's milk or donor milk) on study day 0
- •Appropriate birth weight for gestational age (AGA) - defined as birth weight between and inclusive of the 10th and 90th percentiles on the Fenton growth chart
- •Singleton or twin birth (both twins do not need to qualify and be randomized into study)
- •Birth weight is ≤1,000 g and participant is ≤ 40 days of age on study day 0
- •Birth weight is above 1,000 g and participant is ≤ 30 days of age on study day 0
- •Enteral intake of 80 mL/kg/d of unfortified breast milk on study day 0
- •Anticipate mother's willingness to breast milk for at least 28 days from study day 0
- •Signed informed consent obtained
排除标准
- •History of underlying metabolic or chronic disease, congenital malformation, or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the participant to ingest food, normal growth and development of the participant, or the evaluation of the participant
- •5 minute APGAR score ≤ 4
- •Major surgery that required general anesthesia prior to first day study (note: persistent ductus arterious ligation is allowed)
- •Received pharmacologic doses of glucocorticoids during 3 consecutive days (72 hours) prior to or on day one of study (physiologic hydrocortisone administration up to 1.5 mg/kg/d is permitted)
- •Ventilator-dependent and requiring ≥ 40% fraction of inspired oxygen (FiO2) on day one of study (ventilator dependent and requiring ≤ 40% FiO2 and/or nasal canula, and/or nasal continous positive airway pressure (CPAP) and/or oxygen hood is allowed)
- •Grade III or IV bilateral intraventricular hemorrhage (IVH) prior to or on study day one
- •Feeding intolerance to breast milk feedings on study day one
- •Consumption of more than 3 feedings or 12 hours of continuous feeds of fortified breast milk prior to study day one
- •Fluid restriction < 120 mL/kg/d
- •History of creatinine >2.0 mg/dL 7 days prior to or on study day one
- •Currently receiving or plan use of probiotics
结局指标
主要结局
Weight and linear growth
时间窗: between entering study and 45 days in study or discharge, whatever first
Weight increase in g/K/day and knee-to-heel length increase in mm/weeks, measured in one scale (+-5 g) and one kneenometer (special device to measure longitude) (+- 1mm) by one person for each center between entering study and 45 days in study or discharge
次要结局
- Compare feeding tolerance(Between entering study and 45 days in study or discharge, if discharge first)
- Compare length of hospital- stay(days from the first day of study to discharge home , an average of 37 weeks of postconceptual age)
- Compare incidence of main preterm morbidities: necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and sepsis(Between entering study and 45 days in study or discharge, if discharge is first)
- Compare cost/benefits . The cost of use a fortificant and the benefit of growth velocity(Between entering study and 45 days in study or discharge, if discharge is first)
研究者
Patricia Mena Nannig
MD
NEOCOSUR