Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
试验速览
- 阶段
- 不适用
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Return to birth weight day
研究概览
简要总结
The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier grow according to established guidelines and maintain adequate micronutrient levels.
详细描述
To achieve this goal, the investigators will prospectively analyze the growth and micronutrient status of VLBW infants who are fed human milk (maternal or donor) supplemented with a human-milk-based fortifier with increased protein (Medolac® Human Milk Fortifier). In addition, the investigators will compare the findings to retrospectively collected data for growth rates and micronutrient status of infants who received human milk fortified with cow's milk -based fortifier (Enfamil® Hydrolyzed Liquid Human Milk Fortifier). The investigators hypothesize that a human milk-based fortifier with increased protein will support growth at recommended levels (weight gain of 12-18 g/kg/day, head circumference 0.75-1.0 cm/week, length 0.8-1.1 cm/week)[1-3] and prevent micronutrient deficiency in the VLBW infant
Aim 1: To determine if VLBW infants fed human milk, maternal or donor, supplemented with a human milk-based fortifier with increased protein grow at recommended levels for weight, length, and head circumference. To achieve this aim, Z-scores for weight, length, and head circumference will be tracked. Measurements will be taken at birth and then weekly until 36 weeks post-menstrual age (PMA) or discharge from the neonatal intensive care unit (NICU), whichever comes first. Aim 2: To measure nutritional status in VLBW premature infants fed human milk supplemented with a human milk-based fortifier with increased protein. To achieve this aim, serum magnesium, potassium, chloride, blood urea nitrogen (BUN), creatinine, sodium, calcium, phosphorus, CO2, Vitamin D 1, 25 (OH) 2D, parathyroid hormone (PTH), alkaline phosphatase, hemoglobin, hematocrit will be measured within 24 hours of reaching full enteral feedings and repeated seven days later, and then every fourteen days until 36 weeks PMA or discharge, whichever comes first. Urine magnesium and sodium will be measured on the same schedule.
Aim 3: To compare growth rates and nutritional status of VLBW infants fed human milk fortified with a human milk-based fortifier to growth rates and nutritional status of those fed human milk fortified with a cow's milk-based fortifier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight 750-1800 grams
- •Admitted to AU NICU within 24 hours of life
- •Estimated gestational age (EGA) 23 to 33 weeks as confirmed by the Ballard score
- •Birth weight appropriate for gestational age (AGA) defined as >3rd% on a gender-specific Fenton growth curve (Fenton 2013, Calgary, Canada)
- •Enteral feedings initiated within 7 days of life
- •Breastmilk diet, maternal or donor milk
排除标准
- •Renal conditions affecting electrolyte metabolism and/or excretion
- •Gastro-intestinal conditions that preclude feeding or affect nutrient absorption (gastroschisis, omphalocele)
- •EGA >33 weeks or birth weight >1800 grams or EGA <23 weeks or birth weight <750 grams
- •Apgar <3 at 5 minutes
- •Grade 3 or higher intraventricular hemorrhage (IVH)
- •Intrauterine growth restriction (IUGR), as defined as <3rd% on a gender-specific Fenton growth curve
- •Congenital anomalies including congenital heart disease or other major defect requiring surgical intervention
- •Intake of cow's milk formula or fortifier before or after the initiation of the study protocol
研究组 & 干预措施
Retrospective Chart Review
Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier
Prospective
All neonates with birth weights ranging from 750-1500 grams and gestational ages 23-33 weeks admitted to the NICU at Augusta University within 24 hours of life will be eligible for screening within 72 hours of admission and upon parent's or legal guardian's consent.
Infants will be fed a human milk fortifier made with donor human milk. Data will be compared with historic control data.
干预措施: Human milk based human milk fortifier (Other)
结局指标
主要结局
Return to birth weight day
时间窗: birth to 30 days
Day of life infant returns to birth weight
Growth Velocity
时间窗: Weekly until 36 weeks post menstrual age or discharge
rate of weight gain measured as g/kg/day
Mean Serum Magnesium
时间窗: Every 14 days until 36 weeks post menstrual age or discharge
Serum and urine Magnesium
Mean Serum CO2
时间窗: Every 14 days until 36 weeks post menstrual age or discharge
Serum CO2
次要结局
- Mean serum parathyroid Hormone (PTH)(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean serum Potassium(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean serum Alkaline Phosphatase(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean z-scores(Weekly until 36 weeks post menstrual age or discharge)
- Mean serum Hematocrit(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean serum Vitamin D, 1 25 (OH) 2D(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean serum Sodium(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean serum Blood Urea Nitrogen (BUN)(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean serum Calcium(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean serum Phosphorus(Every 14 days until 36 weeks post menstrual age or discharge)
- Mean serum Hemoglobin(Every 14 days until 36 weeks post menstrual age or discharge)
研究者
Amy Gates
Registered Dietitian and Pediatric Nutrition Specialist
Augusta University