Utilizing Targeted Fortification to Evaluate the Effects of a High Versus Standard Protein Diet on Linear Growth and Body Composition in Infants < 1000 g Birth Weight.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Linear growth measured using an premature infant length board
研究概览
简要总结
While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes.
This proposed study will challenge current nutritional regimens for infants < 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants < 1000 g BW.
There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants.
Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and vulnerable infants.
详细描述
Primary Objective: To evaluate the effects of a high versus standard protein enteral diet utilizing targeted fortification on linear growth in infants < 1000 g birth weight (BW).
Hypothesis 1: Infants who receive a high protein diet will have increased length velocity at 36 weeks postmenstrual age when compared to infants who receive a standard protein diet.
Secondary Objective: To evaluate body composition by total body dual energy x-ray absorptiometry (DXA) at 36 weeks postmenstrual age in infants < 1000 g BW who received a high or standard protein enteral diet.
Hypothesis 2: Infants who received a high protein diet will have greater fat-free mass (lean mass) compared to infants who received a standard protein diet.
Protein and energy are key nutrients for growth. A low protein intake or protein to energy ratio may lead to poor linear growth and excess fat accumulation. Studies suggest that preterm infants require a high protein to energy ratio to obtain catch up growth without excessive fat accretion and that growth should focus on length gain and lean body mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 14 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birth weight 500-1000 grams
- •Reasonable expectation of survival for study duration (36 weeks postmenstrual age)
- •Achieve any enteral feedings by 14 days of life
- •Born at our institution or transferred from another institution within the first 24 hours of life and receive an exclusive human milk protein diet (mother's milk supplemented with donor human milk and donor human milk derived fortifier)
排除标准
- •Birth weight > 1000 grams
- •Less than a reasonable expectation for survival for the study duration, enrolled in another clinical study that affects nutritional management
- •Failure to achieve enteral feeds by 14 days of life
- •Major congenital anomalies or clinically significant congenital heart disease, presence of intestinal perforation or Stage 2 NEC prior to tolerating fortified feeds
- •Early transfer to a non-study institution
- •Unable to participate in the study for any reason based on decision of study investigator
研究组 & 干预措施
Control Group (Standard Protein Diet)
Infants will receive a standard feeding regimen which consists of mother's own milk or donor human milk (DHM) with DHM derived fortifier.
Once daily, a 24 hour batch of human milk is prepared for each infant (standard practice). A 2.5 mL sample will be analyzed for calories, protein, fat, and carbohydrates. Based on the amount of protein in the milk, fortification of feeds with donor human milk derived fortifier will be adjusted to reach an average of 3.5 to 3.8 g/kg/day of protein. Data will be recorded for milk analysis, nutrition, and infant growth.
The diet will be continued until approximately 35 to 36 weeks postmenstrual age at which point a DXA scan will be performed.
A serum blood urea nitrogen and creatinine as well as serum calcium, phosphorus, and alkaline phosphatase when the DXA is performed.
Anthropometrics: weekly weight, length, and head circumference by trained research nurse.
干预措施: Standard Protein Diet (Dietary Supplement)
Intervention Group (High Protein Diet)
The intervention group will receive the same standard feeding regimen with the addition of extra milk fortification to give a high protein diet.
Human milk will be prepared and analyzed in the same method as the control group. Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 4.2 to 4.5 g/kg/day.
The diet will be continued until approximately 35 to 36 weeks PMA at which point a DXA scan will be performed.
Infants will have 3 sets of labs. A serum blood urea nitrogen and creatinine as well as serum calcium, phosphorus, and alkaline phosphatase when the DXA is performed.
Anthropometrics: weekly weight, length, and head circumference by trained research nurse.
干预措施: High Protein Diet (Dietary Supplement)
结局指标
主要结局
Linear growth measured using an premature infant length board
时间窗: Weekly until 35-36 postmenstrual age (PMA)
Linear growth will be measured in centimeters (cm) per week. An average weekly linear growth will be calculated for each patient over the study period.These values will be compared to published standards for age.
次要结局
- Body composition measured by dual energy x-ray absorptiometry(Performed at 35-36 weeks postmenstrual age)
研究者
Amy Hair
Assistant Professor of Pediatrics
Baylor College of Medicine