Individualizing and Optimizing Nutrition to Prevent Metabolic Syndrome and To Improve Neurodevelopment in Preterm and Small for Gestational Age Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Linear Growth Velocity
研究概览
简要总结
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate and serum analyses).
The first specific aim will determine whether individualized and optimized nutrition during hospitalization results in improved growth in the neonatal intensive care unit (NICU) in extremely low gestational age (GA) neonates (ELGANs, <29 weeks) and in small for GA (SGA, birth weight <10th percentile for GA) preterm infants compared with optimized nutrition.
The second specific aim will determine whether individualized and optimized nutrition in the NICU improves neurodevelopmental outcomes (acquisition of development milestones) and reduces the risk of disproportionate growth (i.e., excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.
详细描述
Hypotheses:
- Primary hypothesis: In preterm infants (GA <29 weeks or GA <35 weeks and SGA) individualized and optimized nutrition will increase velocity of growth (weight gain velocity by 2 g x kg-1 x day-1 and length velocity by 0.2 cm per week) from birth to 36 weeks of postmenstrual age (GA plus postnatal age) or discharge (whichever comes first) in comparison with optimized nutrition.
- Secondary hypotheses: Individualized and optimized nutrition will improve neurodevelopmental outcome and reduce the risk of disproportionate growth (excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.
Study design:
Double-blinded randomized controlled trial (RCT): After consent, 150 neonates will be randomized to one of two groups.
Study intervention: Patients will be randomized to either:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Only the statistician and the formula technicians know the patients' allocation.
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants <29 weeks GA and SGA infants <35 weeks GA born at Parkland Health and Hospital System
- •Maternal plan to breastfeed or to use milk from the donor milk bank
- •From birth to 1 week of life
排除标准
- •Patients on comfort care only
- •Patients with major congenital abnormalities
- •Patients who are too unstable for the first 7 days to have an accurate length measurement
结局指标
主要结局
Linear Growth Velocity
时间窗: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Increase in body length per week from birth to 36 weeks postmenstrual age or discharge
Growth Velocity
时间窗: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Rate of weight gain \[g x kg-1 x day-1\] and length velocity \[cm x week-1\]
次要结局
- Hypertension or High Systolic Blood Pressure(at 33-48 months adjusted age)
- Rate of Weight Gain(36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first))
- Disproportionate Growth (Increased Fat Mass): BMI >90th Centile(36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first))
- Leptin(33-48 months adjusted age)
- Renal Function(33-48 months adjusted age)
- Comparison of Weight With Expected Value for Age and Gender(36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first))
- Comparison of Length With Expected Value for Age and Gender(36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first))
- Rate of Linear Growth(36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first))
- Comparison of Rate of Head Growth With Expected Value for Age and Gender(36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first))
- Blood Pressure(36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first))
- Body Composition(at 1 year of age and 3 years of age)
- Neurodevelopment(18-41 months adjusted age (postnatal age corrected for prematurity) 18-41 months adjusted age (postnatal age corrected for prematurity) 18-41 months corrected age 18-41 months)
- Comparison of Head Size With Expected Value for Age and Gender(36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first))
研究者
Luc P. Brion, MD
Professor of Pediatrics
University of Texas Southwestern Medical Center