Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Growth rate for head circumference (cm/week) from birth to 36+0 weeks CGA
研究概览
简要总结
Multiple factors contribute to growth failure in infants with BPD, including poor nutrient stores, inadequate intake, increased losses, and increased needs. Furthermore, compared to infants without BPD, those with BPD have increased resting metabolic rates and energy expenditure. Growth deficits manifest as lower weight, length, and head circumference, as well as changes in body composition. These deficits precede the development of BPD and persist post-discharge. While similar rates of growth are observed in very low birth weight infants with and without BPD once receiving equal calories, catch up growth does not occur in the BPD group. Thus, early growth deficits remained uncompensated.
After iron, zinc is the most metabolically active trace element in the human body. It has a critical role in growth, through its actions on growth hormone, IGF-1, IGFBP-3, and bone metabolism. Prematurity is a risk factor for zinc deficiency, as 60% of zinc accretion occurs in the third trimester. Impaired intake and absorption or excess excretion can further increase this risk. Finally, periods of rapid growth, as seen in preterm infants, increase the need for zinc.
Biochemically, zinc deficiency is defined by a serum zinc level less than 55mcg/dl. However, while zinc depletion is associated with deficiency, the opposite may not be true. For example, in starving patients, clinical symptoms of zinc deficiency occur during re-feeding, suggesting overall requirements are related to needs, regardless of overall zinc status. This may be the case in preterm infants, who may have a subclinical deficiency despite serum zinc level. Thus, zinc deficiency should be considered in infants with poor growth despite receiving adequate protein and calories.
The objective of this study is to determine whether enteral zinc supplementation leads to improved growth in infants at risk for bronchopulmonary dysplasia (BPD). The investigator's hypothesis is that enteral zinc supplementation in very preterm infants at high risk for BPD will significantly improve growth compared to standard of care.
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
- None
入排标准
- 年龄范围
- 14 Days 至 28 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •23 0/7 to 29 6/7 weeks GA
- •Birth weight 501 to 1000g, inclusive
- •14 to 28 days of life, inclusive
- •14 day BPD risk score ≥ 50% for death or moderate-severe BPD, calculated using the algorithm on the Neonatal Research Network website (https://neonatal.rti.org/index.cfm?fuseaction=BPDCalculator.start).-
排除标准
- •Major congenital and/or chromosomal anomalies
- •Inability to reach 80ml/kg/day enteral feeds by 28 days of life
结局指标
主要结局
Growth rate for head circumference (cm/week) from birth to 36+0 weeks CGA
时间窗: Birth to 36+0 weeks corrected gestational age
Average weekly changes in head circumference from birth to 36+0 weeks CGA will be calculated and compared between both arms.
Growth rate for length (cm/week) from birth to 40+0 weeks CGA
时间窗: Birth to 40+0 weeks corrected gestational age
Average weekly changes in length from birth to 40+0 weeks (or discharge, whichever happens first) CGA will be calculated and compared between both arms.
Growth rate for weight (g/kg/day) from birth to 40+0 weeks CGA
时间窗: Birth to 40+0 weeks corrected gestational age
Average daily changes in weight from birth to 40+0 CGA (or discharge, whichever happens first) will be calculated and compared between both arms.
Growth rate for head circumference (cm/week) from birth to 40+0 weeks CGA
时间窗: Birth to 40+0 weeks corrected gestational age
Average weekly changes in head circumference from birth to 40+0 weeks CGA (or discharge, whichever happens first) will be calculated and compared between both arms.
Growth rate for weight (g/kg/day) from birth to 36+0 weeks corrected gestational age (CGA)
时间窗: Birth to 36+0 weeks corrected gestational age
Average daily changes in weight from birth to 36+0 CGA will be calculated and compared between both arms.
Growth rate for length (cm/week) from birth to 36+0 weeks CGA
时间窗: Birth to 36+0 weeks corrected gestational age
Average weekly changes in length from birth to 36+0 weeks CGA will be calculated and compared between both arms.
次要结局
- Measure rates of severe BPD diagnoses at 36+0 weeks CGA(36+0 weeks corrected gestational age)
- Measure changes in serum insulin-like growth factor binding protein 3 (IGFBP-3)(Study day 0 to 36 weeks corrected gestational age)
- Measure changes in bone quality per tibial ultrasound(Study day 0 to 36 weeks corrected gestational age)
- Measure changes in serum insulin-like growth factor 1 (IGF-1)(Study day 0 to 36 weeks corrected gestational age)
研究者
Bradley Yoder
Principal Investigator
University of Utah
