Is Milk Associated with Glycemia in the NICU (MAGIC) a Study in the NICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Insulin concentration in prepared feeds
研究概览
简要总结
The purpose of this study is to determine if concentrations of hormones in prepared human milk (HM) feeds are associated with metabolic disturbances in the recipient premature infant. To do so, prospectively 100 infants receiving HM-derived fortifiers as part of clinical care will be studied, saving aliquots of daily prepared feeds until any fortification ceases.
详细描述
The purpose of this study is to determine if concentrations of these hormones in prepared HM feeds are associated with metabolic disturbances in the recipient infant. A prospectively study 100 infants receiving HM-derived fortifiers as part of clinical care, saving aliquots of daily prepared feeds until any fortification ceases. Insulin and PTHrP will be compared in feeds from matched days when metabolic disturbances were documented vs not; each infant serving as a control.
Hypothesis 1 Feed dose of insulin and PTHrP will be higher from days when hypoglycemia and hypercalcemia are observed, respectively, vs control days when metabolic disturbances are not observed.
Hypothesis 2: Over time, daily feed dose of insulin will correlate with average daily blood glucose in infants receiving HM products.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants eligible to receive human milk (HM)-derived fortifiers. To qualify for these fortifiers, infants must be born <30 weeks gestation and/or weigh <1250g at birth. Enteral or oral feeding modes both qualify for participation. Additional supplementation to feeds beyond HM-derived fortifier (such as medium-chain triglycerides) is acceptable.
- •Infants initially on intravenous nutrition will still be eligible for consent. Feed sample collections from these infants will commence once they advance to consume HM-based feeds once HM-derived fortifier is prescribed.
排除标准
- •Infants diagnosed with congenital disorders that impact glucose or calcium metabolism will be excluded.
- •Infants with conditions necessitating specialized diets (ex: chylothorax) will also be excluded.
- •Non-English speaking subjects will be excluded as the team of study personnel includes those that speak English only.
结局指标
主要结局
Insulin concentration in prepared feeds
时间窗: 3 months
We will measure final insulin concentrations in enteral feed preparations that contain some portion of human milk.
Parathyroid hormone related protein (PTHrP) concentration in prepared feeds
时间窗: 3 months
We will measure final PTHrP concentrations in enteral feed preparations that contain some portion of human milk.
次要结局
未报告次要终点
研究者
Bridget Young
Assistant Professor
University of Rochester