Beginning With a Healthy Start: A Randomized Controlled Trial of Informatics-Enhanced Newborn Weight Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,682
- 试验地点
- 2
- 主要终点
- Concordance with feeding recommendation during the birth hospitalization
研究概览
简要总结
Weight loss is normal for healthy newborns in the first few days, especially for those exclusively breastfed, who may have low enteral intake for several days. Although most newborns tolerate this early period of weight loss well, those with pronounced weight loss become at increased risk of feeding problems and hyperbilirubinemia, which are the two most common causes of neonatal readmission. To facilitate the assessment of risk for an individual newborn, the Newborn Weight Tool (NEWT) has been developed to categorize each infant's weight loss according to population norms, so that formula can be administered when weight loss is pronounced and avoided when weight loss is normal. The Healthy Start study will be a randomized, controlled trial testing whether displaying NEWT to clinicians providing newborn care can improve neonatal health outcomes including formula use, weight loss and readmission. Newborns will be randomly assigned either to display weight with NEWT weight categorization to their providers in the electronic health record (EHR) or to usual care (weight displayed without NEWT categorization).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Hours 至 96 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Assignment to a bed assignment on the well newborn service at the time of the first weight measured subsequent to birth weight and at >6 hours and <=96 hours of age
排除标准
- 未提供
结局指标
主要结局
Concordance with feeding recommendation during the birth hospitalization
时间窗: 0-96 hours
Feeding is defined as concordant with feeding recommendation if any of the following occur: 1) for newborns who do not have documented weight loss \>=75th NEWT centile, formula is not used; 2) for newborns with only one weight documented that is more pronounced than the 75th centile, no formula is used prior to the weight documented at more pronounced than the 75th centile; 3) for newborns who have two weights documented more pronounced than the 75th centile, formula is used.
次要结局
- Proportion exclusively breastfed(0-96 hours)
- Excess neonatal outpatient utilization(0-30 days)
- Non-preventive outpatient utilization(0-30 days)
- Outpatient utilization(0-30 days)
- Proportion readmitted to the hospital(0-30 days)
- Length of hospital stay(0-96 hours)
- Proportion with donor milk use(0-96 hours)
- Ratio of indicated formula use to non-indicated formula use during the birth hospitalization(0-30 days)