Evaluation of the Influence of a Pharmacist-led Patient-Centered Medication Therapy Management on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- reticulocyte hemoglobin equivalent (Ret-He, pg)
研究概览
简要总结
This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.
详细描述
This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. As a result, the Committee on Nutrition of the American Academy of Pediatrics (AAP) recommends daily oral iron supplementation, of at least 2-4 mg/kg/day from 2 weeks of age, to prevent iron deficiency in extremely premature infants. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 26 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NICU inpatients between 26 and 32 weeks of gestation Infants older than two week of age and Iron dosing will be adjusted for weight at weekly intervals to maintain dosing at 4mg/kg/day.
- •Parental permission obtained prior to start of study
排除标准
- •In extremis during consent window (as judged by primary attending provider) Known or suspected genetic disorder Small for gestational age (birth weight below the 10th percentile for gestational age) Unable to return for follow-up evaluation at 6 months of age
结局指标
主要结局
reticulocyte hemoglobin equivalent (Ret-He, pg)
时间窗: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Iron insufficiency will be determined by Ret-He less than 27.2 pg
reticulocyte count (%)
时间窗: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Iron insufficiency will be determined by reticulocyte count less than 2%
ferritin level
时间窗: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Iron insufficiency will be determined by ferritin level less than 70 ng/mL
hemoglobin level
时间窗: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Iron insufficiency will be determined by hemoglobin level less than 8 g/dL
次要结局
未报告次要终点
研究者
Xu Renjie
Department of Clinical pharmacy
Shaoxing Maternity and Child Health Care Hospital