Safety of Manganese Restriction in Neonatal Parenteral Nutrition
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Whole Blood Manganese
研究概览
简要总结
Participants will be <= 32 weeks gestational age (GA) neonates randomized to parenteral nutrition (PN) prepared with standard dose trace elements or to PN prepared with standard trace elements minus manganese.
详细描述
Very preterm neonates <= 32+6 weeks GA receiving PN will be randomized to receive their PN prepared with standard trace elements containing 5 mcg/kg/day of manganese, or to PN prepared with no added manganese. Randomization assignment will be double masked. All participants will have whole blood manganese measurements at baseline, at 2 weeks of postnatal age, and at 8 weeks postnatal age. Because manganese is present as a contaminant in many of the ingredients used to prepare neonatal PN, this study hypothesizes that neonates randomized to no added manganese in their PN will maintain whole blood manganese concentrations above the lower limit of normal.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn admissions to the SHARP Mary Birch Hospital for Women and Newborns neonatal intensive care unit.
- •Less than or equal to 32+6 weeks gestational age.
- •Initiated on parenteral nutrition as decided by their attending neonatologist.
排除标准
- •Continuous exposure to routine care PN containing standard trace element for ≥ 4 hours.
- •Congenital liver disease.
- •Moribund status or imminent death.
- •Any condition that in the judgment of the investigator or attending physician provider precludes participation because it could affect subject safety.
- •Lack or refusal of informed consent
结局指标
主要结局
Whole Blood Manganese
时间窗: 8 weeks of age
concentration of manganese in blood
次要结局
未报告次要终点
研究者
Jason Sauberan, PharmD
Clinical Research Pharmacist
Sharp HealthCare