Enteral Zinc Supplementation in Very Low Birth Weight Infants
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Rate of weight gain
研究概览
简要总结
The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer:
• Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
- Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive ~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks postmenstrual age (PMA) or hospital discharge, whichever comes first.
- The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.
详细描述
This is a prospective, single center, randomized, double blinded, placebo controlled clinical trial. The goal of this clinical trial is to observe for changes in rate of weight gain in the VLBW infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer:
• Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
- Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized using sealed envelopes. The subjects will be randomly selected to one of two groups. The treatment group will receive ~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. Only the pharmacy will know which patient is receiving the Zinc Sulfate and which patient is receiving the placebo. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks PMA or hospital discharge, whichever comes first.
- The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birth weight < 1500 grams
- •Infant is tolerating at least 100 ml/kg/day of enteral feeds
- •At least 25wks PMA.
排除标准
- •Major congenital malformations especially anomaly of the GI tract
- •Major congenital heart disease (i.e.: ductal dependent lesion)
- •Previously diagnosed necrotizing enterocolitis (stage 2 or 3), bowel perforation, or bowel resection
- •Infant who has tolerated ≥100 ml/kg/day prior to admission.
研究组 & 干预措施
Zinc Sulfate
The experimental group will receive ~1 mg/kg/day of elemental enteral Zinc
干预措施: Zinc Sulfate (Drug)
Placebo
The placebo group will receive a similar amount of sterile water in a colored syringe
干预措施: Sterile Water (Other)
结局指标
主要结局
Rate of weight gain
时间窗: at hospital discharge or 36 weeks PMA whichever comes first.
The primary outcome would be the rate of weight gain in grams/kg/day
次要结局
- Length(at hospital discharge of 36 weeks PMA whichever comes first)
- Head Circumference(at hospital discharge of 36 weeks PMA whichever comes first)
- Zinc level(Comparing the initial zinc level to the four week zinc level as well as the zinc level at 36 weeks or discharge whichever comes first)