Clinical Outcomes of the Use of Ready-to-Use Parenteral Nutrition in Very Low Birth Weight Newborns in a Fourth-level Neonatal Intensive Care Unit in Cali, Colombia, March 2017-March 2023
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Growth velocity - Height
研究概览
简要总结
The proposed study aims to assess the clinical outcomes of using ready-to-use parenteral nutrition, specifically Numeta G13E, compared to individualized parenteral nutrition in neonates with very low birth weight. Conducted in a level 4 neonatal intensive care unit from March 2017 to March 2023, the study focuses on growth parameters (weight, head circumference, height), growth velocity, and the incidence of complications. The retrospective open-cohort observational design involves a sample of 284 infants, 142 in each group, considering a 95% confidence level and 80% power. The study addresses the need for a local evaluation of the efficacy of ready-to-use parenteral nutrition in this vulnerable population.
详细描述
Introduction:
Parenteral nutrition enhances nutrition in very low birth weight newborns (<1500 g) who, due to gastrointestinal immaturity, experience delays in obtaining adequate nutrients enterally. Parenteral nutrition (PN) promotes better growth in all anthropometric variables in this population.
However, complications associated with its use have been documented. A commercial method developed to reduce these complications is ready-to-use parenteral nutrition, a three-chamber bag providing a complete mix of nutrients, offering immediate access, quicker initiation of nutrition, and prescription homogenization. These factors aim to achieve better metabolic stability, improved nutritional intake, and weight, height, and head circumference gain.
This study aims to evaluate outcomes with the initiation of ready-to-use parenteral nutrition.
Theoretical Framework:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns admitted to the neonatal intensive care unit between March 2017 and March 2023
- •Requirement for Parenteral Nutrition.
- •Birth weight less than 1500 grams (very low birth weight).
排除标准
- •Patients transferred from another hospital with more than 24 hours of life.
- •Incomplete follow-up (until 36 weeks corrected age or discharge).
- •Major congenital anomalies.
结局指标
主要结局
Growth velocity - Height
时间窗: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Length in centimeters gained per unit of time
Length
时间窗: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Length in centimeters
Weight
时间窗: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Weight in grams
Head circumference
时间窗: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Circumference in centimeters
Growth velocity - Weight
时间窗: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Weight in grams gained per unit of time
Growth velocity - Head circumference
时间窗: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Head Circumference in centimeters gained per unit of time
次要结局
- Number of Participants with Hyperglycemia(Up to 14 days)
- Number of Participants with Bloodstream infections(36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.)
- Number of Participants with Electrolyte disorders(Up to 14 days)
研究者
Adriana Ballesteros
Neonatologist
Fundacion Clinica Valle del Lili