Corrected Weight to the 10th Percentile vs. Actual Birth Weight for the Calculation of Nutritional Needs of Small for Gestational Age Neonates Fed on Parenteral Nutrition: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Body weight change
研究概览
简要总结
This randomized controlled trial included 100 preterm and small for gestational age neonates. The study aimed to determine the optimal approach for estimating nutritional needs in parenteral nutrition (PN) with the assistance of a specialized clinical decision support system (CDSS). More specifically, nutrient estimations based on the neonates' actual birth weight were compared to those calculated using the weight corresponding to the 10th percentile of the growth curve. The effect on growth outcomes over the PN course was investigated.
详细描述
Background: Parenteral nutrition (PN) plays a crucial role in providing nutritional support to premature and small for gestational age neonates.
Aim: In this randomized controlled study, we evaluated PN administration in preterm and small for gestational age neonates using the corrected weight estimated at the 10th percentile of the growth curve, as guided by a clinical decision support system (CDSS).
Methods: A total of 100 preterm neonates were randomly assigned to either the Control group (n = 50) or the Intervention group (n = 50). Both groups received PN support using a specialized CDSS. In the Control group, the CDSS calculated the PN regimen based on the actual birth weight, whereas in the Intervention group, calculations were based on the corrected weight corresponding to the 10th percentile. Growth indicators (i.e., body weight, length, and head circumference) were measured at baseline and at the time of exclusive enteral feeding initiation. Blood samples were obtained at the last day of PN, after PN was ceased for 4 h and before oral feeding initiation. Electrolytes (sodium, potassium, calcium) and albumin concentrations, as well as red blood cells, white blood cells, haemoglobin and haematocrit were measured at the last day of PN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Care Provider)
盲法说明
The care providers who administered the parenteral (PN) solutions to the neonates were blinded to the identity of the PN solution.
入排标准
- 年龄范围
- 1 Day 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •preterm neonates hospitalized in NICU and meeting the criteria for small for gestational age infants, i.e., neonates with birth weight under the 10th percentile,
- •preterm neonates receiving exclusive parenteral nutrition, and
- •parents' written consent for study participation.
排除标准
- •term birth newborns or newborns not fullfilling the criteria of small for gestational age infants,
- •newborns with primary liver/bile duct disease,
- •newborns receiving enteral nutrition, and/or
- •neonates whose parents did not give a written consent to participate in the study
研究组 & 干预措施
Nutrient estimation based on the actual weight (Control group)
In the Control group, the clinical decision support system was used to determine parenteral nutriton requirements.
干预措施: Control group (Dietary Supplement)
Nutrient estimations based on the corrected weight (Intervention group)
In the Intervention group, the clinical decision support system was used to determine parenteral nutrition requirements.
干预措施: Intervention Group (Dietary Supplement)
结局指标
主要结局
Body weight change
时间窗: From birth day (day 1) till the last day of parenteral nutrition support (study endpoint). Each neonate had different PN duration according to their clinical status (average 12 days).
The primary outcome is to detect a statistical significant difference in body weight increase between the control and the intrevention group at the last day of parenteral nutrition support (study endpoint).
次要结局
未报告次要终点
研究者
Panos Papandreou
Head Pharmacologist
Iaso Maternity Hospital, Athens, Greece