NCT02647541已完成不适用
Preoperative Nutritional Intervention and Outcomes Postoperative of Children Submitted to Heart Surgery for Congenital Heart Diseases
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Nutritional status
研究概览
简要总结
The hypothesis of this study is a nutrition preoperatively in infants and children undergoing elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional status, intervention, and that this results in good postoperative results.
详细描述
If this hypothesis is confirmed, there will be subsidies for systematic implementation of nutritional interventions in patients seen in service.
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
- 30 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with congenital heart disease requiring elective surgical correction;
- •Age> 30 days and ≤ 5 years, with the aim of excluding the neonatal period, which are operated children with complex heart defects, and older children, where the time living with the disease damages the myocardium and the pulmonary circulation, leaving only children with fewer serious and, in general, are less subjected to complex surgery diseases.
排除标准
- •Chronic gastrointestinal diseases (defects, malabsorption, celiac disease, inflammatory bowel disease, diabetes mellitus);
- •Patients with other organic defects that may compromise the growth and / or nutritional status;
- •Patients undergoing emergency surgery;
- •Request of parents or guardians at any time;
- •Patients receiving exclusive breastfeeding;
- •Died during the study period;
- •Patients using cardiac pacemaker or other electrical or electronic device that interferes with the reading of the electrical bioimpedance.
研究组 & 干预措施
Nutritional intervention
Experimental
Consultation with a dietitian, including nutritional recommendations and supplementation.
干预措施: Nutritional intervention (Dietary Supplement)
Standard therapy
No Intervention
No specific nutritional recommendations.
结局指标
主要结局
Nutritional status
时间窗: 30 to 45 days prior to surgery
Weight-for-age z-score
次要结局
- Surgical outcomes(on average 15 days after surgery)
研究者
Thatiane Danielly Santos
RD, MSc
University of Sao Paulo
研究点 (1)
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