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临床试验/NCT05826769
NCT05826769招募中不适用

To Assess the Efficacy of Early Administration of Energy Enriched and Protein Enriched Formula in Post Cardiac Repair Infants: a Randomized Controlled Trial, Comparative Study

King Faisal Specialist Hospital & Research Centre, Jeddah1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
after admission in ICU, will measure the Tolerability

研究概览

简要总结

Congenital heart disease (CHD) is a public health problem, A substantial percentage of infants and toddlers with CHD undergo cardiopulmonary bypass surgery. Undernutrition affects up to 90% of these patients, and it's contributed to worse surgical and neurological outcomes. Infants with CHD are typically delivered at full term with a normal birth weight. However, as time passes, their development may become stunted. There are no negotiated guidelines for nutritional monitoring and intervention in this age bracket of infants. Through the use of Energy Enriched and Protein Enriched nutrition formula during the postoperative phase, this has shown to be well tolerated and support in delivering higher nutrition intakes within the first days after surgery. The objective of this research is to assess the long term outcome of patients who have had energy- and protein-rich nutrition formulas post cardiac surgery. An open, 2-arm, randomized controlled trials will be conducted to assess the efficacy of early administration of energy enriched and protein enriched formula in post cardiac repair infants. The expected primary outcome is that intervention group will have good tolerance to feeding and the secondary outcome is the significant weight gain rate (weight velocity) in comparing to control groups

详细描述

Due to a high incidence of 9/1000 live births, congenital heart disease (CHD) is a public health problem, A substantial percentage of infants and toddlers with CHD undergo cardiopulmonary bypass surgery. Undernutrition affects up to 90% of these patients, and it's contributed to worse surgical and neurological outcomes. Infants with CHD are typically delivered at full term with a normal birth weight. However, as time passes, their development may become stunted. There are no negotiated guidelines for nutritional monitoring and intervention in this age bracket of infants. Through the use of Energy Enriched and Protein Enriched nutrition formula during the postoperative phase, this has shown to be well tolerated and support in delivering higher nutrition intakes within the first days after surgery. Numerous clinical trials have been conducted (Zhang H et al., 2018; Scheeffer. et al., 2019) and were designed to explore the effects of early introduction of Energy Enriched and Protein Enriched formula (EP) to infants with CHD. The research found that feeding EP is correlated with improved weight gain and nutritional status, and also a decrease in Hospital Length Of Stay (HLOS) as well as antibiotic use, but this also causes increased feeding discomfort. The signs of feeding discomfort, on the other hand, were improved by medication and had little effect on feeding progress.

The objective of this research is to assess the long term outcome of patients who have had energy- and protein-rich nutrition formulas post cardiac surgery.

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

盲法说明

According to national regulations, distribution of infant formula inside the hospital without a proper label is not allowed; therefore, subjects can not be blinded in this study.

入排标准

年龄范围
4 Weeks 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • infants born at term, age between 4 weeks and 12 months
  • post congenital heart surgery (RACHS score 2)

排除标准

  • syndromic patients
  • if patient is on parenteral nutrition (PN)
  • combined inherited metabolic or chromosomal diseases
  • liver and kidney dysfunction before enrollment (index >2 times the upper limit of normal)
  • upper GI activity, vomiting, diarrhea, bloating, and other symptoms before enrollment
  • breastfeeding patients.
  • cow's milk allergy

结局指标

主要结局

after admission in ICU, will measure the Tolerability

时间窗: 5 days

Gastric tolerance

次要结局

  • Weight gain rate(90 days)

研究者

发起方
King Faisal Specialist Hospital & Research Centre, Jeddah
申办方类型
Other
责任方
Sponsor

研究点 (1)

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