Health, Economic Analysis and Clinical Aspects of a Pediatric Cohort With Severe Motor and Intellectual Disabilities in Enteral Nutrition With Dedicated Formula. A Case-control Retrospective Observational Study for the Management of Gastroesophageal Reflux: the Role of Fundoplication According to Nissen.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- To identify the annual economic impact related to the treatment of patients undergoing NF surgery and the costs related to patients undergoing enteral nutrition, analyzing type of formula offered.
研究概览
简要总结
Nutritional difficulties are common in children with neurodisabilities and can be associated with malnutrition and gastrointestinal diseases, such as gastro-esophageal reflux disease (GERD) and constipation. Neurological disorders can be divided into two main categories: progressive (neurodegenerative, mitochondrial disease) and non-progressive (cerebral palsy) neurodisabilities; nature of the disorders can impair on the nutritional status of these children. In 2017, ESGHAN published guidelines with specific nutritional claims. Approximately 46%-90% of children with neurodisabilities suffer from malnutrition and an enteral feeding is necessary to reach the nutritional requirements. In addition, a relevant issue for these children is GERD, reaching up to 70% prevalence. The treatment of GERD could be based on pharmacological therapy (protonic pomp inhibitor, PPI), on nutritional treatment (changing type of formula) or on surgical treatment (Nissen Fundoplication). European guidelines for GERD recommend PPI as the first line, with fundoplication being considered in cases of failure of optimized medical therapy. Enteral feeding can be considered in order to avoid malnutrition and is justified when other efforts to increase nutritional intake. Enteral feeding can be provided by nasal tube at the beginning, but a gastrostomy feeding tube would be preferred for a long-term nutrition (greater than six weeks). A jejunal tube can be introduced through the gastrostomy; jejunal feeding is appropriate in patients with recurrent vomiting and/or tube feeding-related aspiration, severe gastroesophageal reflux, and gastroparesis. Different types of formulas can be used for enteral nutrition and can be offered by nasal tube, percutaneous endoscopic gastrostomy (PEG) or percutaneous endoscopic jejunostomy (PEJ). Whey-based formulas have been shown to empty from the stomach more rapidly than casein-based formulas, which may be helpful for patients presenting with delayed gastric emptying. Use of peptide-based, 100% whey protein formulas are associated with improved feeding tolerance, increased consistency in meeting nutritional needs, and a reduction in gastrointestinal issues associated with vomiting and aspiration of feeds. For these reasons, the aim of this study is to retrospectively evaluate the role of different formulas against Nissen fundoplication, regarding tolerance, utility, applicability and safeness of these products, by performing a cost analysis.
详细描述
Nutritional difficulties are common in children with severe motor and intellectual disabilities (SMID) and can be associated with malnutrition, growth difficulties, micronutrient deficiencies, osteopenia and nutritional comorbidities. In children with SMID, neurological disorders can be divided into two main categories: progressive and non-progressive neurodisabilities. Progressive neurological disorders feature a progressive decline of functioning, which can occur over many years and decades, or more rapidly over weeks and months. Such disorders include mitochondrial disorders, myopathies, disorders only involving the spinal cord, or neuromuscular disorders and are likely to have a lifelong course. On the other hand, non-progressive neurological disorders apparently do not feature a progression of disease, as seen in the most common condition, infantile cerebral palsy (ICP).
Both progressive and non-progressive neurological disorders feature nutritional difficulties following involvement of the central nervous system or neuromuscular disorders. In patients with both conditions, oral motor dysfunction (involving tongue, chin or the whole mouth) results in the development of feeding problems.
Moreover, gastrointestinal disturbances in these children reflect the interplay between the central nervous system and the enteric nervous system.
In 2017, specific guidelines for the nutritional management of children with neurological disease were published by the ESPGHAN. These guidelines mention the following five warning signs ("red flags") for the identification of nutritional issues in children with neurological impairment: (1) physical signs of undernutrition (decubitus skin problems, poor peripheral circulation), (2) weight for age Z-score <-2, (3) triceps skinfold thickness <10th centile forage and sex, (4) mid-upper arm fat or muscle area <10thcentile and (5) faltering weight and/or failure to thrive.
Guidelines also suggest not to limit nutritional status assessment based on weight and height alone, but to also perform evaluation of knee height or tibial length when height cannot be measured, of fat mass by skinfold thickness, of BMD by DXA scans, and of micronutrient status.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 29 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with severe motor and intellectual disabilities (SMID);
- •Pediatric patients ( 29 days; <18 years);
- •Subjects whose enteral nutrition through a nasogastric tube or endoscopic gastrostomy; percutaneous (PEG) involves the administration of a special formula based on whey protein or a formula based on caseinates;
- •Subjects undergoing or not NF surgery.
排除标准
- •Patients less than 24 months of follow-up at the closing of the database;
- •Patients with less than 12 months of observation.
结局指标
主要结局
To identify the annual economic impact related to the treatment of patients undergoing NF surgery and the costs related to patients undergoing enteral nutrition, analyzing type of formula offered.
时间窗: 11 years
Annual economic impact expressed in Euro, calculated by Health Direction based on specific invoice (SDO) and specific calculator (provided by Italy Ministry of Health); length of hospitalization expressed in days
次要结局
- To evaluate whether the need for NF is postponed or reduced in the patient population fed with enteral formulas based on whey proteins(11 years)
- Describe and quantify the occurrence of GI disorders associated with different types of enteral nutritional formulas (whey protein vs caseinates)(11 years)