The safety and efficacy of megesterol as part of an outpatient feeding protocol for children with chronic medical conditions

项目摘要/摘要 需要医疗干预的喂养问题发生在3%-10%的儿童中。此外，严重的喂养 患有慢性病的儿童中有40%-70%会出现问题。胃造口术(G-)和胃空肠吻合(G- J)管饲要求可能持续数月或数年，导致慢性口服食物拒绝。作为 胃造瘘管喂养的盛行率增加了，与管理 用管子喂养的孩子，并将孩子从管子喂养过渡到口服喂养。前人关于过渡的研究 儿童从管内喂养到口服喂养表明，大多数方案都是住院或日间治疗，而且许多 孩子们并不成功。 我们的团队开发了一种新的跨学科门诊方案，用于将儿童从输卵管过渡到 口服喂养被称为iKanEat。数据表明，iKanEat对于将管状喂养的儿童过渡到口服饮食是有效的。 IKanEat导致了具有统计学意义和临床意义的口服进食增加。IKanEat是 由几个关键成分组成，包括两种药物--阿米替林和甲酯醇。然而，我们的 最近的研究(HD066629)表明，阿米替林不是该方案的必要组成部分，因为所有 完成方案的儿童在治疗后100%口服卡路里，而不考虑 接受阿米替林或安慰剂治疗。目前的方案是第二个的随机对照试验 药物(甲孕醇)与安慰剂的比较，以确定甲孕醇是否提高了 IKanEat协议。由于所有药物都有副作用，因此我们确定甲孕醇的益处是否与 IKanEat的一部分超过了药物的风险。 目前这项研究的主要目的是进行一项随机对照试验，甲孕醇是唯一的 剩下的药物是iKanEat协议的一部分。第二个目标是评估甲酯醇的安全性。 作为iKanEat协议的一部分。我们之前的工作(以及其他人的工作)表明，6周的课程 甲孕酮可导致某些儿童肾上腺功能不全，因此作为当前方案的一部分，我们将 评估该药4周疗程的安全性。 最后，管饲儿童的父母会遇到多种有关管饲的心理社会压力。 这些问题包括由于潜在的医疗问题对孩子生存的担忧、“失败”的感觉 由于他们不能用口服喂养孩子，增加了管喂养周围的压力，以及 由于管子进食，其他人的支持减少。我们的研究表明，管子里的生活质量很差 喂养儿童，甚至比癌症或烧伤的儿童更多。鉴于这些问题的重要性，第三个问题 本研究的目的是考察从管式喂养过渡到口服喂养对父母压力和父母的影响。 和儿童的生活质量。

Project Summary/Abstract Feeding problems requiring medical intervention occur in 3-10% of children. In addition, severe feeding problems occur in 40-70% of children with chronic medical conditions. Gastrostomy (G-) and gastrojejunal (G- J) tube feeding requirements may persist for months or years resulting in chronic oral food refusal. As the prevalence of gastrostomy tube feeding has increased, so have the challenges associated with managing a child with tube feeding and transitioning a child from tube to oral feeding. Previous research on transitioning children from tube to oral feeding indicates that most programs are inpatient or day treatment, and many children are not successful. Our team developed a novel interdisciplinary outpatient protocol for transitioning children from tube to oral feeding called iKanEat. Data indicate iKanEat is effective for transitioning tube fed children to oral eating. iKanEat results in statistically significant and clinically meaningful increases in oral eating. iKanEat is composed of several key components, including two medications – amitriptyline and megesterol. However, our most recent work (HD066629) suggests that amitriptyline is not a necessary component of the protocol, as all children who completed the protocol consumed 100% of their calories orally at post treatment regardless of receiving amitriptyline or placebo. The current proposal is a randomized controlled trial of the second medication (megesterol) compared to placebo, to determine if megesterol improves the effectiveness of the iKanEat protocol. As all medications have side effects, it is critical we determine if the benefits of megesterol as part of iKanEat outweigh the risks of the medication. The primary aim of the current study is to conduct a randomized controlled trial of megesterol, the only remaining medication that is part of the iKanEat protocol. The second aim is to assess the safety of megesterol as part of the iKanEat protocol. Our previous work (as well as work by others) suggests that a 6 week course of megesterol can lead to adrenal insufficiency in some children, so as part of the current protocol we will assess the safety of a 4 week course of this drug. Finally, parents of tube fed children encounter multiple psychosocial stressors regarding tube feeding. These include concerns about their child’s survival due to their underlying medical issues, feelings of “failure” due to their inability to feed their child orally, increased feelings of stress around the tube feeding, and decreased support from others due to the tube feeding. Our research indicates that quality of life is poor in tube fed children, even more so than children with cancer or burns. Given the significance of these issues, the third aim of the study is to examine the effect of the transition from tube to oral feeding on parent stress and parent and child quality of life.