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

甲地孕醇作为慢性病儿童门诊喂养方案的一部分的安全性和有效性

• 批准号: 10642653
• 负责人: Ann M Davis
• 金额: $ 42.44万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-13 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10642653
• 关键词: Adrenal Cortex Hormones; Adrenal gland hypofunction; Aftercare; Age; Amitriptyline; Birth; Burn injury; Calories; Child; Childhood; Chronic; Classification; Clinical; Consumption; Data; Diagnosis; Eating; Effectiveness; Enteral Feeding; Failure; Family; Feeling; Food; Gastrostomy; Gender; Health; Hospitalization; Hydrocortisone; Infant; Inpatients; Intensive Care; Intervention; Learning; Malignant Childhood Neoplasm; Medical; Normal Range; Oral; Oral cavity; Outcome; Outpatients; Pain; Parents; Pharmaceutical Preparations; Placebos; Population; Premature Infant; Prevalence; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Research; Risk; Safety; Stress; Time; Toddler; Tube; Work; effective therapy; effectiveness evaluation; efficacy evaluation; feeding; improved; medical complication; neonate; novel; placebo group; prevent; programs; psychosocial stressors; safety assessment; side effect; therapy design; treatment duration; treatment program

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.

项目总结/摘要 3-10%的儿童出现需要医疗干预的喂养问题。此外，严重的喂养 40-70%患有慢性疾病的儿童会出现问题。胃造口术（G-）和胃空肠（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。为 胃造口管饲的流行率增加了，与管理胃造口相关的挑战也增加了。 管饲儿童和从管饲儿童过渡到口服喂养。关于转型的前期研究 从管饲到口服喂养的儿童表明，大多数方案是住院或日间治疗，许多 孩子们不成功。 我们的团队开发了一种新的跨学科门诊协议，用于将儿童从试管婴儿过渡到 名为iKanEat。数据表明，iKanEat对于将管饲儿童转变为口服饮食是有效的。 iKanEat导致口腔进食的统计学显著和临床意义的增加。iKanEat是 由几种关键成分组成，包括两种药物-阿米替林和甲孕酮。但我们的 最近的研究（HD 066629）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口服100%的卡路里， 接受阿米替林或安慰剂。目前的建议是第二个随机对照试验 与安慰剂相比，药物（甲孕酮），以确定是否甲孕酮改善的有效性 iKanEat协议。由于所有的药物都有副作用，因此我们必须确定甲孕酮的益处是否 iKanEat的一部分超过了药物的风险。 目前研究的主要目的是进行一项随机对照试验， iKanEat协议中的剩余药物。第二个目的是评估甲孕酮的安全性 作为iKanEat协议的一部分我们以前的工作（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4周疗程的安全性。 最后，管饲儿童的父母遇到多种心理社会压力有关管饲。 这些包括由于潜在的医疗问题而对孩子生存的担忧，“失败”的感觉， 由于他们无法用口喂养孩子，增加了管饲周围的压力感， 由于管饲，其他人的支持减少。我们的研究表明，生活质量是穷人在管 喂养的孩子，甚至比患癌症或烧伤的孩子还要多。鉴于这些问题的重要性，第三个问题 本研究的目的是检验从管饲到口服喂养的转变对父母压力和父母的影响。 孩子的生活质量。

项目成果

iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol.

• DOI: 10.1186/s13063-021-05131-w
• 发表时间: 2021-02-27
• 期刊: Trials
• 影响因子: 2.5
• 作者: Edwards S;Hyman PE;Mousa H;Bruce A;Cocjin J;Dean K;Fleming K;Romine RS;Davis AM
• 通讯作者: Davis AM