Abstract：
Children with neurological impairment may have dysphagia and/or gastro-esophageal reflux disease (GERD), which predispose to complications affecting the airways, increasing risk for aspiration-induced acute and chronic lung disease, or secondarily malnutrition, further neurodevelopmental disturbances, stressful interactions with their caregivers and chronic pain. Only multidisciplinary clinical feeding evaluation and empirical trials are applied to provide support to the management of feeding difficulties related to dysphagia or GERD, but no standardized feeding or behavioral measure exists at any age to assess aspiration risk and support the indication to perform a videofluoroscopic swallowing study (VFSS) or a fibre-optic endoscopic examination of swallowing (FEES), in particular in newborns and infants with neurological impairments. Lung ultrasound (LUS) has been proposed as a non-invasive, radiation-free tool for the diagnosis of pulmonary conditions in infants, with high sensitivity and specificity.
A RCT will be conducted in infants aged between 0 and 6 years having, or being at risk for, cerebral palsy, or other neurodevelopmental disease that determines abnormal muscular tone or motor developmental delay assessed by a quantitative scale for infants or if there is the suspicion of GERD or dysphagia based on clinical symptoms. Infants will be allocated in one of 2 groups: 1) LUS-monitored management (LUS-m); 2) Standard care management (SC-m) and after baseline assessment (T0), both groups will undergo an experimental 6-months follow-up. In the first 3 months, infants will be evaluated a minimum of 1 time per month, in-hospital, for a total of 3 LUS-monitored meal evaluations. Primary and secondary endpoint measures will be collected at 3 and 6 months.
This paper describes the study protocol consisting of a RCT with two main objectives: (1) to evaluate the benefits of the use of LUS for monitoring silent and apparent aspiration in the management of dysphagia and its impact on pulmonary illness and growth and (2) to investigate the impact of the LUS management on blood sample and bone metabolism, pain and interaction with caregivers.
Trial registration date 02/05/2020; ClinicalTrials.gov Identifier: NCT04253951 .
A RCT will be conducted in infants aged between 0 and 6 years having, or being at risk for, cerebral palsy, or other neurodevelopmental disease that determines abnormal muscular tone or motor developmental delay assessed by a quantitative scale for infants or if there is the suspicion of GERD or dysphagia based on clinical symptoms. Infants will be allocated in one of 2 groups: 1) LUS-monitored management (LUS-m); 2) Standard care management (SC-m) and after baseline assessment (T0), both groups will undergo an experimental 6-months follow-up. In the first 3 months, infants will be evaluated a minimum of 1 time per month, in-hospital, for a total of 3 LUS-monitored meal evaluations. Primary and secondary endpoint measures will be collected at 3 and 6 months.
This paper describes the study protocol consisting of a RCT with two main objectives: (1) to evaluate the benefits of the use of LUS for monitoring silent and apparent aspiration in the management of dysphagia and its impact on pulmonary illness and growth and (2) to investigate the impact of the LUS management on blood sample and bone metabolism, pain and interaction with caregivers.
Trial registration date 02/05/2020; ClinicalTrials.gov Identifier: NCT04253951 .
摘要：
患有神经功能缺损的儿童可能有吞咽困难和/或胃食管反流病（GERD），容易导致影响气道的并发症，增加吸入性急性和慢性肺病的风险，或者其次是营养不良，进一步的神经发育障碍，与护理人员的紧张互动和慢性疼痛。仅应用多学科临床喂养评估和经验试验来为与吞咽困难或GERD相关的喂养困难的管理提供支持。但是在任何年龄都没有标准化的喂养或行为措施来评估误吸风险，并支持进行视频透视吞咽研究（VFSS）或光纤内窥镜吞咽检查（FEES）的指征，特别是新生儿和有神经损伤的婴儿。肺超声(LUS)已被提出作为一种非侵入性,用于诊断婴儿肺部疾病的无辐射工具，具有较高的敏感性和特异性。
RCT将在0至6岁的婴儿中进行，或者有风险，脑瘫,或其他神经发育疾病，通过婴儿定量量表评估确定异常的肌张力或运动发育迟缓，或者根据临床症状怀疑GERD或吞咽困难。婴儿将被分为2组：1）LUS监测管理（LUS-m）;2）标准护理管理（SC-m）和基线评估后（T0），两组均接受为期6个月的实验性随访.前三个月,婴儿将每月至少接受1次评估，在医院,总共进行了3次LUS监测的膳食评估。主要和次要终点测量将在3个月和6个月收集。
本文描述了由RCT组成的研究方案，其主要目的有两个：（1）评估使用LUS监测吞咽困难的沉默和明显吸入的益处及其对肺部疾病和生长的影响；（2）调查LUS管理对血液样本和骨代谢的影响，疼痛和与护理人员的互动。
试验注册日期02/05/2020；ClinicalTrials.gov标识符：NCT04253951。
RCT将在0至6岁的婴儿中进行，或者有风险，脑瘫,或其他神经发育疾病，通过婴儿定量量表评估确定异常的肌张力或运动发育迟缓，或者根据临床症状怀疑GERD或吞咽困难。婴儿将被分为2组：1）LUS监测管理（LUS-m）;2）标准护理管理（SC-m）和基线评估后（T0），两组均接受为期6个月的实验性随访.前三个月,婴儿将每月至少接受1次评估，在医院,总共进行了3次LUS监测的膳食评估。主要和次要终点测量将在3个月和6个月收集。
本文描述了由RCT组成的研究方案，其主要目的有两个：（1）评估使用LUS监测吞咽困难的沉默和明显吸入的益处及其对肺部疾病和生长的影响；（2）调查LUS管理对血液样本和骨代谢的影响，疼痛和与护理人员的互动。
试验注册日期02/05/2020；ClinicalTrials.gov标识符：NCT04253951。
