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 .
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。