Lung Ultrasound for Early Detection of Silent and Apparent aspiratioN in Infants and Young CHildren With Cerebral Palsy and Other Developmental Disabilities: a New Fast, Safe, Cost-effective Infant-friendly Imaging Tool to Easily Monitor Feeding , Improve Outcomes and Reduce Morbidities (LUNCH)
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- growth
研究概览
简要总结
The aim is to test the effectiveness of lung ultrasound (LUS) in the dynamic assessment of aspiration related to abnormal swallowing in infants and young children with neurological impairment (cerebral palsy/developmental disabilities). Neither standardized measure is available, nor protocols for invasive fibre-optic endoscopic examination of swallowing (FEES) and x-Ray videofluoroscopic swallowing study (VFSS) to be used in such population. LUS offers several advantages: time saving for aspiration diagnosis; safeness (neither invasiveness nor radiation); repeatability with different meal consistencies or to monitor interventions efficacy; cost-effectiveness; savings of x-Ray exposition (compared to VFSS). All these advantages may lead infants to improve clinical behavioural and neurological outcomes and reduce stressful interactions with caregivers, and to reduce morbidities and hospitalization costs for respiratory and non-respiratory complications related to swallowing disorders.
详细描述
The dynamic use of LUS for monitoring feeding related aspiration can be effective in detecting meal-related pulmonary abnormalities in neurologically impaired infants and that LUS-management will improve medical/neurological/behavioural status, and reduce chronic pain/discomfort and stress for caregivers. LUS effectiveness is expected to reduce the need for x-Ray, invasive and more expensive techniques (VFSS and FEES). Results may be translated into clinical practice in the management of swallowing disorders in a very vulnerable population, by reducing invasiveness, possible x-Ray early exposition risks, costs, medical complications, and by assessing risk categories based on neuroimaging MRI markers, to rationalize prevention and intervention.
Preliminary data. LUS examinations have been performed on 6 infants with neurological impairment (mean age 15 ± 8 months; Gross Motor Function Classification System (GMFCS) range 2-5, median=4) and in 3 healthy infants (mean age 25 ± 3 months) before and right after a meal. A LUS score ranging from 0 to 18 was established, according to previous literature (0= normal pattern, 1= separated B-lines, 2= confluent B-lines or B-lines with pleural alterations, 3= consolidations; the score 0-3 was then calculated in all 6 thoracic scanning areas and summed up). In the 6 infants with neurological impairment, at paired sample t test, LUS score changed before and after meal (pre-meal 2.50±2.95 vs post-meal 5.17±3.25, p=0.01), with very large effect size (Cohen d=1.6). No change was detected in the control group. Changes in LUS score pre and post-meal correlated with GMFCS (p=0.03, r=0.64) and with adapted Eating and Drinking Ability Classification System (EDACS) scores (p=0.04, r=0.59), as more severe clinical pictures resulted in worse LUS scores. The LUS score pre- meal was worse in infants with neurological impairment compared to controls (2.50±2.95 vs 0.67±0.58, p=0.14). Results make LUS extremely promising as a tool to monitor pulmonary aeration changes in infants with neurological impairment. Feasibility of dorsal and ventral oromotor tract reconstruction has been tested in an infant with neurological impairment.
Specific Aim 1:
- To establish the feasibility and effectiveness of LUS-guided management in the detection of aspiration related to swallowing disorders in children with cerebral palsy and other developmental disabilities, determining advantages of LUS-guided management over standard care on medical (respiratory illness and growth rate) LUS findings themselves and behavioural/neurological outcomes
- To compare diagnostic accuracy of LUS versus X-ray VFSS and invasive FEES
Specific Aim 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Both the clinicians who will perform and score LUS, and the patients' family will be blinded to randomization. The care providers (child neurologist and speech and language pathologist (SLP) will be informed of the result of LUS only in the LUS-m group and will include that result to impact on feeding care (postural, thickening fluids or with drugs available for GERD). LUS results in the SC-m group will be available only at the time of data analyses.
入排标准
- 年龄范围
- 3 Weeks 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cerebral palsy or abnormal muscular tone at any age between 0-3 years of life due disorders other than cerebral palsy;
- •motor developmental delay assessed by a quantitative scale for infants and young children development (<5 sd according to age)
- •in absence of the previous clinical indices, if there is the clinical suspicion of GERD or dysphagia based on clinical symptoms
- •a brain MRI acquisition done before or programmed prior the end of the study period as part of their diagnostic procedure.
排除标准
- •epileptic spasm
- •drugs for muscle tone abnormalities or GERD introduced or modified less than 3 weeks before potential enrollment
结局指标
主要结局
growth
时间窗: short term (T3, at 3 months)
growth rate
respiratory
时间窗: short term (T3, at 3 months)
respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)
invasive diagnostic
时间窗: short term (T3, at 3 months)
VFSS/FEES execution rates
次要结局
- chronic pain assessment(long term (T4, at 6 months))
- parents' stress(long term (T4, at 6 months))
- change from baseline laboratory exam at 6 months(baseline- long term (T4, at 6 months))
研究者
Simona Fiori
Principal Investigator, MD, PhD
IRCCS Fondazione Stella Maris