Brainstem Dysfunction Involvement in the Pathogenesis of Pierre Robin Sequence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 4
- 主要终点
- Central apnea index (CAI) (mean number per hour)
研究概览
简要总结
Introduction Pierre Robin Sequence, PRS, incidence is about one hundred births per year in France. The main neonatal clinical manifestations are secondary to airway obstruction and food difficulties related to swallowing disorders. Despite recent progress, the pathogenesis of PRS is not fully understood.
The hypothesis is that brainstem dysfunction, BSD, plays a central role in the pathogenesis of PRS.
The purpose of the study is to achieve a complete evaluation of BSD to specify its role in the pathogenesis of PRS.
The primary objective is to compare central apnea index (CAI) of infants with PRS with those of infants with isolated airway obstruction (AWO) and those of healthy infants in order to clarify the direct role of BSD.
Material and Methods This prospective interventional study will be carried out in Lyon at the Hôpital Femme-Mère-Enfant and in Paris at the Hôpital Necker-Enfants Malades for 2 years. 3 groups of patients will be studied: PRS, 50 patients, AWO, 50 patients and healthy, 30 patients, included before 2 months of life. Infants will be followed for a maximum of 10 months. The evaluations will be carried out for 48 hours between birth and 2 months of life and then for 24 hours between 6 and 10 months of life for PRS and AWO group. Concerning the healthy group, the evaluation will be carried out during 48h during a single hospitalization before 2 months. Polysomnography, holter-ECG, 24h gas exchange, impedance-pH monitoring and mental region EEG will be performed. The central apnea index (mean number per hour), obstructive apnea index, non-nutritive swallowing index (NNS), gastroesophageal reflux and NNS-respiration coordination will be assessed for each stage of sleep and compared between the three groups of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Birth before 37 SA
- •Neonatal complication
- •Group 2 only: AWO with neurological disease including brainstem dysfunction
- •Group 3 only : AWO, ENT disease or syndromic disease, neurological disease including brainstem dysfunction, Intra uterine growth retardation
结局指标
主要结局
Central apnea index (CAI) (mean number per hour)
时间窗: 2 months of life during one nocturne polysomnography
To compare central apnea index (CAI) (mean number per hour), according to the ASSM guidelines 2007, recording by one nocturne polysomnography, between 3 groups of infants by sleep step, between birth and 2 months of life, in order to clarify the direct role of BSD. According to the ASSM guidelines 2007, the central apnea index is measured : mean number of central apnea per hour.
次要结局
- Non-nutritive swallowing index (NNS) and apnea secondary to non-nutritive swallowing(up to 10 months of life)
- Micro arousals index (mean number per hour)(up to 10 months of life)
- Obstructive apnea hypopnea index (OAHI)(mean number per hour)(2 months)
- Positive and negative pressures, their temporal organizations evaluated using succimetry procedure between the 3 groups of patients at 0 and 2 months of life(up to 2 months of life)
- Comparison of OAHI(mean number per hour) and CAI(between 6 and 10 months of life)