Esophageal Bolus Transit in GERD Newborns: a Multichannel Intraluminal Impedance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- BPT, BHAT, BHATc
研究概览
简要总结
Esophageal dysmotility due to immaturity could promote impaired bolus transit during esophageal swallow events,thus influencing gastroesophageal reflux (GER) clearance.
Aim of this study was to describe esophageal bolus transit characteristics during swallow and to evaluate the relationship between esophageal swallow (ES) and GER in newborns with gastroesophageal reflux disease symptoms using multichannel intraluminal impedance.
The simultaneous analysis of swallow and GER events in newborns undergone MII/pH monitoring could provide useful information to better understand the physiopathology of gastroesophageal reflux disease (GERD) and could help clinicians to identify newborns with prolonged esophageal clearance time, making the recommendations for further tests and the therapeutic approach more accurate
详细描述
The aim of this study was to evaluate esophageal swallow (ES) frequency and characteristics in term and preterm newborns with GERD symptoms using MII and to investigate the possible relationship between ES and GER events.
MATERIAL AND METHODS
The MII tracings from the beginning of the second feeding up to 3 hours after the end of the meal were visually analyzed by two independent investigators using Bioview Analysis software (Sandhill Scientific Inc., Highlands Ranch, Colorado, USA) to identify and characterize ES and GER events.
ES events An ES event was identified as a rapid increase in impedance which precedes a drop in impedance to 50% of baseline beginning in the proximal channel and preceding in an anterograde direction to the most distal channel, followed by the recovery of baseline values at each channel.13 The ES events detected by MII/pH were grouped into mealtime events (the first nine consecutive ES events with no artifacts after the beginning of the meal) and postprandial period events (all the ES events detected in the 3 hours following the end of the meal).
ES event frequency (ES events/hour) was measured, along with the following ES event characteristics:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical presentations included regurgitation/vomiting, apnea and desaturations, coughing, feed refusal, irritability, crying, back arching, failure to thrive.
排除标准
- •Presence of congenital abnormalities, perinatal asphyxiation or neurological pathologies Taking drug known to influence esophageal motor function. Anti-reflux treatment was ceased 1 week before MII/pH.
结局指标
主要结局
BPT, BHAT, BHATc
时间窗: calculated throughout 24 hours
bolus presence time (BPT): time between bolus entrance and exit recorded in the distal channel, measured in seconds; bolus head advancing time (BHAT): time between the bolus entrance recorded in the proximal channel and the bolus entrance recorded in the distal channel, measured in seconds; bolus head advancing time corrected (BHATc): BHAT corrected for esophageal length, expressed in seconds/cm. BHATc was calculated using the formula BHATc = BHAT / esophageal length
次要结局
未报告次要终点
研究者
Francesco Cresi, MD, PhD
MD
University of Turin, Italy