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临床试验/NCT03031288
NCT03031288已完成不适用

Vented Base Feeding Bottle in Preterm Infants With GERD Symptoms: Effects on Respiration-swallow Patterns and Reflux.

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Frequency of cardiorespiratory events (feeding+postprandial time)

研究概览

简要总结

Aim of the study is to evaluate the effects of vented base bottles on respiration-swallow patterns and on gastroesophageal refluxes in preterm infants with clinical suspect of gastroesophageal reflux disease (GERD).

In this crossover-randomized study, we compared the effects of standard feeding bottles (A) versus vented base feeding bottles (B) on a group of patients with at least 2 clinical GERD symptoms. 24 hours of synchronized cardiorespiratory (CR) and Esophageal Multichannel intraluminal impedance (MII/pH) monitoring were evaluated for each patient. During this period, patients were fed alternatively with feeding bottle A and B.

详细描述

In preterm infants a deficit of both coordination and gastro-intestinal motility is often the underpinning cause of oxygen desaturations and gastro-esophageal reflux. Breastfeeding enhances the maturation of the respiration-swallow mechanism. For this reason, a feeding bottle that best recreates the physiological sucking from the maternal breast is highly desirable in non-breastfed newborns.

Population: newborns referred to esophageal Multichannel Intraluminal Impedance and pH-metry (MII/pH) combined with cardiorespiratory (CR) monitoring for GERD or cardio-respiratory symptoms

Materials and methods: we compare the effects of traditional feeding bottles (A) versus vented base feeding bottles (B) on cardiorespiratory and reflux events in newborns undergoing 24 hours synchronized CR and MII/pH monitoring. During the exam, newborns are fed, alternatively, by feeding bottle A and B with human milk or formula. Some training meals are offered the day before monitoring to get newborns enrolled into the study used to vented base feeding bottles.

Cardiorespiratory monitoring is performed through VitaGuard VG3100® (Getemed Medizin- und Informationstechnik AG, Teltow, Germany) based on Masimo Signal Extraction Technology (SET)® (Masimo Corp., Irvine, CA, USA). It operates with a blood oxygen saturation (SpO2) detector, placed on the right wrist, and 3 thoracic electrodes. This instrument is able to record ECG, heart rate, SpO2 and thoracic plethysmographic curve. The signals are analyzed with VitaWin 3® software (Getemed Medizin - und Informationstechnik AG, Teltow, Germany), by filtering artifacts.

The MII/pH monitoring is performed through a neonatal catheter (Infant Comfort TEC®) with 7 impedence electrodes (creating 6 impedance channels) and one pH detector able to cover the whole distance from the pharynx to the lower esophageal sphincter (LES) (channel 1). The pH detector is placed within channel 1, 1.5 cm above the LES. The correct positioning of the catheter is measured through fluoroscopy and eventually corrected. Data obtained from impedance channels that result proximal to the superior esophageal sphincter are excluded from the analysis. The acquisition and recording of MII/pH data are performed through Sleuth System, Sandhill Scientific Inc., Highlands Ranch, Colorado, USA. The analysis of MII/pH tracings is made visually by a single operator using BioView 5.3.4 software (Sleuth System, Sandhill Scientific Inc., Highlands Ranch, Colorado, USA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
1 Week 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • weight ≥ 1500 g at the time of examination
  • at least 2 GERD symptoms
  • exclusive enteral feeding
  • parents' informed consent

排除标准

  • congenital abnormalities
  • perinatal asphyxia
  • respiratory, genetic, metabolic, infectious and/or neurologic disease
  • pharmacological therapies, in the last 7 days, able to affect esophageal motility

结局指标

主要结局

Frequency of cardiorespiratory events (feeding+postprandial time)

时间窗: calculated throughout 24 hour

Cardiorespiratory events / hour * apnea (no breathing movement for at least 20 s, or less if associated with desaturation/bradycardia) * desaturation (SpO2 \<80%) * bradycardia (heart rate \< 80 bpm for at least 1 s)

次要结局

  • Frequency of reflux events (postprandial time)(calculated throughout 150 minute interval after the end of the milk meal)
  • Swallow event characteristics (feeding time)(calculated throughout 30 minute interval after the beginning of the milk meal)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Cresi, MD, PhD

MD PhD

University of Turin, Italy

研究点 (2)

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