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临床试验/NCT02661256
NCT02661256已完成不适用

Effect of Nasal Continuous Positive Airway Pressure on The Pharyngeal Swallow in Neonates

NYU Langone Health0 个研究点目标入组 7 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
主要终点
Pharyngeal Phase Dysphagia

研究概览

简要总结

Oral feeding of neonates while on nasal continuous positive airway pressure (NCPAP) is a common practice in many neonatal intensive care units (NICU) all over the country. However the safety of such practice has never been established. The Investigators hypothesize that mechanoreceptors, which should perceive sensory input from the liquid bolus, may be altered by the reception of pressurized airflow provided by the NCPAP, hence increase risk of aspiration. In this study, changes in the pharyngeal phase of swallowing were identified using video fluoroscopic swallow studies (VFSS) for infants while on NCPAP as compared to off NCPAP.

详细描述

Preterm infants with underdeveloped lungs and term infants with cardio-respiratory illness frequently need to be placed on ventilatory assistance. Nasal Continuous Positive Airway Pressure (NCPAP) has been proven to be an effective mode of noninvasive ventilation in neonates, as it delivers positive pressure to the airway throughout the respiratory cycle. NCPAP works by improving the breathing pattern in neonates; it increases the mean airway pressure, stents the upper airway, decreases proximal airway resistance, reduces physiological dead space, optimizes lung recruitment and improves diaphragmatic function. While many infants in the Neonatal Intensive Care Units (NICUs) require NCPAP, many of their other medical and developmental needs such as initiating oral feedings need to be addressed. Oral feeding of neonates while on NCPAP is a common practice in many NICUs, however the effect of such practice on neonatal swallowing mechanism has never been investigated.

Swallowing is a complex sensorimotor function that allows infant to safely and effectively ingest liquid nutrition. The ability of an infant to successfully feed is dependent on the precise interconnection of anatomy, physiology and neurology pathways. Afferent sequences play an integral role in the infant swallowing mechanism as sensory feedback is required during all phases of swallowing to allow appropriate positioning of anatomic structures, as well as to modulate the strength, velocity, and timing of muscle contractions. Sensory information is received from various types of sensory receptors distributed throughout the oral cavity, pharynx, larynx and esophagus. Localized areas of the infant's anatomy are known to have particular types of sensory receptors that are excited by specific stimuli which elicit appropriate motor movements.

One of the most densely populated sensory receptors are the mechanoreceptors which are sensitive to touch and pressure to help decipher the shape, texture, size and temperature of the bolus about to be swallowed. The mechanoreceptors are also sensitive to the pressure and movement of air flow during breathing.

The sensations perceived by these receptors are responsible for sending afferent sensory information to the medullary region of the brainstem where they are processed by the central pattern generators (CPGs). CPGs are composed of dedicated networks of interneurons that are responsible to sequence and activate different motor neurons at specified intensities to generate motor patterns. Both the swallowing CPG and the respiratory CPG are housed within the medulla. The close proximity of these neurons allows for precise swallow and breathing coordination. A close interrelationship between the swallowing and respiratory processes is further evident as they encompass shared anatomic structures and muscular components within the pharynx, and act as physiologically and biomechanically reciprocal events.

This close interrelationship between swallowing and breathing has led to some controversy and difference in opinion among neonatologists on the decision to start oral feedings while on NCPAP. Although there is no research directly related to the effect of NCPAP on swallowing process in neonates, NCPAP has been reported to induce dilatation of the laryngeal opening in preterm infants and inhibit the swallow reflex in adults.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
34 Weeks 至 45 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants in neonatal ICU requiring NCPAP and tolerating at least 50% of their total required intake by mouth from a bottle, as determined by their medical team.

排除标准

  • Infants with other comorbidity such as upper airway anomalies, brain injury neuromuscular disease, life threatening congenital disease. Any symptomatic intercurrent acute disease e.g. infectious disease

研究组 & 干预措施

on NCPAP

Active Comparator

Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.

干预措施: NCPAP (Device)

on NCPAP

Active Comparator

Once consented, each participant underwent a video fluoroscopic swallow study (VFSS) while NCPAP was administered via a RAM cannula® (intervention). With the NCPAP turned on each participant was fed room temperature thin liquid barium (Varibar® Thin Liquid Barium Sulfate for Suspension) from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow), a total of 20 swallows were recorded. These swallows were termed "on NCPAP" swallows. The swallows were assessed in real time for any swallowing dysfunction.

干预措施: Varibar® Thin Liquid Barium Sulfate for Suspension (Dietary Supplement)

Off NCPAP

Active Comparator

Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.

干预措施: NCPAP (Device)

Off NCPAP

Active Comparator

Immediately following the "on NCPAP" condition, an additional 20 swallows were recorded under VFSS with the NCPAP turned off (intervention). These swallows were termed "off NCPAP" swallows.

干预措施: Varibar® Thin Liquid Barium Sulfate for Suspension (Dietary Supplement)

结局指标

主要结局

Pharyngeal Phase Dysphagia

时间窗: <5 seconds post swallow trigger

presence of atypical or disordered movements during the pharyngeal phase of swallowing

次要结局

  • Silent Aspiration(<5 seconds post swallow trigger)
  • Nasopharyngeal Reflux(<2 seconds post swallow trigger)
  • Pharyngeal Residue(<5 seconds post swallow trigger)
  • Tracheal Aspiration(<5 seconds post swallow trigger)
  • Percentage of Laryngeal Length(<2 seconds post swallow trigger)

研究者

申办方类型
Other
责任方
Sponsor

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