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临床试验/NCT01785563
NCT01785563已完成不适用

Nasal Noninvasive NAVA Provides Ventilation in the Very Low Birth Weight Infant

Tarah T Colaizy4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
4
主要终点
Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas

研究概览

简要总结

The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely. Investigators are looking to determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved in their blood as compared to prior to starting the study. This will be accomplished by enrolling infants who are stable on their current type of mechanical breathing that provides a constant air flow into the infant. This type of mechanical support helps keep the lungs inflated but does not help remove carbon dioxide. This study will change the type of mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA. This type of mechanical support detects when the infant is breathing in by having electrical sensors on a feeding tube that is placed into the stomach through the nose or mouth. These electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides additional air flow to make the effort of breathing easier. The ventilator will be attached to a tube or cannula that is placed into the infant's nose. After two hours of being on the NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a small amount of blood from the infant's heel.

详细描述

Baseline Data Collection:

Demographic data: Patient gestational age at delivery, maternal betamethasone therapy, APGAR scores, admission weight, receipt of surfactant administered, age at extubation, time since extubation, current post menstrual age, and current weight.

Baseline vitals and ventilation mode: Heart rate, blood pressure, FiO2 (fraction of inspired oxygen), oxygen saturations, transcutaneous partial pressure of carbon dioxide (TCO2) and current mode of ventilation will be recorded four times in a one minute period and the values average to minimize normal variation. Intervention time will be manipulated to begin no later than one hour after the previous feeding, as to minimize interruption of feedings to no greater than 30 minutes.

Safety Safety: TCO2 monitor will be attached to the infant and the device will be calibrated according to protocol (reference TCO2 monitor manual). Carbon dioxide diffusion through the skin will be monitored continuously during the intervention (Bromley 08) to avoid periods of hypo or hypercarbia.

Edi (electrical activity of the diaphragm) Catheter placement: Edi catheter size will be selected according to infant's weight and length. It will be inserted according to manufacturer's guidelines and adjustments will be made to optimize positioning (reference NAVA manual).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Days 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • birth weight less than 1,500 grams
  • Clinical history of respiratory distress syndrome treated with surfactant
  • Chronological age greater than or equal to seven days
  • 48 hours post-extubation or greater
  • Medically stable per primary medical team
  • Receiving ventilatory support on one of the following systems via nasal pharyngeal tube or nasal prongs:continuous positive airway pressure (CPAP), intermittent mechanical ventilation (IMV), or neutrally adjusted ventilatory assistance (NAVA)
  • Receiving ventilatory support via high flow nasal cannula if the flow is large enough to provide a positive end expiratory pressure (PEEP) of 6 as defined by PEEP of 6 = 0.68 * weight (kg) + 0.92
  • Capillary blood gas via heel stick within 24 hours that demonstrates a pH of less than or equal to 7.35 and/or a partial pressure of carbon dioxide (pCO2) greater than or equal to 45 mmHg
  • Exclusion criteria:
  • Severe congenital abnormalities
  • Grade III or IV interventricular hemorrhage.

排除标准

  • 未提供

结局指标

主要结局

Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas

时间窗: 2 hours

difference between pCO2 (mm Hg) on capillary blood gas obtained within 6 hours of study and immediately after 2 hour study period

次要结局

  • Change in Fraction of Inspired Oxygen(2 hours)

研究者

发起方
Tarah T Colaizy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tarah T Colaizy

Principal Investigator

University of Iowa

研究点 (4)

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