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Premature Infant Exposure to Noise Generated by Respiratory Support

2012年12月10日更新者：Jonathan Swanson, MD、University of Virginia

Infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory support modes (nasal continuous positive airway pressure - NCPAP and high flow nasal cannula: >1 L/min flow - HFNC). While there have been small descriptive studies of noise exposure in infants on NCPAP, there have been no comparative trials done comparing noise exposure in infants undergoing both NCPAP and HFNC.

Objective: Using a cross-over model determine noise exposure levels in infants exposed to similar levels of respiratory support provided by NCPAP and HFNC.

研究概览

地位

完全的

条件

新生儿早产

详细说明

Infants born < 32 weeks, in an incubator, and > 7 days postnatal that were maintained on either on NCPAP or HFNC to maintain SaO2 in a range of 88 - 92 %. Study infants had decibel measurements obtained every 15 seconds for 30 minutes using a noise dosimeter (NoisePro DLX-1). The microphone for the dosimeter was suspended from the inside of the incubator such that it hung 1 foot above the infants nose and mouth. The exhalation port for NCPAP was placed outside of the incubator. Repeated measurement periods on the same mode of support were made within a 72 hour period. Each infant the acted as their own control and was switched within 7 days to the alternative respiratory support method that maintained similar SaO2 goals and repeat measurements were obtained. Comparisons of mean decibel levels during recording were compared using paired t-tests.

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Virginia
  - Charlottesville、Virginia、美国、22908
    - University of Virginia Health System

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1周及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Infants born < 32 weeks, in an incubator, and > 7 days postnatal admitted to the Newborn Intensive Care Unit

描述

Inclusion Criteria:

Premature infant born < 32 weeks and 0 days post-conceptional age;
Seven or more days of age and not in acute respiratory distress;
Need for nasal continuous positive airway pressure or high-flow nasal cannula for ventilation or supplemental oxygen delivery;
In a neutral-thermal environment (i.e. isolette)

Exclusion Criteria:

Oro-facial congenital anomalies;
Congenital heart disease (except for patent ductus arteriosus and/or patent foramen ovale);
Unstable respiratory status as deemed by the attending physician
Patients under isolation for infectious disease

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Nasal CPAP Infants received nasal CPAP as standard of care.
High Flow Nasal Cannual Infants received high flow nasal cannula as standard of care.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Noise level 大体时间：6 days	Noise levels will be measured during a set time while infants are on Nasal CPAP and Nasal High flow cannula as standard of care	6 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Virginia

调查人员

首席研究员：Joshua Attridge, MD、UVA School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年11月1日

初级完成 (实际的)

2010年11月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2012年12月6日

首先提交符合 QC 标准的

2012年12月10日

首次发布 (估计)

2012年12月12日

研究记录更新

最后更新发布 (估计)