此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Fitting of Commonly Available Face Masks for Late Preterm and Term Infants (CAFF)

2019年5月29日 更新者:University Hospital Tuebingen

Around ten percent of newborn infants require positive pressure ventilation (PPV) in the delivery room. This is most commonly delivered using a round or anatomically shaped face mask attached to a T-piece device, self-inflating bag or flow-inflating bag. Face mask ventilation is a challenging technique and difficult to ensure that an appropriate tidal volume is delivered because large and variable leaks occur between the mask and face.

It is recommended by International Guidelines to start with mask ventilation by placing a fitting face mask on the babies face.

A fitting face mask covers the mouth and nose. A non-fitting overlaps the eyes and the chin, which causes a airleak. Studies report variable leak, sometimes more than 50% of inspiratory volume, during PPV in preterm infants in the delivery room. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation.

A study performed in preterm infants showed that most masks available are too big for the majority of those infants.

The investigators hypothesis is that the commonly available face masks for term infants are similarly too big for some term and late preterm infants (≥ 34 weeks gestation).

研究概览

详细说明

The investigators would like to measure the dimensions of the faces of late preterm and term infants (≥ 34 SSW) within the first 72 hours of life and compare this data with the size of the most recommended available face masks:

VBM Germany:

external diameter smaller mask: 50 mm, external diameter bigger mask: 70 m

Laerdal:

external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm

Fisher&Paykel:

external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm

Therefore the investigators want to collect the following information from the participants:

Picture of the participant´s face (2D and 3D-Image) birth weight, head circumference, mode of delivery, gestational age, singletons/ twins/ triplets, date of birth

研究类型

观察性的

注册 (实际的)

100

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

      • Tuebingen、德国、72072
        • University Clinic Tuebingen

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

不超过 3天 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

  • Late preterm and term infants, gestational week ≥ 34 +0
  • 10 to 15 patients in every gestational-week
  • born at the University Hospital of Tuebingen
  • signed declaration of consent from the parents
  • ≤ 72 hours

描述

Inclusion Criteria:

  • Late preterm and term infants, gestational week ≥ 34 +0
  • born at the University Hospital of Tuebingen
  • signed declaration of consent from the parents
  • ≤ 72 hours

Exclusion Criteria:

  • congenital facial anomalies
  • any respirators or other medical device that covers the face
  • missing declaration of consent from the parents

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

队列和干预

团体/队列
干预/治疗
2d and 3D image
A 2D and 3D image of the participants' face will be taken. It will at least last 2-3 sec.
2D and 3D image of infants´ faces

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
Mouth: Find out the best fitting facemask
大体时间:1 year
Measure distance in millimeters with ImageJ and 3DMaxSoftware from the nasofrontal groove to the mental protuberance and determine if the commonly available face masks fit this study population.
1 year
Lips: Find out the best fitting facemask
大体时间:1 year
Measure the lateral points located at each labial commissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
1 year
Eyes: Find out the best fitting facemask
大体时间:1 year
Measure the points at the inner commissure of the eye fissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
1 year
Chin: Find out the best fitting facemask
大体时间:1 year
Measure length of the chin in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
1 year

次要结果测量

结果测量
措施说明
大体时间
Gestational age
大体时间:1 year
Correlation between gestational age and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
1 year
Birth weight
大体时间:1 year
Correlation between birthweight and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
1 year
headcircumference
大体时间:1 year
Correlation between headcircumference and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
1 year
gender: male/female
大体时间:1 year
Correlation between gender (male/female) and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
1 year
way of delivery: spontaneous/cesarean
大体时间:1 year
Correlation between way of delivery and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware..
1 year

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (实际的)

2018年4月10日

初级完成 (实际的)

2019年1月30日

研究完成 (实际的)

2019年1月30日

研究注册日期

首次提交

2017年11月24日

首先提交符合 QC 标准的

2017年12月4日

首次发布 (实际的)

2017年12月11日

研究记录更新

最后更新发布 (实际的)

2019年5月30日

上次提交的符合 QC 标准的更新

2019年5月29日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • CAFF

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅