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Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV) (NIPPV)

2014年12月3日 更新者：McMaster University

Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants

The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?

研究概览

地位

完全的

条件

干预/治疗

详细说明

The immature lung of extremely low birth weight (ELBW, < 1000 g) infants is easily damaged by the placement of an endotracheal tube to deliver mechanical ventilation and oxygen. This and the total time of mechanical ventilation contributes to bronchopulmonary dysplasia (BPD). Infants with BPD have an increased risk of later death or neuro-impairment. With the increasing survival of ELBW infants in the NICU, there has been a proportionate increase in the number of infants surviving with BPD.

Following invasive ventilation via an endotracheal tube (ETT), extubation to nasal Continuous Positive Airway Pressure (nCPAP)ventilation is the standard approach. Currently, 40% of infants who are extubated and given nCPAP support fail, and require re-intubation. Previous work suggests that a less invasive respiratory support such as Nasal Intermittent Positive Pressure Ventilation (NIPPV), without an endotracheal tube is less injurious to the lung. NIPPV may thereby reduce the duration of invasive ventilator support, and aid successful early extubation. We hypothesize that the use of NIPPV leads to a higher rate of survival without BPD than standard therapy with nCPAP.

This randomized clinical trial is appropriately powered to compare NIPPV with nCPAP to detect effects on clinically relevant long-term outcomes, such as death and BPD at 36 weeks. This is a multi-national, randomized, open clinical trial of two different standard methods of providing non-invasive respiratory support to 1000 extremely preterm infants weighing less than 1000 grams at birth.

研究类型

介入性

注册 (实际的)

1011

阶段

  • 第三阶段

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

  • 加拿大
    • Manitoba
      • Winnipeg、Manitoba、加拿大
        • Winnipeg Health Sciences Centre
      • Winnipeg、Manitoba、加拿大、R3E 0L8
        • St. Boniface General Hospital/University of Manitoba
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大
        • IWK Health Centre
    • Ontario
      • Hamilton、Ontario、加拿大、L8S 4J9
        • McMaster University
      • Ottawa、Ontario、加拿大、K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Ottawa、Ontario、加拿大、K1H 8L6
        • The Ottawa Hospital General Campus
      • Toronto、Ontario、加拿大
        • Hospital for Sick Children
    • Saskatchewan
      • Saskatoon、Saskatchewan、加拿大
        • Royal University Hospital
  • 卡塔尔
      • Doha、卡塔尔
        • Hamad Medical Corporation
  • 奥地利
      • Feldkirch、奥地利、6800
        • LKH Feldkirch
  • 新加坡
      • Singapore、新加坡、229899
        • KK Women's and Children's Hospital
  • 比利时
      • Rocourt、比利时、B-4000
        • CHC St. Vincent
  • 爱尔兰
      • Dublin、爱尔兰
        • National Maternity Hospital
      • Dublin、爱尔兰
        • Coombe Women's Hospital
    • Cork
      • Wilton、Cork、爱尔兰
        • Cork University Maternity Hospital
  • 瑞典
      • Stockholm、瑞典、S-171 76
        • Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
  • 美国
    • District of Columbia
      • Washington、District of Columbia、美国、20037
        • The George Washington University Hospital
      • Washington、District of Columbia、美国、20007
        • Georgetown University Children's Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Medical Center (Bidmc)
      • Boston、Massachusetts、美国、02111
        • Tufts University Medical Center
    • New Jersey
      • Voorhees、New Jersey、美国、08043
        • Virtua West Jersey Hospital
    • New York
      • Brooklyn、New York、美国、11203
        • Kings County Hospital
      • Brooklyn、New York、美国、11023
        • SUNY Downstate Medical Center
      • Brooklyn、New York、美国、11355
        • New York Hospital Queens
      • Jamaica、New York、美国、11432
        • Queens Hospital Center
      • New York、New York、美国、11212
        • Brookdale University Hospital & Medical Center
      • Stony Brook、New York、美国、11794-8111
        • Stony Brook University Medical Center
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Children's Hospital of Philadelphia
      • Philadelphia、Pennsylvania、美国、19035
        • Pennsylvania Hospital/U. of Pennsylvania
    • Utah
      • Salt Lake City、Utah、美国、84158-1289
        • University of Utah
  • 英国
      • Leicester、英国、LE1 6TP
        • University of Leicester
      • London、英国、W2 1NY
        • St. Mary's Hospital
    • Northern Ireland
      • Belfast、Northern Ireland、英国、BT12 6BB
        • Royal Maternity Hospital
  • 荷兰
      • Groningen、荷兰、9700 RB
        • University Medical Center Groningen/Beatrix Children's Hosp
      • Zwolle、荷兰、8000 GK
        • Princess Amalia Dept of Pediatrics, Isala Clinics

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 4周 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Birth weight <1000 gm
  • Gestational age <30 completed weeks

  • Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:

    • the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support;
    • the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.

Exclusion Criteria:

  • Considered non-viable by clinician (decision not to administer effective therapies)
  • Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
  • Infants known to require surgical treatment
  • Abnormalities of the upper and lower airways
  • Neuromuscular disorders
  • Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube

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

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：A
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
设备：NIPPV
Deliver non-invasive respiratory support via ventilator with NIPPV device
有源比较器：B
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
设备：nCPAP
Deliver non-invasive respiratory support via ventilator with nCPAP device

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
大体时间：36 weeks gestational age
36 weeks gestational age

次要结果测量

结果测量
大体时间
孕周 36 周时的全因死亡率
大体时间：孕周36周
孕周36周
早产儿视网膜病变
大体时间：出院回家
出院回家
All cause mortality before first discharge home
大体时间：first discharge home
first discharge home
ultrasonographic evidence of brain injury
大体时间：36 weeks gestional age
36 weeks gestional age
necrotizing enterocolitis
大体时间：36 weeks gestational age
36 weeks gestational age
growth
大体时间：discharge home
discharge home
time to establish full feeds
大体时间：discharge home
discharge home
nosocomial infections
大体时间：discharge home
discharge home
need for re-intubation
大体时间：36 weeks gestational age
36 weeks gestational age
time on supplemental oxygen
大体时间：discharge home
discharge home
duration of positive pressure respiratory support
大体时间：discharge home
discharge home
comparison of synchronized and non-synchronized NIPPV
大体时间：discharge home
discharge home
bronchopulmonary dysplasia
大体时间：36 weeks gestational age
36 weeks gestational age
air leak syndromes
大体时间：36 weeks gestational age
36 weeks gestational age
nasal trauma
大体时间：discharge home
discharge home

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

McMaster University

合作者

Canadian Institutes of Health Research (CIHR)

调查人员

  • 学习椅：Haresh Kirpalani, MD, MSc、Hamilton Health Sciences Corporation
  • 研究主任：Brigitte Lemyre, MD、Children's Hospital of Eastern Ontario
  • 研究主任：Aaron Chiu, MD、St. Boniface Hospital
  • 研究主任：David Millar, MD、Royal Maternity Hospital, Belfast
  • 研究主任：Robin S Roberts, MTech、Hamilton Health Sciences/McMaster University
  • 研究主任：Bradley Yoder, MD、University of Utah
  • 研究主任：Peter H Dijk, MD, PhD、University Medical Centrum Groningen

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

2007年4月1日

初级完成 (实际的)

2011年8月1日

研究完成 (实际的)

2011年12月1日

研究注册日期

首次提交

2007年2月7日

首先提交符合 QC 标准的

2007年2月8日

首次发布 (估计)

2007年2月9日

研究记录更新

最后更新发布 (估计)

2014年12月5日

上次提交的符合 QC 标准的更新

2014年12月3日

最后验证

2014年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NTG-2007-NIPPV
  • CIHR MCT-80246
  • ISRCTN15233270

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.

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