A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation

Summary

Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm neonates, its incidence varying from 80% to 25% depending on gestational age.When optimal prenatal care is provided, the best approach to treat RDS, according to several recent trials,consists in providing continuous positive airway pressure (CPAP) from the first minutes of life using short binasal prongs or masks, followed by early selective surfactant administration for babies with worsening oxygenation and/or increasing work of breathing. Any effort should be done to minimize the time under invasive mechanical ventilation (IMV).Nonetheless, clinical trials have shown that a relevant proportion of preterm neonates fails this approach and eventually need IMV.The duration of IMV is a well known risk factor for the development of broncho-pulmonary dysplasia (BPD) - a condition associated with significant morbidity and mortality.

To minimize the duration of IMV, various non invasive respiratory support modalities are available in neonatal intensive care units (NICU). CPAP is presently the most common technique used in this regard. However, a systematic review has shown that non-invasive positive pressure ventilation (NIPPV) reduces the need for IMV (within one week from extubation) more effectively than NCPAP, although it is not clear if NIPPV may reduce need for intubation longterm and it seems to have no effect on BPD and mortality. NIPPV main drawback is the lack of synchronization, which is difficult to be accurately achieved and is usually unavailable. A more recent alternative technique is non-invasive high frequency oscillatory ventilation (NHFOV) which consists on the application of a bias flow generating a continuous distending positive pressure with oscillations superimposed on spontaneous tidal breathing with no need for synchronization. The physiological, biological and clinical details about NHFOV have been described elsewhere.

To date, there is only one small observational uncontrolled study about the use of NHFOV after extubation in preterm infants. Other relatively small case series or retrospective cohort studies suggested safety, feasibility and possible usefulness of NHFOV and have been reviewed elsewhere.The only randomized trial published so far compared NHFOV to biphasic CPAP,in babies failing CPAP and it has been criticized for methodological flaws and for not taking into account respiratory physiology.An European survey showed that, despite the absence of large randomized clinical trials, NHFOV is quite widely used, at least in some Countries and no major side effects are reported, although large data about NHFOV safety are lacking. This may be due to the relative NHFOV easiness of use but evidence-based and physiology-driven data are warranted about this technique.

Conditions

• Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies

Interventions

DEVICE

NHFOV

Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.

DEVICE

NCPAP

Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.

DEVICE

NIPPV

Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Jiulongpo No.1 People's Hospital

  collaborator OTHER

• Chongqing Maternal and Child Health Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Children's Hospital of The Capital Institute of Pediatrics

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• First Hospital of Tsinghua University

  collaborator OTHER

• Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Quanzhou Children's Hospital

  collaborator OTHER

• Xiamen Maternity & Child Care Hospital

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Guangdong Academy of Medical Science and General Hospital

  collaborator OTHER

• Guangdong Women and Children Hospital

  collaborator OTHER

• Women and Children's Health Hospital of Yulin

  collaborator OTHER

• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Guiyang Maternal and Child Health Care Hospital

  collaborator OTHER

• Zunyi First People's Hospital

  collaborator INDUSTRY

• Lanzhou University Second Hospital

  collaborator OTHER

• Gansu Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Zhengzhou Children's Hospital, China

  collaborator OTHER

• Third Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• the Maternal and Child Health Hospital of Hainan Province

  collaborator OTHER

• Bethune International Peace Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Children's Hospital of Nanjing Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Maternal and Children's Healthcare Hospital of Taian

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Shanxi Provincial Maternity and Children's Hospital

  collaborator OTHER

• Chengdu Women and Children's Center Hospital

  collaborator OTHER

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• Affiliated Hospital of Southwest Medical University

  collaborator OTHER

• Shenzhen People's Hospital, The Second Medical College of Jinan University

  collaborator OTHER

• Tianjin Central Hospital of Gynecology Obstetrics

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Kunming Children's Hospital

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Yan'an Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Women and Children's Health Hospital of Qujing

  collaborator OTHER

• The People's Hospital of Dehong Autonomous Prefecture

  collaborator OTHER

• The First People's Hospital of Yinchuan

  collaborator OTHER

• The Children's Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Beijing 302 Hospital

  collaborator OTHER

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Women and Children Hospital of Qinghai Province

  collaborator OTHER

• Jiangxi Province Children's Hospital

  collaborator OTHER

• Inner Mongolia People's Hospital

  collaborator OTHER

• Mianyang Central Hospital

  collaborator OTHER

• People's Liberation Army No.202 Hospital

  collaborator OTHER

• Ningbo Women & Children's Hospital

  collaborator OTHER

• Shanghai Children's Medical Center

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Nanjing Medical University

  collaborator OTHER

• Qinhuangdao Maternal and Child Health Care Hospital

  collaborator OTHER

• Xuzhou Children Hospital

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Xianyang Children's Hospital

  collaborator OTHER

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  lead OTHER

Principal Investigators

• Shi Yuan, PhD,MD · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Minutes

Max Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2021-05-31

Completion

2021-06-30

Countries

• China

Study Locations