NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)

Summary

The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in premature infants with RDS．

Conditions

• Preterm Infants

Interventions

PROCEDURE

noninvasive high-frequency ventilation (nHFOV)

NHFOV will be provided by a high frequency ventilator (CNO, Medin, Germany or SLE 5000, UK). NHFOV will be provided via binasal prongs.

PROCEDURE

nasal continuous positive airway pressure (nCPAP)

Infants assigned to the NCPAP group will be started on a pressure of 6 cmH2O (range: 6-8 cmH2O) by CPAP system (CNO Medin, Germany, Carefusion, USA)

Sponsors & Collaborators

• Guiyang Maternity and Child Health Care Hospital

  collaborator OTHER

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

  collaborator OTHER

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Chongqing Maternal and Child Health Hospital

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Yan'an Affiliated Hospital of Kunming Medical University

  collaborator OTHER

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

  collaborator OTHER

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Zhengzhou Children's Hospital, China

  collaborator OTHER

• Chengdu Women's and Children's Central Hospital

  collaborator OTHER

• The People's Hospital of Dehong Autonomous Prefecture

  collaborator OTHER

• Kunming Children's Hospital

  collaborator OTHER

• Chongqing Three Gorges Central Hospital

  collaborator OTHER

• Shanxi Provincial Maternity and Children's Hospital

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Vilnius University

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Guangdong Women and Children Hospital

  collaborator OTHER

• Nanjing Children's Hospital

  collaborator OTHER

• Xingwang Zhu

  lead OTHER

Principal Investigators

• Shi Yuan, PhD · Third Military Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

12 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-27

Primary Completion

2018-07-28

Completion

2018-07-28

Countries

• China

Study Locations