NHFOV as Primary Support in Very Preterm Infants With RDS

Summary

This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 28 weeks when used as a primary noninvasive ventilation (NIV) mode.

Conditions

• to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates

Interventions

PROCEDURE

infants receive primary non-invasive respiratory support by mean of nCPAP

neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-10 cmH2O) , with FiO2 (0.21-0.40)adjusted to target SpO2 from 89% to 94%. CPAP will be provided by either variable flow or continuous flow devices, as there is no clear evidence that one type of CPAP generator would be better than any other by pure CPAP system.

PROCEDURE

infants receive primary non-invasive respiratory support by mean of NHFOV

neonates assigned to NHFOV will be started with the following boundaries: a) Paw of 6 cmH2O (the range 6-10 cmH2O); b) frequency of 10 Hz (the range 8-12 Hz). c) Inspiratory time 50% (1:1). d) amplitude 15 cmH2O(the range 15-25 cmH2O) NHFOV will only be provided with piston/ membrane oscillators able to provide an active expiratory phase (that is, Acutronic FABIAN-III, SLE 5000, Loweinstein Med LEONI+, Sensormedics 3100A).

Sponsors & Collaborators

• Jiangxi Maternal and Child Health Hospital

  collaborator OTHER

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Guiyang Maternity and Child Health Care Hospital

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Hunan Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• Zhangzhou Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• Women and Children's Health Hospital of Yulin

  collaborator OTHER

• Chongqing Three Gorges Central Hospital

  collaborator OTHER

• Gansu Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Chengdu Women's and Children's Central Hospital

  collaborator OTHER

• Maternal and Children's Healthcare Hospital of Taian

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Quanzhou Children's Hospital

  collaborator OTHER

• Chongqing West Hospital

  collaborator OTHER

• Chongqing Medical Center for Women and Children

  collaborator OTHER

• Xiamen Maternity & Child Care Hospital

  collaborator OTHER

• Qujing Maternal and Child Health Hospital

  collaborator OTHER

• Liuzhou Maternity and Child Healthcare Hospital

  collaborator OTHER

• International Peace Maternity and Child Health Hospital

  collaborator OTHER

• Jiulongpo No.1 People's Hospital

  lead OTHER

Principal Investigators

• Yuan Shi, PhD · Children's Hospital of Chongqing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Hours

Max Age

2 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2024-08-05

Completion

2024-08-05

Countries

• China

Study Locations