NHFOV as Primary Support in Very Preterm Infants With RDS

NACompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

August 1, 2022

Primary Completion Date

August 5, 2024

Study Completion Date

August 5, 2024

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).

Trial Locations (3)

Unknown

Hunan Provincial Maternal and Child Health Care Hospital, Changsha

The Second Hospital of Shandong University, Jinan

Qujing Maternity and cChild Healthcare Hospital, Qujing

All Listed Sponsors
collaborator

Jiangxi Maternal and Child Health Hospital

OTHER

collaborator

Children's Hospital of Chongqing Medical University

OTHER

collaborator

Guiyang Maternity and Child Health Care Hospital

OTHER

collaborator

The Second Hospital of Shandong University

OTHER

collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

OTHER

collaborator

Hunan Provincial Maternal and Child Health Care Hospital

OTHER

collaborator

Zhangzhou Affiliated Hospital of Fujian Medical University

OTHER

collaborator

Women and Children's Health Hospital of Yulin

OTHER

collaborator

Chongqing Three Gorges Central Hospital

OTHER

collaborator

Gansu Provincial Maternal and Child Health Care Hospital

OTHER

collaborator

The First People's Hospital of Yunnan

OTHER

collaborator

Chengdu Women's and Children's Central Hospital

OTHER

collaborator

Maternal and Children's Healthcare Hospital of Taian

OTHER

collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

collaborator

Quanzhou Children's Hospital

OTHER

collaborator

Chongqing West Hospital

OTHER

collaborator

Chongqing Medical Center for Women and Children

OTHER

collaborator

Xiamen Maternity & Child Care Hospital

OTHER

collaborator

Qujing Maternal and Child Health Hospital

OTHER

collaborator

Liuzhou Maternity and Child Healthcare Hospital

OTHER

collaborator

International Peace Maternity and Child Health Hospital

OTHER

lead

Jiulongpo No.1 People's Hospital

OTHER