NHFOV as Primary Support in Very Preterm Infants With RDS

NCT05141435 | Completed Results DMC

• 1 other identifier: NHFOV prevent intubation
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

nasal high frequency oscillation ventilation(NHFOV); nasal continuous positive airway pressure(NCPAP); preterm infants

Outcome Measures

Primary Outcomes (1)

• Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation

  The respiratory support failure will be considered if one of the following occurs: (1) severe respiratory acidosis (defined as PaCO2 \>60mm Hg with pH\<7.2) for at least 1hour; (2) hypoxia refractory to study intervention (defined as SpO2 \<90%, with FiO2=0.4 and maximal pressures allowed in the study arm) for at least 1 hour after the administration of surfactant; (3) severe apnoea (defined as recurrent apnoea with \>3 episodes/hour associated with heart rate \<100/min or a single episode of apnoea requiring bag and mask ventilation) and (4) attending physician determined that urgent intubation is necessary.

  within 72 hrs from the beginning of the study mode

Secondary Outcomes (1)

• Rate of Airleaks(Pneumothorax and/or Pneumomediastinum) Occurred During Noninvasive Respiratory Support

  the first 4weeks of life or until NICU discharge, whichever comes first

Other Outcomes (12)

• Rate of Bronchopulmonary Dysplasia

  36 weeks of postmenstrual age

• Rate of Retinopathy of Prematurity (ROP)≥ 2nd Stage

  the first 4weeks of life or until NICU discharge, whichever comes first

• Rate of Necrotizing Enterocolitis (NEC) ≥ 2nd Stage

  the first 4weeks of life or until NICU discharge, whichever comes first

Study Arms (2)

NCPAP

ACTIVE COMPARATOR

Procedure: infants receive primary non-invasive respiratory support by mean of nCPAP; Procedure: infants receive primary non-invasive respiratory support by mean of NHFOV

NHFOV

ACTIVE COMPARATOR

Procedure: infants receive primary non-invasive respiratory support by mean of nCPAP; Procedure: infants receive primary non-invasive respiratory support by mean of NHFOV

Interventions

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

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.

NCPAP; NHFOV

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

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).

NCPAP; NHFOV

Eligibility Criteria

• Age: 0 Hours - 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (1) Gestational age between 240/7 and 286/7 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (FiO2) greater than 0.25 for target saturation of peripheral oxygen (SpO2) 89% to 94%；（3） Age less than 2 hours

You may not qualify if:

• Intubated forany reasons at birth
• Major congenital malformations or known complex congenital heart disease
• No parental consent

Sponsors & Collaborators

• Jiulongpo No.1 People's Hospital: lead
• Jiangxi Maternal and Child Health Hospital: collaborator
• Children's Hospital of Chongqing Medical University: collaborator
• Guiyang Maternity and Child Health Care Hospital: collaborator
• The Second Hospital of Shandong University: collaborator
• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Hunan Provincial Maternal and Child Health Care Hospital: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator
• Women and Children's Health Hospital of Yulin: collaborator
• Chongqing Three Gorges Central Hospital: collaborator
• Gansu Provincial Maternal and Child Health Care Hospital: collaborator
• The First People's Hospital of Yunnan: collaborator
• Chengdu Women's and Children's Central Hospital: collaborator
• Maternal and Children's Healthcare Hospital of Taian: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Quanzhou Children's Hospital: collaborator
• Chongqing West Hospital: collaborator
• Chongqing Medical Center for Women and Children: collaborator
• Xiamen Maternity & Child Care Hospital: collaborator
• Qujing Maternal and Child Health Hospital: collaborator
• Liuzhou Maternity and Child Healthcare Hospital: collaborator
• International Peace Maternity and Child Health Hospital: collaborator

Study Sites (3)

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

The Second Hospital of Shandong University

Jinan, Shandong, China

Location

Qujing Maternity and cChild Healthcare Hospital

Qujing, Yunnan, China

Location

Related Publications (2)

• Li Y, Zhu X, Li LJ, Chen L, Yang Q, Xu L, Liang W, Lin X, Li C, Xue J, Liu L, Pan X, Ju R, Peng X, Tang W, Shi Y; NHFOV study group. Non-invasive high frequency oscillatory ventilation for primary respiratory support in extremely preterm infants: multicentre randomised controlled trial. BMJ. 2025 Oct 6;391:e085569. doi: 10.1136/bmj-2025-085569.

  PMID: 41052898 DERIVED

• Li Y, Zhu X, Shi Y; Noninvasive High-Frequency Oscillatory Ventilation Study Group. Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in extremely preterm infants with respiratory distress syndrome: study protocol for a multicentre randomised controlled, superiority trial. BMJ Open. 2023 Mar 3;13(3):e068450. doi: 10.1136/bmjopen-2022-068450.

  PMID: 36868587 DERIVED

Results Point of Contact

• Title: Prof. Shi Yuan
• Organization: Children's Hospital of Chongqing Medical University

shiyuan@hospital.cqmu.edu.cn

+86 15084335697

Study Officials

• Yuan Shi, PhD

  Children's Hospital of Chongqing Medical University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: August 1, 2022
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: July 24, 2025
• Results First Posted: January 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (3)