NCT03591796

Brief Summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
6.5 years until next milestone

Study Start

First participant enrolled

December 31, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 9, 2025

Status Verified

October 1, 2022

Enrollment Period

Same day

First QC Date

July 9, 2018

Last Update Submit

July 3, 2025

Conditions

Acute Respiratory Distress SyndromeConventional Mechanical VentilationHigh Frequency Oscillation Ventilation

Outcome Measures

Primary Outcomes (2)

  • the incidence of bronchopulmonary dysplasia (BPD)

    the included neonate was diagnosed with BPD

    28 days after birth or 36 weeks'gestational age

  • Death

    the included preterm infants were dead

    28 days after birth or 36 weeks'gestational age or before discharge

Secondary Outcomes (5)

  • the incidence of neonatal necrotizing enterocolitis(NEC)

    28 days after birth or 36 weeks'gestational age or before discharge

  • the incidence of retinopathy of prematurity(ROP)

    28 days after birth or 36 weeks'gestational age or before discharge

  • Intraventricular hemorrhage

    28 days after birth or 36 weeks'gestational age or before discharge

  • composite mortality/BPD

    28 days after birth or 36 weeks'gestational age or before discharge

  • the incidence of airleak

    28 days after birth or 36 weeks'gestational age or before discharge

Study Arms (2)

HFOV

EXPERIMENTAL

Ventilated infants were randomized to HFOV.

Device: HFOV

CMV

ACTIVE COMPARATOR

Ventilated infants were randomized to CMV.

Device: CMV

Interventions

HFOVDEVICE

Ventilated infants were randomized to HFOV

HFOV
CMVDEVICE

Ventilated infants were randomized to CMV.

CMV

Eligibility Criteria

Age1 Minute - 12 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age (GA) between 25+0 and 34+0 weeks;
  • Assisted with CMV within 12 h after birth;
  • Diagnosis with ARDS;
  • Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH \> 7.20, PaCO2 60 mmHg and \> 35% of hematocrit

You may not qualify if:

  • parents' decision not to participate;
  • Major congenital anomalies or chromosomal abnormalities;
  • Upper respiratory tract abnormalities;
  • need for surgery before randomization;
  • Grade â…¢-IV-intraventricular hemorrhage (IVH).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

December 31, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 9, 2025

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
after accepted
Access Criteria
email to the corresponding author
More information

Locations

CN(1)