AzTrials
AzTrials

Acute Respiratory Distress SyndromeNCT03372525

Invasive Ventilation Strategies for Neonates With Acute Respiratory Distress Syndrome Syndrome (ARDS)

A study testing HFOV and CMV in people with Acute Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 minute to 12 hours
What is being tested?
HFOV and CMV
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
1 Dec 2018to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 minute to 12 hours
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • For a neonate to be included, the following four criteria must be fulfilled: (1)gestational age (GA) between 26+0 and 32+0 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings); (2)Birth weight less than 2000g; (3) assisted with CMV within 12 h after birth; (4)diagnosis with ARDS and/or RDS. (5)stabilization before randomization within 12 h after birth: FiO2<=0.30, pH>7.20, PaCO2<=60 mmHg, Paw <=7-8 cmH2O;

Who cannot join

  • neonates with at least one of the following criteria are not eligible for the study: (1) Neonates who only needed noninvasive ventilation; (2) major congenital anomalies or chromosomal abnormalities; (3) neuromuscular diseases; (4) upper respiratory tract abnormalities; (5) need for surgery known before the first extubation; (6) Grade Ⅲ-IV-intraventricular hemorrhage (IVH); (7) congenital lung diseases or malformations or pulmonary hypoplasia.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

    Long Chen, MD, 8613883559467, neuroclong@126.com

    Shi Yuan, PhD,MD

    Recruiting

Other trials in China

About this study

Official title: Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome (ARDS) and/or RDS : a Randomized Controlled Trial

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.

Read the detailed description

Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.

Being tested
HFOV, CMV
Medical subject headings
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFOVDevice

    Infants were randomized to HFOV

  • CMVDevice

    Infants were randomized to CMV

Study groups in NCT03372525
Study groupRoleWhat they receive
HFOVExperimentalVentilated infants were randomized to HFOV.
Receives: Device: HFOV
CMVActive comparatorVentilated infants were randomized to CMV.
Receives: Device: CMV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bronchopulmonary dysplasia (BPD)

    neonate was diagnosed with BPD

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

  2. death

    the included preterm infants were dead

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

Secondary outcomes (3)

  1. air leak

    the included preterm infants were diagnosed with air leak

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

  2. the incidence of retinopathy of prematurity(ROP)

    the included preterm infants were diagnosed with ROP

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

  3. the incidence of neonatal necrotizing enterocolitis(NEC)

    the included preterm infants were diagnosed with NEC

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2017
  2. Study start1 Dec 2018
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03372525
Sponsor's protocol ID
MV for ARDS
Status last verified
Oct 2022
First submitted
9 Dec 2017
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing HFOV and CMV in people with Acute Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bronchopulmonary dysplasia (BPD) (time frame: 28 days after birth or 36 weeks'gestational age or before discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03372525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in