Elective High Frequency Oscillatory Ventilation (HFOV) Versus Conventional Mechanical Ventilation(CMV) for Acute Respiratory Distress Syndrome(ARDS) and/or Respiratory Distress Syndrome(RDS) in Neonates:a Multicenter Randomized Trial

  • STATUS
    Recruiting
  • End date
    Dec 12, 2024
  • participants needed
    646
  • sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Updated on 21 October 2022
acute respiratory distress
FIO2
pulmonary surfactant
high frequency oscillatory ventilation
assisted breathing
assisted ventilation
respiratory disease

Summary

Neonatal respiratory distress syndrome (RDS) remains a major respiratory disorder for the increasing preterm population, and its incidence has been confirmed to be increased gradually with decreased gestational age. Previous studies demonstrated incidences of 90% at 24 weeks', 80% at 28 weeks', 57% at 30-31 weeks', and 25% at 35-36 weeks' gestational age(GA). However, these figures were mainly performed in the pre-neonatal acute respiratory distress syndrome (ARDS) era, in which ARDS was usually considered as RDS, and surfactant was therefore used repeatedly. In fact, no studies have indicated beneficial effects of surfactant for adult and pediatric ARDS, and therefore, its exact action for neonatal ARDS was needed to be further elucidated. In 2017, the international ARDS collaborative group provided the first consensus definition for neonatal ARDS, and the exact incidence of neonatal ARDS and mortality were unknown.

Description

Similarities to adult and pediatric ARDS, no special pharmacologic therapy for neonatal ARDS has been shown to reduce either short-term or long-term mortality and morbidity, the risk of death therefore remains high for preterm infants. Study reported that 50% chance of death with neonatal intensive care appeared at 24 weeks in most high-income countries and 34 in low-income and middle-income countries. Among the survivors, bronchopulmonary dysplasia(BPD), neurologic impairment and retinopathy of prematurity(ROP) were the main causes of secondary death, rehospitalization and medical resource use. How to reduce rate of mortality and severe complications constitutes a challenge for neonatologists.

An interesting result was that HFOV did reduce the incidence of mortality as compared with CMV(2:9 vs 3:3, 95%confidence intervel(CI) 0.09-0.89, P=0.03) (4:177 vs 13:179, 95%CI 0.10-0.94, P=0.04). The results suggested that, excluding preterm infants with RDS, HFOV could also reduce other primary outcomes, such as the risk of death, BPD, IVH and neurologic impairment.

Details
Condition Respiratory Distress Syndrome, Acute Respiratory Distress Syndrome, High Frequency Oscillatory Ventilation
Treatment CMV, Selective HFOV
Clinical Study IdentifierNCT03736707
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

subgroup 1: For a neonate to be included, the following four criteria must be
fulfilled
gestational age (GA) between 26+0 and 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings)
birth weight less than 2000g
diagnosis with ARDS and/or RDS
assisted with CMV within 12 h after birth
stabilization before randomization within 12 h after birth: FiO2<0.40, Paw<12 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg(these may be evaluated by arterial blood gas analysis)
subgroup 2 For a neonate to be included, the following four criteria must be
fulfilled
gestational age (GA) more than 33+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings)
birth weight more than 2000g
diagnosis with ARDS and/or RDS
assisted with CMV within 12 h after birth
stabilization before randomization within 12 h after birth: FiO2<0.40, Paw<12 cmH2O, 90%-95% of SpO2, pH>7.20, PaCO2<60 mmHg(these may be evaluated by arterial blood gas analysis)

Exclusion Criteria

Neonates with at least one of the following criteria are not eligible for the
study
neonates who only needed noninvasive ventilation
major congenital anomalies or chromosomal abnormalities
neuromuscular diseases
upper respiratory tract abnormalities
need for surgery known before the first extubation
grade Ⅲ-IV-intraventricular hemorrhage (IVH)
congenital lung diseases or malformations or pulmonary hypoplasia
parents reject to join
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note