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

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ClinicalTrials.gov Identifier: NCT03372525
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Children's Hospital of Chongqing Medical University
Information provided by (Responsible Party):
Chen Long,MD, Children's Hospital of Chongqing Medical University

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Bronchopulmonary Dysplasia High Frequency Oscillation Ventilation Device: HFOV Device: CMV Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: HFOV
Ventilated infants were randomized to HFOV.
Device: HFOV
Infants were randomized to HFOV

Active Comparator: CMV
Ventilated infants were randomized to CMV.
Device: CMV
Infants were randomized to CMV




Primary Outcome Measures :
  1. bronchopulmonary dysplasia (BPD) [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    neonate was diagnosed with BPD

  2. death [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    the included preterm infants were dead


Secondary Outcome Measures :
  1. air leak [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    the included preterm infants were diagnosed with air leak

  2. the incidence of retinopathy of prematurity(ROP) [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    the included preterm infants were diagnosed with ROP

  3. the incidence of neonatal necrotizing enterocolitis(NEC) [ Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge ]
    the included preterm infants were diagnosed with NEC



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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372525


Locations
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China, Chongqing
Children's Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Long Chen, MD    8613883559467    neuroclong@126.com   
Contact: Shi Yuan, PhD,MD         
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Children's Hospital of Chongqing Medical University

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Responsible Party: Chen Long,MD, Principal Investigator, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03372525     History of Changes
Other Study ID Numbers: MV for ARDS
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Bronchopulmonary Dysplasia
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury
Ventilator-Induced Lung Injury