- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03736707
Selective High Frequency Oscillatory Ventilation (HFOV) for Neonates
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chongqing
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Chongqing, Chongqing, China, 400042
- Children's Hospital of Chongqing Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Selective HFOV
Selective HFOV will be provided
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Selective HFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase
|
Active Comparator: CMV
CMV will be provided
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CMV was delivered by time-cycled, pressure-limited ventilators
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death
Time Frame: 36 weeks' gestational age
|
the included neonates were dead
|
36 weeks' gestational age
|
the incidence of extracorporeal membrane oxygenation(ECMO) for neonates in group 2
Time Frame: 36 weeks' gestational age
|
the included neonates need to being supported by ECMO
|
36 weeks' gestational age
|
the incidence of bronchopulmonary dysplasia(BPD)
Time Frame: 36 weeks' gestational age
|
the included neonates were diagnosed with BPD
|
36 weeks' gestational age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of retinopathy of prematurity(ROP)
Time Frame: 36 weeks' gestational age
|
the included neonates were diagnosed with ROP
|
36 weeks' gestational age
|
the incidence of necrotizing enterocolitis(NEC)
Time Frame: 36 weeks' gestational age
|
the included neonates were diagnosed with NEC
|
36 weeks' gestational age
|
duration of invasive ventilation
Time Frame: 36 weeks' gestational age
|
duration of invasive ventilation for HFOV or CMV
|
36 weeks' gestational age
|
air leak (pneumothorax and/or pneumomediastinum) occurred
Time Frame: 36 weeks' gestational age
|
the included neonates were diagnosed with air leak
|
36 weeks' gestational age
|
intraventricular hemorrhage(IVH)>2nd grade
Time Frame: 36 weeks' gestational age
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the included neonates were diagnosed with IVH>2nd grade
|
36 weeks' gestational age
|
composite mortality/BPD
Time Frame: 36 weeks' gestational age
|
the included neonates were diagnosed with composite mortality/BPD
|
36 weeks' gestational age
|
the success rate of extubation
Time Frame: 36 weeks' gestational age
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the included neonates wean from invasive ventilation
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36 weeks' gestational age
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NARDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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