Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
Primary Purpose
Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation, Nasal Continuous Positive Airway Pressure
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NHFOV
NCPAP
Sponsored by
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia
Eligibility Criteria
Inclusion Criteria:
Eligibility requirements for neonates:
- The gestational age is less than 32 weeks
- The preterm neonates are diagnosed with BPD and need invasive ventilation
- Extubation and subsequent noninvasive ventilation is ready to be carried out
Exclusion Criteria:
one of the following conditions is needed:
- there were no intraventricular hemorrhage(IVH) grades 3 or 4
- major congenital anomalies
- parents' decision not to participate
Sites / Locations
- Chen(陈)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NHFOV
NCPAP
Arm Description
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
Outcomes
Primary Outcome Measures
re-intubation rate
the newborn infants with ventilated BPD is reintubated after extubation
death
the newborn infants with BPD die
the level of carbon dioxide
the level of carbon dioxide is measure after extubation between groups
Secondary Outcome Measures
necrotizing entercolitis(NEC)
the newborn infants with BPD is diagnosed with NEC
intraventricular hemorrhage(IVH)
the newborn infants with BPD is diagnosed with NEC
Full Information
NCT ID
NCT04905732
First Posted
February 26, 2021
Last Updated
October 13, 2022
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborators
Children's Hospital of Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04905732
Brief Title
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
Official Title
Nasal High-frequency Oscillatory Ventilation (NHFOV) vs Nasal Continuous Positive Airway Pressure(NCPAP) for Ventilated Newborn Infants With BPD: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborators
Children's Hospital of Chongqing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS). However, it is also related to increased risks of ventilator-associated lung injury and escalation of pulmonary inflammation, and which finally result in bronchopulmonary dysplasia (BPD). Early weaning from IV in newborn infants with BPD is therefore a key procedure to reduce these risks above.
Detailed Description
Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.
We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation, Nasal Continuous Positive Airway Pressure, Neonate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After documenting parental consent, the ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP
Masking
InvestigatorOutcomes Assessor
Masking Description
After documenting parental consent, these ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP using a table of random numbers and sealed opaque envelopes when they were eligible for extubation. Blinding to doctor was not possible due to the nature of the intervention, is not necessary to participant.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NHFOV
Arm Type
Experimental
Arm Description
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
Arm Title
NCPAP
Arm Type
Active Comparator
Arm Description
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
Intervention Type
Device
Intervention Name(s)
NHFOV
Intervention Description
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
Intervention Type
Device
Intervention Name(s)
NCPAP
Intervention Description
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
Primary Outcome Measure Information:
Title
re-intubation rate
Description
the newborn infants with ventilated BPD is reintubated after extubation
Time Frame
seven days after extubation
Title
death
Description
the newborn infants with BPD die
Time Frame
seven days after extubation
Title
the level of carbon dioxide
Description
the level of carbon dioxide is measure after extubation between groups
Time Frame
seven days after extubation
Secondary Outcome Measure Information:
Title
necrotizing entercolitis(NEC)
Description
the newborn infants with BPD is diagnosed with NEC
Time Frame
seven days after extubation
Title
intraventricular hemorrhage(IVH)
Description
the newborn infants with BPD is diagnosed with NEC
Time Frame
seven days after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligibility requirements for neonates:
The gestational age is less than 32 weeks
The preterm neonates are diagnosed with BPD and need invasive ventilation
Extubation and subsequent noninvasive ventilation is ready to be carried out
Exclusion Criteria:
one of the following conditions is needed:
there were no intraventricular hemorrhage(IVH) grades 3 or 4
major congenital anomalies
parents' decision not to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen(陈) Long, MD, PhD
Phone
+8613883559467
Email
neuroclong@126.com
Facility Information:
Facility Name
Chen(陈)
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen(陈) Long, MD,PhD
Phone
+8613883559467
Email
neuroclong@126.com
12. IPD Sharing Statement
Learn more about this trial
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
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