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Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome (NHFOV)

Primary Purpose

Respiratory Distress Syndrome, Preterm Infant

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NHFOV
NCPAP
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring preterm infant, respiratory distress syndrome, nasal high frequence oscillation ventilation

Eligibility Criteria

30 Minutes - 1 Month (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The gestational age was less than 37 weeks;
  • These neonates were diagnosed with RDS and supported by invasive ventilation with synchronized intermittent mandatory ventilation (SIMV. The diagnosis of RDS was based on clinical manifestations and chest X-ray findings. The clinical signs and symptoms of RDS were respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. The typical X-ray picture of RDS showed a grain shadow, air bronchogram or white lung;
  • The neonates were ready to be extubated for the first time and subsequent noninvasive ventilation.

Exclusion Criteria:

  • parents' decision not to participate;
  • major congenital anomalies;
  • died or left the NICU within 24 hour.

Eligibility criteria for extubation:

Besides the improved symptoms, X-rays and sufficient spontaneous breathing efforts, the eligibility criteria for extubation were peak inspiratory pressure (PIP) of 15-20 cm H2O, positive end expiratory pressure (PEEP) of 4-6 cm H2O, respiratory rate of 15 to 30, FiO2 from 0.21 to 0.30, hematocrit more than 35%. and arterialized capillary blood gas analysis need to meet the following criteria: pH>7.20, PaCO2<=55 mmHg.

Sites / Locations

  • Department of Pediatrics, Daping Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NHFOV

NCPAP

Arm Description

NHFOV is used as the supporting mode after extubation

NCPAP is used as the supporting mode after extubation

Outcomes

Primary Outcome Measures

intubation rate
the baby was re-intubated due to respiratory failure
total time of hospitalization
the duration of baby in hospital
bronchopulmonary dysplasia(BPD)
bronchopulmonary dysplasia was diagnosed after extubation BPD was defined according to the National Institutes of Health consensus definition

Secondary Outcome Measures

airleaks
airleaks was diagnosed after extubation
Retinopathy of prematurity
Retinopathy of prematurity was diagnosed after extubation
Neonatal necrotizing enterocolitis
Neonatal necrotizing enterocolitis was diagnosed after extubation
Intraventricular hemorrhage
Intraventricular hemorrhage was diagnosed after extubation
mortality rate
the baby died in hospital
patent ductus arteriosus (PDA)
patent ductus arteriosus (PDA) was diagnosed

Full Information

First Posted
April 17, 2017
Last Updated
February 14, 2019
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03140891
Brief Title
Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome
Acronym
NHFOV
Official Title
Nasal High Frequency Oscillation Ventilation(NHFOV) vs. Nasal Continuous Positive Airway Pressure(NCPAP) as Post-extubation Respiratory Support in Preterm Infants With Respiratory Distress Syndrome:a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

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

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
In very preterm infants with severe respiratory distress syndrome(RDS), invasive ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and early/selective pulmonary surfactant administration, is one key cornerstone to reduce neonatal mortality. However, IV is related to increased risks of bronchopulmonary dysplasia (BPD) and abnormal developmental outcomes in the survival.Weaning from IV is therefore a key procedure to reducing these risks above, and if extubation does not success, repeated intubation and/or prolonged duration of IV will result in increased medical burden and intubation-associated complications and death. How to minimize the need for endotracheal ventilation and subsequent complications constitutes a challenge for neonatologists.
Detailed Description
Early weaning from invasive ventilation and avoiding re-intubation remains a focus. Nowadays, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. NCPAP is a widely used way of noninvasive ventilation strategies in preterm infants. However, there is only 60% success rate in avoiding intubation. Supplying with the combined advantages of HFOV and NCPAP with high CO2 removal, no need for synchronisation, less volume/barotraumas, non-invasion and increased functional residual capacity, nasal high frequency oscillation ventilation (NHFOV) is considered as a strengthened version of NCPAP. Thus, NHFOV may be more effective as post-extubation respiratory support to avoid re-intubation and subsequent complications/sequelae comparing with NCPAP in preterm infants. To date, NHFOV was used increasingly in neonatal intensive care unit (NICU) around the world due to its convenient operation and no consideration of synchronisation, and several small studies have reported the beneficial effects of NHFOV in preterm infants. However, there were rare randomized controlled studies compared NHFOV with NCPAP as post-extubation respiratory support strategies in preterm infants. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support on the need for endotracheal ventilation and subsequent complications in preterm infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Preterm Infant
Keywords
preterm infant, respiratory distress syndrome, nasal high frequence oscillation ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NHFOV
Arm Type
Experimental
Arm Description
NHFOV is used as the supporting mode after extubation
Arm Title
NCPAP
Arm Type
Active Comparator
Arm Description
NCPAP is used as the supporting mode after extubation
Intervention Type
Device
Intervention Name(s)
NHFOV
Intervention Description
NHFOV is used as the noninvasive mode after extubation
Intervention Type
Device
Intervention Name(s)
NCPAP
Intervention Description
NCPAP is used as the noninvasive mode after extubation
Primary Outcome Measure Information:
Title
intubation rate
Description
the baby was re-intubated due to respiratory failure
Time Frame
3 days
Title
total time of hospitalization
Description
the duration of baby in hospital
Time Frame
100 days
Title
bronchopulmonary dysplasia(BPD)
Description
bronchopulmonary dysplasia was diagnosed after extubation BPD was defined according to the National Institutes of Health consensus definition
Time Frame
at 28 days after birth or 36 weeks'gestational age or at discharge
Secondary Outcome Measure Information:
Title
airleaks
Description
airleaks was diagnosed after extubation
Time Frame
3 days
Title
Retinopathy of prematurity
Description
Retinopathy of prematurity was diagnosed after extubation
Time Frame
100 days
Title
Neonatal necrotizing enterocolitis
Description
Neonatal necrotizing enterocolitis was diagnosed after extubation
Time Frame
3 days
Title
Intraventricular hemorrhage
Description
Intraventricular hemorrhage was diagnosed after extubation
Time Frame
3 days
Title
mortality rate
Description
the baby died in hospital
Time Frame
100 days
Title
patent ductus arteriosus (PDA)
Description
patent ductus arteriosus (PDA) was diagnosed
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The gestational age was less than 37 weeks; These neonates were diagnosed with RDS and supported by invasive ventilation with synchronized intermittent mandatory ventilation (SIMV. The diagnosis of RDS was based on clinical manifestations and chest X-ray findings. The clinical signs and symptoms of RDS were respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. The typical X-ray picture of RDS showed a grain shadow, air bronchogram or white lung; The neonates were ready to be extubated for the first time and subsequent noninvasive ventilation. Exclusion Criteria: parents' decision not to participate; major congenital anomalies; died or left the NICU within 24 hour. Eligibility criteria for extubation: Besides the improved symptoms, X-rays and sufficient spontaneous breathing efforts, the eligibility criteria for extubation were peak inspiratory pressure (PIP) of 15-20 cm H2O, positive end expiratory pressure (PEEP) of 4-6 cm H2O, respiratory rate of 15 to 30, FiO2 from 0.21 to 0.30, hematocrit more than 35%. and arterialized capillary blood gas analysis need to meet the following criteria: pH>7.20, PaCO2<=55 mmHg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD,MD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Pediatrics, Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
30955572
Citation
Chen L, Wang L, Ma J, Feng Z, Li J, Shi Y. Nasal High-Frequency Oscillatory Ventilation in Preterm Infants With Respiratory Distress Syndrome and ARDS After Extubation: A Randomized Controlled Trial. Chest. 2019 Apr;155(4):740-748. doi: 10.1016/j.chest.2019.01.014.
Results Reference
derived

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Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome

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