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Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

Primary Purpose

Nasal High Frequency Oscillation Ventilation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
noninvasive high-frequency ventilation (nHFOV)
nasal continuous positive airway pressure (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 Nasal High Frequency Oscillation Ventilation

Eligibility Criteria

30 Minutes - 6 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Gestational age (GA) is from 26 to 37 weeks;
  2. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
  3. Respiratory distress syndrome Silverman score >5;
  4. Informed parental consent has been obtained.

Exclusion Criteria:

  1. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7;
  2. Major congenital malformations or complex congenital heart disease;
  3. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
  4. Cardiopulmonary arrest needing prolonged resuscitation;
  5. transferred out of the neonatal intensive care unit without treatment.

Sites / Locations

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nHFOV

nCPAP

Arm Description

noninvasive high-frequency ventilation (nHFOV) is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome

nasal continuous positive airway pressure (nCPAP) is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome

Outcomes

Primary Outcome Measures

intubation
the baby is re-intubated.

Secondary Outcome Measures

Bronchopulmonary dysplasia(BPD)
BPD was defined according to the National Institutes of Health consensus definition
Bayley Scales of Infant Development
scores of Bayley Scales of Infant Development at 2 months old and 2 years old

Full Information

First Posted
June 26, 2017
Last Updated
October 23, 2022
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
NCT03206489
Brief Title
Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants
Official Title
Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Preterm Twins Infants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 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

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
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome
Detailed Description
Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of noninvasive high frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal High Frequency Oscillation Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) are used as primary mode of ventilation in preterm twins infants with RDS
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nHFOV
Arm Type
Experimental
Arm Description
noninvasive high-frequency ventilation (nHFOV) is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
Arm Title
nCPAP
Arm Type
Active Comparator
Arm Description
nasal continuous positive airway pressure (nCPAP) is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome
Intervention Type
Device
Intervention Name(s)
noninvasive high-frequency ventilation (nHFOV)
Intervention Description
noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome
Intervention Type
Device
Intervention Name(s)
nasal continuous positive airway pressure (nCPAP)
Intervention Description
nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome
Primary Outcome Measure Information:
Title
intubation
Description
the baby is re-intubated.
Time Frame
during the first 7 days after birth
Secondary Outcome Measure Information:
Title
Bronchopulmonary dysplasia(BPD)
Description
BPD was defined according to the National Institutes of Health consensus definition
Time Frame
at a post-menstrual age of 36 weeks or at discharge
Title
Bayley Scales of Infant Development
Description
scores of Bayley Scales of Infant Development at 2 months old and 2 years old
Time Frame
30 months after birth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age (GA) is from 26 to 37 weeks; Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings; Respiratory distress syndrome Silverman score >5; Informed parental consent has been obtained. Exclusion Criteria: Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7; Major congenital malformations or complex congenital heart disease; Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; Cardiopulmonary arrest needing prolonged resuscitation; transferred out of the neonatal intensive care unit without treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Long, MD
Phone
13883559467
Ext
86
Email
476679422@qq.com
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
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Long, PhD,MD
Phone
13508300283
Email
petshi530@vip.163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

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