Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study

December 5, 2021 updated by: Han-Suk Kim, Seoul National University Hospital

Comparison of Non-invasive Ventilation Neurally Adjusted Ventilatory Assist vs. Nasal Continuous Positive Airway Pressure After Extubation in Infants' < 30 Weeks of Gestation: Randomized Controlled Study

This study is a randomized controlled study to compare if a a non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure (N-CPAP) after extubation in infants' < 30 weeks of gestation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • postconceptional age less than 30+0 weeks
  • infants who fulfill the the criteria for extubation for 6 hours extubation criteria: Ventilator rate ≤ 25 breaths/min, Peak inspiratory pressure (PIP) ≤ 16cmH2O, Fractional inspired oxygen (FiO2) ≤ 0.3

Exclusion Criteria:

  • conditions which will decrease life expectancy
  • major anomalies which will decrease life expectancy
  • any anomalous conditions which involve upper and lower airway
  • neuromuscular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NIV-NAVA
Noninvasive ventilation in this group is practiced with NIV-NAVA
Device: NIV-NAVA
Non-invasive neurally adjusted ventilatory assist
Active Comparator: N-CPAP
Patients in this group will receive nasal continuous positive airway pressure as routinely in neonatal intensive care unit.
Device: N-CPAP
Nasal-continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation failure
Time Frame: extubation - 72 hours

Failure criteria

  • pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings
  • Severe apnea event requiring bag and mask resuscitation
  • FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
  • Frequent desaturations (< 85%) ≥ 3/hr not responding to increased ventilatory settings or an increase in Fio2 to 1.0
extubation - 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
Time Frame: extubation - 72 hours
Participants will be followed for the extubation failure within 3 days after extubation
extubation - 72 hours
Severe apnea event requiring bag and mask resuscitation
Time Frame: extubation - 72 hours
Participants will be followed for the extubation failure within 3 days after extubation
extubation - 72 hours
FiO2 >0.6 to maintain SpO2 ≥ 88% after extubation
Time Frame: extubation - 7 days
Participants will be followed for the extubation failure within 7 days after extubation
extubation - 7 days
pH < 7.2 with pCO2 > 70mmHg confirmed by capillary blood gas analysis in spite of maximum settings
Time Frame: extubation - 7 days
Participants will be followed for the extubation failure within 7 days after extubation
extubation - 7 days
Severe apnea event requiring bag and mask resuscitation
Time Frame: extubation - 7 days
Participants will be followed for the extubation failure within 7 days after extubation
extubation - 7 days
Bronchopulmonary dysplasia
Time Frame: postmenstrual age 36 weeks
Participants will be followed for the duration of hospital stay
postmenstrual age 36 weeks
Duration of noninvasive ventilation
Time Frame: postmenstrual age 40 weeks (until discharge)
Participants will be followed for the duration of hospital stay
postmenstrual age 40 weeks (until discharge)
Duration of inspired oxygen supply
Time Frame: postmenstrual age 40 weeks (until discharge)
Participants will be followed for the duration of hospital stay
postmenstrual age 40 weeks (until discharge)
Duration of hospital stay
Time Frame: postmenstrual age 40 weeks (until discharge)
Participants will be followed for the duration of hospital stay
postmenstrual age 40 weeks (until discharge)
Adverse events
Time Frame: extubation - 3days
Participants will be followed for 3 days after extubation
extubation - 3days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2015

Primary Completion (Actual)

November 13, 2020

Study Completion (Actual)

January 23, 2021

Study Registration Dates

First Submitted

October 25, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 5, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-1917

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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