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Completed

NCT Number: NCT02590757

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

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Key information

Conditions

Endotracheal Extubation Female Urogenital Diseases and Pregnancy Complications Infant, Premature Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

2 day–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIV-NAVA

Device

Non-invasive neurally adjusted ventilatory assist

N-CPAP

Device

Nasal-continuous positive airway pressure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Bronchopulmonary dysplasia

    Time frame: postmenstrual age 36 weeks

    Participants will be followed for the duration of hospital stay

  7. Duration of noninvasive ventilation

    Time frame: postmenstrual age 40 weeks (until discharge)

    Participants will be followed for the duration of hospital stay

  8. Duration of inspired oxygen supply

    Time frame: postmenstrual age 40 weeks (until discharge)

    Participants will be followed for the duration of hospital stay

  9. Duration of hospital stay

    Time frame: postmenstrual age 40 weeks (until discharge)

    Participants will be followed for the duration of hospital stay

  10. Adverse events

    Time frame: extubation - 3days

    Participants will be followed for 3 days after extubation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Oct 29, 2015
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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