search
Back to results

Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial (MASK)

Primary Purpose

Bronchopulmonary Dysplasia, Death

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Easy Flow system and INCA® nasal cannulae set
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring preterm infants, CPAP, BPD, invasive mechanical ventilation, we aimed determine that affect the rate of BPD and death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.

Eligibility Criteria

undefined - 1 Year (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • One hundred sixty infants born at 26-32 weeks' gestation not endotracheally intubated in the delivery room (DR)

Exclusion Criteria:

  • Infants with major congenital anomalies, and who required intubation in the DR and no parental consent were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    nasal mask and nasal prongs

    Arm Description

    Outcomes

    Primary Outcome Measures

    BPD
    To determine that affect the rate of BPD of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.

    Secondary Outcome Measures

    death
    To determine that affect the rate of death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.

    Full Information

    First Posted
    November 2, 2014
    Last Updated
    November 5, 2014
    Sponsor
    Zekai Tahir Burak Women's Health Research and Education Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02287116
    Brief Title
    Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial
    Acronym
    MASK
    Official Title
    Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zekai Tahir Burak Women's Health Research and Education Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP (nasal continuous positive airway pressure)as the initial respiratory support when using minimal ly invasive surfactant therapy (MIST) in preterm infants.
    Detailed Description
    OBJECTIVE: To determine that affect the rate of (bronchopulmonary dysplasia) BPD and death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for respiratory distress syndrome (RDS). METHODS: Inborn preterm infants of gestational age 26-32 weeks, with respiratory distress syndrome were enrolled in this single-centered, unblinded randomized prospective controlled trial. They were stabilized with T-piece device in delivery room. Immediately after admission of neonatal intensive care unit (NICU), infants were randomly assigned to receive NCPAP with either nasal prongs or mask. NCPAP was continued by setting at PEEP as 5 to 8 cm H2O . RESULTS: 160 infants were assessed for eligibility 149 infants were randomized. Finally 75 infants in Group I (nasal prong) and 74 in Group II (nasal mask) were analyzed. Mean gestational ages were 29.3±1.6 vs 29.1±2.0 weeks (p=0.55) and birth weights were 1225±257 vs. 1282±312 grams (p=0.22) respectively in Group I and Group II. The frequency of NCPAP failure within 24 hours of life was higher in Group I compared to Group 2 (respectively 8%, %0 , p=0.09) but difference was not significant. The outcomes of BPD and death rates did not differ among the groups ( Group I 9.3% vs. Group II 9.4 %; p=0.96). CONCLUSIONS: Applied nasal mask is a feasible method to deliver NCPAP and as effective as nasal prongs for the initial treatment of RDS in preterm infants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchopulmonary Dysplasia, Death
    Keywords
    preterm infants, CPAP, BPD, invasive mechanical ventilation, we aimed determine that affect the rate of BPD and death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    nasal mask and nasal prongs
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Easy Flow system and INCA® nasal cannulae set
    Primary Outcome Measure Information:
    Title
    BPD
    Description
    To determine that affect the rate of BPD of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.
    Time Frame
    7 months
    Secondary Outcome Measure Information:
    Title
    death
    Description
    To determine that affect the rate of death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.
    Time Frame
    7

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: One hundred sixty infants born at 26-32 weeks' gestation not endotracheally intubated in the delivery room (DR) Exclusion Criteria: Infants with major congenital anomalies, and who required intubation in the DR and no parental consent were excluded.

    12. IPD Sharing Statement

    Learn more about this trial

    Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial

    We'll reach out to this number within 24 hrs