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
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
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
NCT ID
NCT02287116
First Posted
November 2, 2014
Last Updated
November 5, 2014
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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
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