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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02287116
Acronym
MASK
Enrollment
150
Registered
2014-11-10
Start date
2014-05-31
Completion date
2014-10-31
Last updated
2014-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

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.

Interventions

DEVICEEasy Flow system and INCA® nasal cannulae set

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
BPD7 monthsTo determine that affect the rate of BPD of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.

Secondary

MeasureTime frameDescription
death7To determine that affect the rate of death of NCPAP therapy with nasal prongs or nasal mask as the initial treatment for RDS.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026