Skip to main content
Clinical Trials/NCT02287116
NCT02287116
Completed
Not Applicable

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

Zekai Tahir Burak Women's Health Research and Education Hospital0 sites150 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchopulmonary Dysplasia
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Enrollment
150
Primary Endpoint
BPD
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
October 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Responsible Party
Principal Investigator
Principal Investigator

birgul say

CONTINUOUS POSITIVE AIRWAY PRESSURE VIA BINASAL PRONG VS NASAL MASK: A RANDOMISED CONTROLLED TRIAL

Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Outcomes

Primary Outcomes

BPD

Time Frame: 7 months

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

Secondary Outcomes

  • death(7)

Similar Trials