Brief Title
Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial
Official Title
Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial
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.
Study Type
Interventional
Primary Outcome
BPD
Secondary Outcome
death
Condition
Bronchopulmonary Dysplasia
Intervention
Easy Flow system and INCA® nasal cannulae set
Study Arms / Comparison Groups
nasal mask and nasal prongs
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
150
Start Date
May 2014
Completion Date
October 2014
Primary Completion Date
May 2014
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.
Gender
All
Ages
N/A - 1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Administrative Informations
NCT ID
NCT02287116
Organization ID
BIRBILYA
Secondary IDs
BS197455
Responsible Party
Principal Investigator
Study Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Study Sponsor
, ,
Verification Date
November 2014