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

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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

, ,

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