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

NCT ID: NCT02287116

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Bronchopulmonary Dysplasia Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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nasal mask and nasal prongs

Group Type NO_INTERVENTION

Easy Flow system and INCA® nasal cannulae set

Intervention Type DEVICE

Interventions

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Easy Flow system and INCA® nasal cannulae set

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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birgul say

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BS197455

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BIRBILYA

Identifier Type: -

Identifier Source: org_study_id