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

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Easy Flow system and INCA® nasal cannulae set

Device

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

Time frame: 7

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

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Acronym: MASK

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Nov 10, 2014
Registry last updated: Nov 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed