surfactant administration via laryngeal mask airway versus endotracheal tube in severe neonatal respiratory distress syndrome

Not Applicable

Conditions: Respiratory distress syndrome of newborn.
Hyaline membrane disease

Registration Number: IRCT201602019568N14

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

Inclusion Criteria

born at less than 37 gestational weeks, weighed = 1200 grams, had a diagnosis of RDS within the first two hours of life, requiring continuous positive airway pressure (CPAP) support = 5cm H2O (with or without nasal intermittent positive pressure ventilation (PPV)), plus fraction of inspired oxygen (FiO2) between 30 - 60% to maintain blood oxygen saturation (SpO2) between 88 to 95%

Exclusion criteria: having a previous intubation, major malformations (craniofacial, cardiac or thoracic), mean arterial pressure (MAP) < 40 mmHg, Apgar score = 3 at 5 minutes, requiring FiO2 concentrations > 60%, pneumothorax prior to enrollment, apnea requiring assisted ventilation, diaphragmatic hernia, and parents’ refusal to give informed consent.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The requirement for mechanical ventilation. Timepoint: One hour after surfactant treatment. Method of measurement: PH<7.15, PCO2>60, PO2<50 on the Arterial blood gas analysis.

Secondary Outcome Measures

Name	Time	Method
Requirement for a second dose of surfactant. Timepoint: eight hours after surfactant administration. Method of measurement: Redosing was considered if FiO2 was = 60% or if FiO2 was = 30% associated with worsening of RDS clinical signs.;Reduced needed FiO2 to maintain adequate oxygenation. Timepoint: Before and one hour after surfactant therapy. Method of measurement: Determination of needed Fio2 in blender and by pulse oxymetry.