Abstract
Background:
Some studies have suggested that the early sustained lung inflation (SLI) procedure is effective in decreasing the need for mechanical ventilation (MV) and improving respiratory outcome in preterm infants. We planned the present randomized controlled trial to confirm or refute these findings.
Methods/design:
In this study, 276 infants born at 25(+0) to 28(+6) weeks' gestation at high risk of respiratory distress syndrome (RDS) will be randomized to receive the SLI maneuver (25 cmH2O for 15 seconds) followed by nasal continuous positive airway pressure (NCPAP) or NCPAP alone in the delivery room. SLI and NCPAP will be delivered using a neonatal mask and a T-piece ventilator.The primary endpoint is the need for MV in the first 72 hours of life. The secondary endpoints include the need and duration of respiratory support (NCPAP, MV and surfactant), and the occurrence of bronchopulmonary dysplasia (BPD).
Trial registration number:
NCT01440868.
Publication types
-
Multicenter Study
-
Randomized Controlled Trial
-
Research Support, Non-U.S. Gov't
MeSH terms
-
Bronchopulmonary Dysplasia / etiology
-
Bronchopulmonary Dysplasia / physiopathology
-
Bronchopulmonary Dysplasia / prevention & control
-
Clinical Protocols
-
Continuous Positive Airway Pressure
-
Delivery Rooms*
-
Functional Residual Capacity
-
Gestational Age
-
Humans
-
Infant, Extremely Premature*
-
Infant, Newborn
-
Italy
-
Lung / physiopathology*
-
Positive-Pressure Respiration / adverse effects
-
Positive-Pressure Respiration / methods*
-
Pulmonary Surfactants / therapeutic use
-
Research Design*
-
Respiratory Distress Syndrome, Newborn / diagnosis
-
Respiratory Distress Syndrome, Newborn / etiology
-
Respiratory Distress Syndrome, Newborn / physiopathology
-
Respiratory Distress Syndrome, Newborn / prevention & control*
-
Risk Assessment
-
Risk Factors
-
Time Factors
-
Treatment Outcome
Supplementary concepts
-
Respiratory Distress Syndrome In Premature Infants
Associated data
-
ClinicalTrials.gov/NCT01440868