Respiratory distress syndrome in preterm infants Respiratory Respiratory distress syndrome of newborn
Conditions
Interventions
Volume Guarantee ventilation and Volume-Controlled ventilation
Sponsors
South Tees Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/09/2014: 1. < 34 weeks? gestation at birth 2. <24 hours old at the time of initial intubation 3. Require intubation and mechanical ventilation for respiratory distress syndrome 4. Written informed consent obtained from parents within 36 hours of initial intubation Previous inclusion criteria: 1. <34 weeks? gestation at birth 2. <24 hours old at the time of initial intubation 3. Require intubation and mechanical ventilation for respiratory distress syndrome 4. Written informed consent obtained from parents within 12 hours of initial intubation
Exclusion criteria
Exclusion criteria: 1. Do not fulfill the inclusion criteria or, 2. Require mechanical ventilation for reasons other than respiratory distress syndrome or, 3. Have a known congenital anomaly likely to adversely affect the respiratory system or life expectancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the duration (in hours) of mechanical ventilation via an endotracheal tube from study entry until achievement of the predetermined ?success? criteria. Success criteria include: 1. A mean airway pressure of <8cm H2O and a fractional inspired oxygen concentration (FiO2) =0.35 maintained for 6 consecutive hours, followed by 2. Successful completion of the spontaneous breathing test. If there is an unplanned extubation after which the infant does not require reintubation, this will also be classed as ?success? and results will be analysed on an intention to treat basis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total duration (in hours) of mechanical ventilation via an endotracheal tube until first extubation 2. Requirement for reintubation within 72 hours of extubation 3. Total duration (in hours) of mechanical ventilation via an endotracheal tube until successful extubation 4. Pulmonary air leak while receiving mechanical ventilation (including pneumothorax, pneumomediastinum, pneumopericardium, pneumatocele, and pulmonary interstitial emphysema) 5. Number of episodes of hypocarbia during mechanical ventilation (defined as carbon dioxide tension of less than 4.0 kPa) requiring adjustment of ventilation 6. Total duration (in hours) of non-invasive artificial respiratory support including nasal continuous positive airway pressure (CPAP), bilevel nasal CPAP and high flow nasal cannulae 7. Number of infants requiring rescue treatment (high frequency oscillatory ventilation) 8. Need for continuous or intermittent supplemental oxygen at a postmenstrual age of 28 days and 36 weeks? corrected gestational age 9. Bronchopulmonary dysplasia requiring home oxygen therapy or continuation of any form of respiratory support at home Mortality: 1. Death before discharge from hospital Neurological outcomes: 1. Severe intraventricular haemorrhage (grades 3 or 4 according to the Papile classification) 2. Periventricular leukomalacia Outcomes related to prematurity: 1. Retinopathy of prematurity requiring laser treatment 2. Patent ductus arteriosus requiring medical or surgical treatment 3. Necrotising enterocolitis (Bell stage 2 or greater) 4. Intestinal perforation not due to necrotising enterocolitis 5. Number of confirmed episodes of infection (positive cultures from blood and cerebr | — |
Countries
United Kingdom
Outcome results
None listed