Volume Guarantee or Volume-Controlled ventilatio
- Conditions
- Respiratory distress syndrome in preterm infantsRespiratoryRespiratory distress syndrome of newborn
- Registration Number
- ISRCTN04448562
- Lead Sponsor
- South Tees Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 113
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br> Success criteria include:<br> 1. A mean airway pressure of <8cm H2O and a fractional inspired oxygen concentration (FiO2) =0.35 maintained for 6 consecutive hours, followed by<br> 2. Successful completion of the spontaneous breathing test.<br><br> 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.<br>
- Secondary Outcome Measures
Name Time Method