Nasal Continuous Positive Airway Pressure (n-CPAP) Versus Nasal Bilevel Positive Airway Pressure (n-BiPAP) for RDS
non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to compare between capap and n-bipap
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Non-invasive Ventilation for RDS: a Randomized, Cotrolled Trial to Compare CPAP by Nasal Bipap|
- Failure of extubation during the first 48 hours post-extubation [ Time Frame: during the first 48 hours post-extubation ] [ Designated as safety issue: No ]
This will be defined as:
- Uncompensated respiratory acidosis defined as pH less than 7.2 and partial pressure of carbon dioxide of more than 60 mmHg (or)
- Major apnea requiring mask ventilation
- Maintenance of successful extubation [ Time Frame: for 7 days from the hour of extubation ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: n-CPAP
The n-CPAP group will receive at extubation a single level continuous positive airway pressure of 7 cm water for at least 48 hours before weaning is commenced. If the infant is stable for the preceding 48 hours defined by having fewer than three minor apneas and no increase in oxygen requirement, weaning will be permitted.
CPAP will be decreased from 6 cm water by 1 cm water every 24 hours if tolerated based on the above criteria. This will be done until a pressure of 4 cm water is reached.
If a pressure of 4 cm water is successfully tolerated for 48 hours then time off n-CPAP will be allowed. Thereafter, no fixed weaning regime based on number of hours in a day the infant will be allowed to come off CPAP will be prescribed.
Active Comparator: n-BiPAP
The n-BiPAP group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water). Inspiratory time of one second and respiratory rate of 30/min will always be maintained.
The infant will then receive a mean airway pressure of 5 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 6 cm of water).
Active Comparator: NIPPV
o The NIPPV group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water).
The NIPPV group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water).
The primary aim of this study is to compare the impact of early extubation to nasal continuous positive airway pressure (n-CPAP) versus nasal Bilevel positive airway pressure (n-BiPAP) on the need for mechanical ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants <34 weeks' gestation requiring intubation and surfactant if indicated for respiratory distress syndrome within 60 min of delivery . Second aim is to compare different outcomes of post-extubation n-CPAP and n-BiPAP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770925
|Contact: Rania A. El-Farrash, MDfirstname.lastname@example.org|
|Contact: riham S. abd el-wahab, MBBCh|