Nasal Continuous Positive Airway Pressure (n-CPAP) Versus Nasal Bilevel Positive Airway Pressure (n-BiPAP) for RDS
|ClinicalTrials.gov Identifier: NCT01770925|
Recruitment Status : Unknown
Verified January 2013 by Rania Ali El-Farrash, Ain Shams University.
Recruitment status was: Not yet recruiting
First Posted : January 18, 2013
Last Update Posted : January 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome||Device: N-CPAP Device: n-BiPAP Device: NIPPV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-invasive Ventilation for RDS: a Randomized, Cotrolled Trial to Compare CPAP by Nasal Bipap|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2014|
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).
- Failure of extubation during the first 48 hours post-extubation [ Time Frame: during the first 48 hours post-extubation ]
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770925
|Contact: Rania A. El-Farrash, MDfirstname.lastname@example.org|
|Contact: riham S. abd el-wahab, MBBCh|