Respiratory Insufficiency of Prematurity Clinical Trial
Official title:
Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure
Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its application remain. Clinical indications vary greatly between institutions, especially when combined with varieties of systems, devices, and techniques available. One of the controversial aspects that needs to be clarified is the level of pressure which should be used. The objective of the study is to compare the effectiveness of two ranges of nCPAP pressure that are within the spectrum of current practice for post-extubation support in very preterm infants.
The use of nCPAP has been established as an effective respiratory support to prevent
extubation failure and as treatment of other pulmonary diseases. An upsurge in its
popularity has resulted in some controversial aspects, including the level of pressure to be
used. The level that has been used in very preterm infants after extubation, which mostly
came from anecdotal data, varies from 3 to 10 cmH2O.
Physiologic studies show higher nCPAP pressures improve lung mechanical properties. Though
potential side effects have been of concern in practical application, there is no formal
evidence supporting the concept that increased CPAP pressure results in a higher risk of
complications. In relatively stable preterm infants, the range of optimal CPAP level needs
to be established in order to adequately support the upper airway and lungs, without
increasing complications secondary to the pressure applied. Given the uncertainty of the
nCPAP pressure that should be used in very preterm infants, we conduct a randomized
controlled trial to compare the effectiveness of two ranges of nCPAP pressure for
post-extubation support in very preterm infants.
The purpose of this trial is to compare the rate of successful extubation of using the nasal
CPAP level of 7 to 9 cmH2O compared to level of 4 to 6 cmH2O.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00637169 -
Canadian Oxygen Trial (COT)
|
Phase 3 | |
| Completed |
NCT00433212 -
Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)
|
Phase 3 |