Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)

Respiratory Insufficiency of Prematurity Clinical Trial

— L-CPAP  

Official title:

Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00636324
• Other study ID #: REB project # 07-047
• Status: Terminated
• Phase: Phase 2
• First received: March 7, 2008
• Last updated: February 9, 2009
• Start date: July 2007
• Est. completion date: June 2010

Study information

• Verified date: February 2009
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

• Birth weight 500 - 1,250 g

• On mechanical ventilation before 7 days of age

• First extubation before 14 days of age

Exclusion Criteria:

• Presence of lethal anomalies or upper airway abnormalities

• IVH, grade 3 or 4

• Neuromuscular disorders

• Receiving muscle relaxation at time of extubation

• Congenital heart disease, except for PDA

• GI problems resulting in a need to avoid gastric distension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Respiratory Insufficiency of Prematurity

Intervention

Device:
• Nasal CPAP, level 7 to 9 cmH2O
Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation
• Nasal CPAP, level 4 to 6 cmH2O
Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful extubation within 72 hours of extubation		within 72 hours after extubation	No
Secondary	The rate of successful extubation within 7 days of extubation		within 14 days after extubation	Yes
Secondary	Number of days on nCPAP		within 14 days after extubation	Yes
Secondary	Occurrence of air leak syndrome		within 14 days after extubation	Yes
Secondary	Occurrence of IVH grade 3 or 4		within 14 days after extubation	Yes
Secondary	Occurrence of traumatized nasal septum		within 14 days after extubation	Yes