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

Phase 2

Terminated

• Conditions: Respiratory Insufficiency of Prematurity
• Interventions: Device: Nasal CPAP, level 7 to 9 cmH2O; Device: Nasal CPAP, level 4 to 6 cmH2O

• Registration Number: NCT00636324
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-09
• Last Update Posted: 2009-02-10
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nasal CPAP, level 7 to 9 cmH2O	Nasal CPAP, level of 7 to 9 cmH2O
2	Nasal CPAP, level 4 to 6 cmH2O	Nasal CPAP, level 4 to 6 cmH2O

Primary Outcome Measures

Name	Time	Method
The rate of successful extubation within 72 hours of extubation	within 72 hours after extubation

Secondary Outcome Measures

Name	Time	Method
The rate of successful extubation within 7 days of extubation	within 14 days after extubation
Number of days on nCPAP	within 14 days after extubation
Occurrence of air leak syndrome	within 14 days after extubation
Occurrence of IVH grade 3 or 4	within 14 days after extubation
Occurrence of traumatized nasal septum	within 14 days after extubation