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

Primary Purpose

Respiratory Insufficiency of Prematurity

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Nasal CPAP, level 7 to 9 cmH2O

Nasal CPAP, level 4 to 6 cmH2O

About this trial

This is an interventional treatment trial for Respiratory Insufficiency of Prematurity focused on measuring Respiratory distress syndrome, Preterm infants, Extubation failure, Pneumothorax, Lung injury, Airway pressure

Eligibility Criteria

undefined - 14 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Nasal CPAP, level of 7 to 9 cmH2O

Nasal CPAP, level 4 to 6 cmH2O

Outcomes

Primary Outcome Measures

The rate of successful extubation within 72 hours of extubation

Secondary Outcome Measures

The rate of successful extubation within 7 days of extubation

Number of days on nCPAP

Occurrence of air leak syndrome

Occurrence of IVH grade 3 or 4

Occurrence of traumatized nasal septum

Full Information

NCT ID

NCT00636324

First Posted

March 7, 2008

Last Updated

February 9, 2009

Sponsor

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00636324

Brief Title

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

Acronym

L-CPAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Terminated

Why Stopped

Difficulties in recruitment - will require longer time to achieve sample size

Study Start Date

July 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Insufficiency of Prematurity

Keywords

Respiratory distress syndrome, Preterm infants, Extubation failure, Pneumothorax, Lung injury, Airway pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Nasal CPAP, level of 7 to 9 cmH2O

Arm Title

Arm Type

Active Comparator

Arm Description

Nasal CPAP, level 4 to 6 cmH2O

Intervention Type

Device

Intervention Name(s)

Nasal CPAP, level 7 to 9 cmH2O

Other Intervention Name(s)

High pressure nCPAP, 7-9 cmH2O

Intervention Description

Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation

Intervention Type

Device

Intervention Name(s)

Nasal CPAP, level 4 to 6 cmH2O

Other Intervention Name(s)

Low pressure CPAP, 4-6 cmH2O

Intervention Description

Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation

Primary Outcome Measure Information:

Title

The rate of successful extubation within 72 hours of extubation

Time Frame

within 72 hours after extubation

Secondary Outcome Measure Information:

Title

The rate of successful extubation within 7 days of extubation

Time Frame