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

February 9, 2009 updated by: Hamilton Health Sciences Corporation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Nasal CPAP, level of 7 to 9 cmH2O
Device: Nasal CPAP, level 7 to 9 cmH2O
Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation
Other Names:
  • High pressure nCPAP, 7-9 cmH2O
Active Comparator: 2
Nasal CPAP, level 4 to 6 cmH2O
Device: Nasal CPAP, level 4 to 6 cmH2O
Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation
Other Names:
  • Low pressure CPAP, 4-6 cmH2O

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of successful extubation within 72 hours of extubation
Time Frame: within 72 hours after extubation
within 72 hours after extubation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Giulherme M SantAnna, MD, Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2009

Last Update Submitted That Met QC Criteria

February 9, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB project # 07-047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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