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

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ClinicalTrials.gov Identifier: NCT00636324
Recruitment Status : Terminated (Difficulties in recruitment - will require longer time to achieve sample size)
First Posted : March 14, 2008
Last Update Posted : February 10, 2009
Sponsor:
Information provided by:
McMaster University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency of Prematurity Device: Nasal CPAP, level 7 to 9 cmH2O Device: Nasal CPAP, level 4 to 6 cmH2O Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure
Study Start Date : July 2007
Actual Primary Completion Date : March 2008
Estimated Study Completion Date : June 2010

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Arms and Interventions
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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 Name: 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 Name: Low pressure CPAP, 4-6 cmH2O


Outcome Measures
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Primary Outcome Measures :
  1. The rate of successful extubation within 72 hours of extubation [ Time Frame: within 72 hours after extubation ]

Secondary Outcome Measures :
  1. The rate of successful extubation within 7 days of extubation [ Time Frame: within 14 days after extubation ]
  2. Number of days on nCPAP [ Time Frame: within 14 days after extubation ]
  3. Occurrence of air leak syndrome [ Time Frame: within 14 days after extubation ]
  4. Occurrence of IVH grade 3 or 4 [ Time Frame: within 14 days after extubation ]
  5. Occurrence of traumatized nasal septum [ Time Frame: within 14 days after extubation ]

Eligibility Criteria
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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636324


Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Giulherme M SantAnna, MD Hamilton Health Sciences Corporation
More Information
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Responsible Party: Guilherme Mendes Sant'Anna, Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00636324     History of Changes
Other Study ID Numbers: REB project # 07-047
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009
Keywords provided by McMaster University:
Respiratory distress syndrome
Preterm infants
Extubation failure
 Pneumothorax
Lung injury
Airway pressure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases