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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

Tracking Information
First Submitted Date  ICMJE March 7, 2008
First Posted Date  ICMJE March 14, 2008
Last Update Posted Date February 10, 2009
Study Start Date  ICMJE July 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
The rate of successful extubation within 72 hours of extubation [ Time Frame: within 72 hours after extubation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00636324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
  • The rate of successful extubation within 7 days of extubation [ Time Frame: within 14 days after extubation ]
  • Number of days on nCPAP [ Time Frame: within 14 days after extubation ]
  • Occurrence of air leak syndrome [ Time Frame: within 14 days after extubation ]
  • Occurrence of IVH grade 3 or 4 [ Time Frame: within 14 days after extubation ]
  • Occurrence of traumatized nasal septum [ Time Frame: within 14 days after extubation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)
Official Title  ICMJE Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Insufficiency of Prematurity
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Nasal CPAP, level of 7 to 9 cmH2O
    Intervention: Device: Nasal CPAP, level 7 to 9 cmH2O
  • Active Comparator: 2
    Nasal CPAP, level 4 to 6 cmH2O
    Intervention: Device: Nasal CPAP, level 4 to 6 cmH2O
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 9, 2009)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2008)
180
Estimated Study Completion Date  ICMJE June 2010
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00636324
Other Study ID Numbers  ICMJE REB project # 07-047
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guilherme Mendes Sant'Anna, Hamilton Health Sciences
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giulherme M SantAnna, MD Hamilton Health Sciences Corporation
PRS Account McMaster University
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP