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

This study has been terminated.
(Difficulties in recruitment - will require longer time to achieve sample size)
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00636324
First received: March 7, 2008
Last updated: February 9, 2009
Last verified: February 2009
  Purpose

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 Intervention Phase
Respiratory Insufficiency of Prematurity
Device: Nasal CPAP, level 7 to 9 cmH2O
Device: Nasal CPAP, level 4 to 6 cmH2O
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • The rate of successful extubation within 72 hours of extubation [ Time Frame: within 72 hours after extubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of successful extubation within 7 days of extubation [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]
  • Number of days on nCPAP [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]
  • Occurrence of air leak syndrome [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]
  • Occurrence of IVH grade 3 or 4 [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]
  • Occurrence of traumatized nasal septum [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: July 2007
Estimated Study Completion Date: June 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636324

Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Giulherme M SantAnna, MD Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Guilherme Mendes Sant'Anna, Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00636324     History of Changes
Other Study ID Numbers: REB project # 07-047
Study First Received: March 7, 2008
Last Updated: February 9, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Respiratory distress syndrome
Preterm infants
Extubation failure
Pneumothorax
Lung injury
Airway pressure

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014