Respiratory Insufficiency of PrematurityPhase 2L-CPAPNCT00636324
Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)
A Phase 2 study testing Nasal CPAP, level 7 to 9 cmH2O and Nasal CPAP, level 4 to 6 cmH2O in people with Respiratory Insufficiency of Prematurity, run by Hamilton Health Sciences Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Respiratory Insufficiency of Prematurity
- What is being tested?
- Nasal CPAP, level 7 to 9 cmH2O and Nasal CPAP, level 4 to 6 cmH2O
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight 500 - 1,250 g
- On mechanical ventilation before 7 days of age
- First extubation before 14 days of age
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Insufficiency of Prematurity
- Being tested
- Nasal CPAP, level 7 to 9 cmH2O, Nasal CPAP, level 4 to 6 cmH2O
- Keywords
- Respiratory distress syndrome, Preterm infants, Extubation failure, Pneumothorax, Lung injury, Airway pressure
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome, Pneumothorax, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal CPAP, level 7 to 9 cmH2ODevice
Also called High pressure nCPAP, 7-9 cmH2O
Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation
Nasal CPAP, level 4 to 6 cmH2ODevice
Also called Low pressure CPAP, 4-6 cmH2O
Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nasal CPAP, level of 7 to 9 cmH2O Receives: Device: Nasal CPAP, level 7 to 9 cmH2O |
| 2 | Active comparator | Nasal CPAP, level 4 to 6 cmH2O Receives: Device: Nasal CPAP, level 4 to 6 cmH2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful extubation within 72 hours of extubation
Measured: within 72 hours after extubation
Secondary outcomes (5)
The rate of successful extubation within 7 days of extubation
Measured: within 14 days after extubation
Number of days on nCPAP
Measured: within 14 days after extubation
Occurrence of air leak syndrome
Measured: within 14 days after extubation
Occurrence of IVH grade 3 or 4
Measured: within 14 days after extubation
Occurrence of traumatized nasal septum
Measured: within 14 days after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionJun 2010 (estimated)
Why it stopped: Difficulties in recruitment - will require longer time to achieve sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Giulherme M SantAnna, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636324
- Sponsor's protocol ID
- REB project # 07-047
- Acronym
- L-CPAP
- Status last verified
- Feb 2009
- First submitted
- 7 Mar 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure
- ClinicalTrials.gov ID
- NCT00636324
- Acronym / sponsor ID
- L-CPAP / REB project # 07-047
- Conditions
- Respiratory Insufficiency of Prematurity
- Keywords
- Respiratory distress syndrome, Preterm infants, Extubation failure, Pneumothorax, Lung injury, Airway pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruitment - will require longer time to achieve sample size
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Nasal CPAP, level 7 to 9 cmH2ONasal CPAP, level of 7 to 9 cmH2O |
| 2 | Active comparator | Device: Nasal CPAP, level 4 to 6 cmH2ONasal CPAP, level 4 to 6 cmH2O |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birth weight 500 - 1,250 g
- On mechanical ventilation before 7 days of age
- First extubation before 14 days of age
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal CPAP, level 7 to 9 cmH2OAlso: High pressure nCPAP, 7-9 cmH2OApply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation | Device | 1 |
| Nasal CPAP, level 4 to 6 cmH2OAlso: Low pressure CPAP, 4-6 cmH2OApply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation | Device | 2 |
Primary outcome
The rate of successful extubation within 72 hours of extubation
Time frame: within 72 hours after extubation
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Difficulties in recruitment - will require longer time to achieve sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulherme M SantAnna, MD principal investigator
Hamilton Health Sciences Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nasal CPAP, level 7 to 9 cmH2O and Nasal CPAP, level 4 to 6 cmH2O in people with Respiratory Insufficiency of Prematurity, run by Hamilton Health Sciences Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruitment - will require longer time to achieve sample size). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful extubation within 72 hours of extubation (time frame: within 72 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2009.