Infant, Premature, DiseasesPhase 2NCT00308789
A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams
A Phase 2 study testing Biphasic Infant flow NCPAP and CPAP in people with Infant, Premature, Diseases and Bronchopulmonary Dysplasia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
The purpose of this study is to compare two methods of delivering Nasal Continuous Airway Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung damage. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Apnea of Prematurity
- What is being tested?
- Biphasic Infant flow NCPAP and CPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Dec 2009
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants </= 1250 grams who are going to be extubated
Who cannot join
- Congenital abnormalities of the upper airway
- Acquired nasal septum injury
- Congenital Heart Disease excluding Patent Ductus arteriosus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infant Flow Biphasic NCPAP Versus Infant Flow NCPAP for the Facilitation of Successful Extubation in Infants </= 1250 Grams: A Randomized Controlled Trial
The purpose of this study is to compare two methods of delivering Nasal Continuous Airway Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung damage.
Read the detailed description
Chronic lung disease (CLD) remains a significant problem among low birth weight infants with a reported incidence of up to 26% in infants < 1500 grams. Nasal continuous positive airway pressure (NCPAP) has been demonstrated to provide effective non-invasive respiratory support for preterm infants. The use of NCPAP is associated with a decreased need for mechanical ventilation and may impact on the incidence of CLD. There are two types of NCPAP now available, a Biphasic mode which allows for cycling at two different levels of positive pressure and a continuous mode which allows only for one level of positive pressure.
Comparisons: Biphasic NCPAP will be compared with continuous CPAP to see which better facilitates the extubation of preterm infants who weigh </= 1250 grams at birth. The incidence of CLD, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and necrotizing entercolitis will also be compared between the two groups.
- Being tested
- Biphasic Infant flow NCPAP, CPAP
- Keywords
- Continuous Positive Airway Pressure, Infant,newborn, Artificial respiration
- Medical subject headings
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic Infant flow NCPAPProcedure or surgery
Biphasic Nasal continuous positive airway pressure
CPAPProcedure or surgery
Continuous positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Biphasic NCPAP Receives: Procedure: Biphasic Infant flow NCPAP |
| 2 | Active comparator | Continuous CPAP Receives: Procedure: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful extubation with either mode of NCPAP
Measured: Day 7 post primary extubation
Secondary outcomes (3)
The incidence of chronic lung disease
The incidence of other complications of prematurity including sepsis,retinopathy of prematurity, intraventricular haemorrhage/periventricular leucomalacia and necrotizing entercolitis
The predictive value of the minute ventilation test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2008
- Study completionDec 2009 (estimated)
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Karel O'Brien, MB, FRCPC, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308789
- Sponsor's protocol ID
- 05-0258-A
- Status last verified
- May 2009
- First submitted
- 28 Mar 2006
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Brien K, Campbell C, Brown L, Wenger L, Shah V. Infant flow biphasic nasal continuous positive airway pressure (BP- NCPAP) vs. infant flow NCPAP for the facilitation of extubation in infants' </= 1,250 grams: a randomized controlled trial. BMC Pediatr. 2012 Apr 4;12:43. doi: 10.1186/1471-2431-12-43.
PubMed 22475409
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Flow Biphasic NCPAP Versus Infant Flow NCPAP for the Facilitation of Successful Extubation in Infants </= 1250 Grams: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00308789
- Acronym / sponsor ID
- 05-0258-A
- Keywords
- Continuous Positive Airway Pressure, Infant,newborn, Artificial respiration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 30 Mar 2006 (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.
The purpose of this study is to compare two methods of delivering Nasal Continuous Airway Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung damage.
Detailed description
Chronic lung disease (CLD) remains a significant problem among low birth weight infants with a reported incidence of up to 26% in infants < 1500 grams. Nasal continuous positive airway pressure (NCPAP) has been demonstrated to provide effective non-invasive respiratory support for preterm infants. The use of NCPAP is associated with a decreased need for mechanical ventilation and may impact on the incidence of CLD. There are two types of NCPAP now available, a Biphasic mode which allows for cycling at two different levels of positive pressure and a continuous mode which allows only for one level of positive pressure.
Comparisons: Biphasic NCPAP will be compared with continuous CPAP to see which better facilitates the extubation of preterm infants who weigh </= 1250 grams at birth. The incidence of CLD, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and necrotizing entercolitis will also be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Biphasic Infant flow NCPAPBiphasic NCPAP |
| 2 | Active comparator | Procedure: CPAPContinuous CPAP |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants </= 1250 grams who are going to be extubated
Key exclusion criteria (3 listed)
- Congenital abnormalities of the upper airway
- Acquired nasal septum injury
- Congenital Heart Disease excluding Patent Ductus arteriosus
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 |
|---|---|---|
| Biphasic Infant flow NCPAPBiphasic Nasal continuous positive airway pressure | Procedure or surgery | 1 |
| CPAPContinuous positive airway pressure | Procedure or surgery | 2 |
Primary outcome
The rate of successful extubation with either mode of NCPAP
Time frame: Day 7 post primary extubation
3 secondary outcomes
The incidence of chronic lung disease
The incidence of other complications of prematurity including sepsis,retinopathy of prematurity, intraventricular haemorrhage/periventricular leucomalacia and necrotizing entercolitis
The predictive value of the minute ventilation test
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
- Derived from this study: PubMed 22475409O'Brien K, Campbell C, Brown L, Wenger L, Shah V. Infant flow biphasic nasal continuous positive airway pressure (BP- NCPAP) vs. infant flow NCPAP for the facilitation of extubation in infants' </= 1,250 grams: a randomized controlled trial. BMC Pediatr. 2012 Apr 4;12:43. doi: 10.1186/1471-2431-12-43.
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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.
Karel O'Brien, MB, FRCPC principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biphasic Infant flow NCPAP and CPAP in people with Infant, Premature, Diseases and Bronchopulmonary Dysplasia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 1 inclusion and 3 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 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Poor enrollment). 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 with either mode of NCPAP (time frame: Day 7 post primary extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308789, which also lists 1 linked publication.
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 5 May 2009.