Extubation FailureNCT00979433
Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants
A study testing Bubble CPAP and Conventional CPAP in people with Extubation Failure, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Extubation Failure
- What is being tested?
- Bubble CPAP and Conventional CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2007to Nov 2009
- Phase
- Interventional
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestation less than 32 weeks
- Birth weight less than 1500 g
- Age less than seven days
- First extubation attempt.
Who cannot join
- A neonate having any of the following will be excluded from the study-
- Severe birth asphyxia defined as need for chest compression for more than 30 seconds
- Suspected congenital neuromuscular disorder
- Major congenital malformation
- Grade 3/4 interventricular haemorrhage
- Hydrops.
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi
About this study
Official title: Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial
The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.
Read the detailed description
There have been no published randomized trials comparing extubation failure rates of Bubble CPAP with conventional ventilator derived CPAP. Infants of gestation <32 weeks and of birth weight less than 1500 grams considered by the treating team to be ready for the initial extubation within first week of life were screened for enrolment. All eligible neonates were randomly allocated to bubble CPAP or conventional CPAP.The purpose of this study is to compare whether infants on Bubble CPAP had more chances of successful extubation as compared to infants put on Conventional CPAP.
- Conditions
- Extubation Failure
- Being tested
- Bubble CPAP, Conventional CPAP
- Keywords
- Extubation failure, Continuous positive airway pressure, Bubble CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble CPAPDevice
Also called Fisher & Paykel Bubble CPAP System
Bubble CPAP will be delivered using Fischer \& Paykel CPAP system with a starting flow of 6 liters/minute. CPAP will be initially started at a pressure of 5 - 6 cm H2O and fraction of inspired oxygen (FiO2) of 0.4 - 0.5. which will be adjusted to maintain oxygen saturation (SpO2) between 87 and 93%.
Conventional CPAPDevice
Conventional CPAP will be delivered using Argyle CPAP (Sherwood Medical Company, Mexico) short nasal prongs with warm, humidified gas used (34-37°C) through a thermo-statically controlled humidifier, flow @ 4-8 L/min from either SLE 2000 pressure-controlled continuous flow ventilator (Specialized Laboratory Equipment, UK) or Baby log 8000 volume guarantee ventilator.
| Study group | Role | What they receive |
|---|---|---|
| Bubble CPAP | Experimental | All neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life. Receives: Device: Bubble CPAP |
| Conventional CPAP | Other | All neonates randomly allocated to conventional/ventilator derived CPAP. Receives: Device: Conventional CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure - defined as need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation
Measured: Till 72 hours after extubation
Secondary outcomes (1)
Time to extubation failure in hours.
Measured: till extubation failure within first 72 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startSep 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation FailureStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramesh K Agarwal, All India Institute of Medical Sciences
- Investigators
- Vinod K Paul, MD PhD, Study chair, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiSucheta Yadav, MBBS, Principal investigator, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiMari J Sankar, MD, DM, Study chair, Department of Pediatrics, All India Institute of Medical Sciences, New DelhiRamesh Agarwal, MD, DM, Study chair, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979433
- Sponsor's protocol ID
- A-74
- Status last verified
- Feb 2013
- First submitted
- 17 Sep 2009
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bubble CPAP vs. Conventional CPAP Following Extubation in Preterm Very Low Birth Weight (VLBW) Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00979433
- Acronym / sponsor ID
- A-74
- Conditions
- Extubation Failure
- Keywords
- Extubation failure, Continuous positive airway pressure, Bubble CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Sep 2009 (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 objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.
Detailed description
There have been no published randomized trials comparing extubation failure rates of Bubble CPAP with conventional ventilator derived CPAP. Infants of gestation <32 weeks and of birth weight less than 1500 grams considered by the treating team to be ready for the initial extubation within first week of life were screened for enrolment. All eligible neonates were randomly allocated to bubble CPAP or conventional CPAP.The purpose of this study is to compare whether infants on Bubble CPAP had more chances of successful extubation as compared to infants put on Conventional CPAP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bubble CPAP | Experimental | Device: Bubble CPAPAll neonates randomised to bubble CPAP will be put on Bubble CPAP following initial extubation in first week of life. |
| Conventional CPAP | Other | Device: Conventional CPAPAll neonates randomly allocated to conventional/ventilator derived CPAP. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestation less than 32 weeks
- Birth weight less than 1500 g
- Age less than seven days
- First extubation attempt.
Key exclusion criteria (6 listed)
- A neonate having any of the following will be excluded from the study-
- Severe birth asphyxia defined as need for chest compression for more than 30 seconds
- Suspected congenital neuromuscular disorder
- Major congenital malformation
- Grade 3/4 interventricular haemorrhage
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 |
|---|---|---|
| Bubble CPAPAlso: Fisher & Paykel Bubble CPAP SystemBubble CPAP will be delivered using Fischer \& Paykel CPAP system with a starting flow of 6 liters/minute. CPAP will be initially started at a pressure of 5 - 6 cm H2O and fraction of inspired oxygen (FiO2) of 0.4 - 0.5. which will be adjusted to maintain oxygen saturation (SpO2) between 87 and 93%. | Device | Bubble CPAP |
| Conventional CPAPConventional CPAP will be delivered using Argyle CPAP (Sherwood Medical Company, Mexico) short nasal prongs with warm, humidified gas used (34-37°C) through a thermo-statically controlled humidifier, flow @ 4-8 L/min from either SLE 2000 pressure-controlled continuous flow ventilator (Specialized Laboratory Equipment, UK) or Baby log 8000 volume guarantee ventilator. | Device | Conventional CPAP |
Primary outcome
Extubation failure - defined as need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation
Time frame: Till 72 hours after extubation
1 secondary outcome
Time to extubation failure in hours.
Time frame: till extubation failure within first 72 hours after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
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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.
Vinod K Paul, MD PhD study chair
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Sucheta Yadav, MBBS principal investigator
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
Mari J Sankar, MD, DM study chair
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bubble CPAP and Conventional CPAP in people with Extubation Failure, run by All India Institute of Medical Sciences at 1 site in India.
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 4 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: finished, as of the sponsor's last update on 26 Feb 2013. 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 India. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Extubation failure - defined as need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation (time frame: Till 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 26 Feb 2013.