Bronchopulmonary DysplasiaNCT01440647
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
A study testing Extubation to NIPPV and Extubation to CPAP in people with Bronchopulmonary Dysplasia, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Extubation to NIPPV and Extubation to CPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria.
- Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life.
- Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz.
- Infants who have never been previously extubated.
Who cannot join
- Infants enrolled in competing trials.
- Participation refused by parent/attending physician/ parent unavailable for consent.
- Infants with any major congenital abnormality.
- Postoperative patients from any surgery.
- Infants in extremis/decided upon not to receive intensive care.
- Ventilator settings lower than the intervention group.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital of RI
Providence, Rhode Island, 02905
About this study
Official title: Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Extubation to NIPPV, Extubation to CPAP
- Keywords
- Respiration, Artificial, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure, Non-Invasive Positive-Pressure Ventilation, Intermittent Positive-Pressure Ventilation, High-Frequency Ventilation
- Medical subject headings
- Bronchopulmonary Dysplasia, Respiratory Aspiration, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extubation to NIPPVProcedure or surgery
Also called NIPPV
After extubation infants were placed on NIPPV as soon as all the extubation criteria were met
Extubation to CPAPProcedure or surgery
Also called CPAP
After extubation infants were placed on CPAP
| Study group | Role | What they receive |
|---|---|---|
| NIPPV | Experimental | Extubation to NIPPV (nasal intermittent positive pressure ventilation) Receives: Procedure: Extubation to NIPPV |
| CPAP | Active comparator | After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life Receives: Procedure: Extubation to CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Being Intubated
Measured: 30 days from birth
Secondary outcomes (1)
Percentage of Participants With Reintubation
Reintubation rate is a measure of the efficacy of NIPPV.
Measured: 0-7 days post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Sorina, Women and Infants Hospital of Rhode Island
- Investigators
- Olga A DeSimone, MD, Principal investigator, The Floating Hospital for Children at Tufts Medical CenterAbbot R Laptook, MD, Study director, Women and Infants Hospital of RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440647
- Sponsor's protocol ID
- 07-0090
- Status last verified
- Feb 2013
- First submitted
- 22 Sep 2011
- Last updated
- 12 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study
- ClinicalTrials.gov ID
- NCT01440647
- Acronym / sponsor ID
- 07-0090
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Respiration, Artificial, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure, Non-Invasive Positive-Pressure Ventilation, Intermittent Positive-Pressure Ventilation, High-Frequency Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Posted 12 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIPPV | Experimental | Procedure: Extubation to NIPPVExtubation to NIPPV (nasal intermittent positive pressure ventilation) |
| CPAP | Active comparator | Procedure: Extubation to CPAPAfter extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria.
- Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life.
- Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz.
- Infants who have never been previously extubated.
Key exclusion criteria (6 listed)
- Infants enrolled in competing trials.
- Participation refused by parent/attending physician/ parent unavailable for consent.
- Infants with any major congenital abnormality.
- Postoperative patients from any surgery.
- Infants in extremis/decided upon not to receive intensive care.
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 |
|---|---|---|
| Extubation to NIPPVAlso: NIPPVAfter extubation infants were placed on NIPPV as soon as all the extubation criteria were met | Procedure or surgery | NIPPV |
| Extubation to CPAPAlso: CPAPAfter extubation infants were placed on CPAP | Procedure or surgery | CPAP |
Primary outcome
Number of Days Being Intubated
Time frame: 30 days from birth
1 secondary outcome
Percentage of Participants With Reintubation
Time frame: 0-7 days post-extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bronchopulmonary Dysplasia
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Recruiting
Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
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.
Olga A DeSimone, MD principal investigator
The Floating Hospital for Children at Tufts Medical Center
Abbot R Laptook, MD study director
Women and Infants Hospital of RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extubation to NIPPV and Extubation to CPAP in people with Bronchopulmonary Dysplasia, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
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 12 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days Being Intubated (time frame: 30 days from birth). 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 12 Mar 2013.