Respiratory Distress SyndromeNCT01471431
Extubation Readiness Study in Very Low Birthweight Infants
A study testing spontaneous breathing trial in people with Respiratory Distress Syndrome, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for >48 hours and have not yet been successfully extubated (extubated >7 days). Read more about this study
- Who is it for?
- Ages 48 hours to 14 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- spontaneous breathing trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Apr 2016
- 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 48 hours to 14 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birthweight >500g and<1500g.
- Postmenstrual age <34 weeks
- Mechanically ventilated >48 hours
- Never successfully extubated
Who cannot join
- Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
- Known or suspected airway anomalies
- Severe congenital malformations
- Need to remain intubated for other reasons (i.e. having surgery)
- Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Hospital of the University of Pennsylvania
Phialdelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Randomized Trial of the Spontaneous Breathing Trial to Extubate Very Low Birthweight Infants
The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for >48 hours and have not yet been successfully extubated (extubated >7 days).
- Conditions
- Respiratory Distress Syndrome
- Being tested
- spontaneous breathing trial
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spontaneous breathing trialOther
The SBT is performed daily on rounds if an infant is on conventional ventilation and meets all predetermined ventilator criteria (set ventilator rate ≤30, peak inspiratory pressure (PIP) delivered on mandatory breaths ≤20 cm H2O, pressure support (PS) ≤8 cm H2O, positive end-expiratory pressure (PEEP) ≤6 cm H2O, inspired fractional oxygen (FiO2) ≤0.40).
During the SBT, the ventilator rate and pressure support are set to zero, and the infant is maintained on continuous positive airway pressure (CPAP) alone via the endotracheal tube. The trial duration is 3 minutes, unless an infant fails before the trial is complete. Failure is defined as bradycardia <100 for >15 seconds or oxygen saturation by pulse oximetry <85% despite a 15% increase in FiO2. If an infant passes the SBT, they are extubated within 3 hours. If an infant fails the SBT, they remain intubated and the daily application of the SBT continues as long as the minimum ventilator criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous breathing trial | Experimental | The spontaneous breathing trial will determine the extubation readiness of the subject. Receives: Other: spontaneous breathing trial |
| Usual care | No intervention | Subjects will be extubated using usual care, without the use of the spontaneous breathing trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to successful extubation
The time from intubation (if >48 hours) to successful extubation (if > 7 days) as evaluated at 34 weeks postmenstrual age (gestational age + chronologic age)
Measured: 34 weeks postmenstrual age
Secondary outcomes (2)
bronchopulmonary dysplasia
The diagnosis of bronchopulmonary dysplasia will be made at 36 weeks postmenstrual age, using the traditional definition and the NIH Consensus definition.
Measured: 36 weeks postmenstrual age
extubation failure rate
The proportion of infants who fail extubation will be compared between the 2 groups.
Measured: 34 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Futility analysis by DSMC recommended termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann-Johanna Giaccone, MD, Study director, University of PennsylvaniaBarbara Schmidt, MD, MSc, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471431
- Sponsor's protocol ID
- 813859
- Status last verified
- Sep 2015
- First submitted
- 10 Nov 2011
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Spontaneous Breathing Trial to Extubate Very Low Birthweight Infants
- ClinicalTrials.gov ID
- NCT01471431
- Acronym / sponsor ID
- 813859
- Conditions
- Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility analysis by DSMC recommended termination.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Nov 2011 (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 determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for >48 hours and have not yet been successfully extubated (extubated >7 days).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing trial | Experimental | Other: spontaneous breathing trialThe spontaneous breathing trial will determine the extubation readiness of the subject. |
| Usual care | No intervention | –Subjects will be extubated using usual care, without the use of the spontaneous breathing trial. |
Who may qualify
- Ages
- 48 hours to 14 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birthweight >500g and<1500g.
- Postmenstrual age <34 weeks
- Mechanically ventilated >48 hours
- Never successfully extubated
Key exclusion criteria (5 listed)
- Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
- Known or suspected airway anomalies
- Severe congenital malformations
- Need to remain intubated for other reasons (i.e. having surgery)
- Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
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 |
|---|---|---|
| spontaneous breathing trialThe SBT is performed daily on rounds if an infant is on conventional ventilation and meets all predetermined ventilator criteria (set ventilator rate ≤30, peak inspiratory pressure (PIP) delivered on mandatory breaths ≤20 cm H2O, pressure support (PS) ≤8 cm H2O, positive end-expiratory pressure (PEEP) ≤6 cm H2O, inspired fractional oxygen (FiO2) ≤0.40). During the SBT, the ventilator rate and pressure support are set to zero, and the infant is maintained on continuous positive airway pressure (CPAP) alone via the endotracheal tube. The trial duration is 3 minutes, unless an infant fails before the trial is complete. Failure is defined as bradycardia <100 for >15 seconds or oxygen saturation by pulse oximetry <85% despite a 15% increase in FiO2. If an infant passes the SBT, they are extubated within 3 hours. If an infant fails the SBT, they remain intubated and the daily application of the SBT continues as long as the minimum ventilator criteria are met. | Other | Spontaneous breathing trial |
Primary outcome
time to successful extubation
Time frame: 34 weeks postmenstrual age
The time from intubation (if >48 hours) to successful extubation (if > 7 days) as evaluated at 34 weeks postmenstrual age (gestational age + chronologic age)
2 secondary outcomes
bronchopulmonary dysplasia
Time frame: 36 weeks postmenstrual age
extubation failure rate
Time frame: 34 weeks postmenstrual age
Results and safety
The study was stopped early (reason given: Futility analysis by DSMC recommended termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
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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.
Ann-Johanna Giaccone, MD study director
University of Pennsylvania
Barbara Schmidt, MD, MSc principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spontaneous breathing trial in people with Respiratory Distress Syndrome, run by University of Pennsylvania at 2 sites 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 5 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 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Futility analysis by DSMC recommended termination.). 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?
time to successful extubation (time frame: 34 weeks postmenstrual age). 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 7 Jun 2016.