Spontaneous Breathing TestNCT01953562
Positioning and the Spontaneous Breathing Test in Neonates
An observational study of Spontaneous Breathing Test and Infants, run by Christiana Care Health Services.
Trial summary
The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur: 1. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Spontaneous Breathing Test, Infants, NICU
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jul 2014
- Phase
- Observational
- 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
Study population: Intubated infants who qualify for the routine spontaneous breathing test.
Who may be able to join
- Infants who qualify for SBT as part of their normal care
Who cannot join
- Previous history of abdominal or chest surgery (i.e. chest tube, PDA ligation, surgical NEC)
- Congenital malformation of the chest of abdomen
- Neuromuscular disorder
- Current medications affecting neuromuscular tone (ex morphine)
- Unable to be positioned either prone or supine as determined by the attending neonatologist.
About this study
Official title: Evaluation of the Influence of Positioning and Time Duration on the Spontaneous Breathing Test in Neonates
The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur:
- work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP).
- Performing the SBT in the prone position, in addition to the routine position (supine).
- Conditions
- Spontaneous Breathing Test, Infants, NICU
- Keywords
- infants, NICU, intubated, ventilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intubated infants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test
SBT is a pass/fail test. The effect of prone vs supine positioning in intubated neonates on whether a spontaneous breathing test is scored pass or fail will be determined.
Measured: 30 minutes
Secondary outcomes (1)
WOB indices during SBT
Determination whether prone vs supine position alters the work of breathing indices in infants while receiving a SBT
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: This protocol was closed and will be redesigned and submitted as a new protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Breathing TestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Locke, Christiana Care Health Services
- Investigators
- Robert Locke, DO, MPH, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953562
- Sponsor's protocol ID
- CCC#33186
- Status last verified
- Aug 2016
- First submitted
- 24 Sep 2013
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Positioning and Time Duration on the Spontaneous Breathing Test in Neonates
- ClinicalTrials.gov ID
- NCT01953562
- Acronym / sponsor ID
- CCC#33186
- Conditions
- Spontaneous Breathing Test, Infants, NICU
- Keywords
- infants, NICU, intubated, ventilator
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This protocol was closed and will be redesigned and submitted as a new protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Oct 2013 (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 spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur:
- work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP).
- Performing the SBT in the prone position, in addition to the routine position (supine).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated infants | – | – |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Intubated infants who qualify for the routine spontaneous breathing test.
Key inclusion criteria (1 listed)
- Infants who qualify for SBT as part of their normal care
Key exclusion criteria (5 listed)
- Previous history of abdominal or chest surgery (i.e. chest tube, PDA ligation, surgical NEC)
- Congenital malformation of the chest of abdomen
- Neuromuscular disorder
- Current medications affecting neuromuscular tone (ex morphine)
- Unable to be positioned either prone or supine as determined by the attending neonatologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test
Time frame: 30 minutes
SBT is a pass/fail test. The effect of prone vs supine positioning in intubated neonates on whether a spontaneous breathing test is scored pass or fail will be determined.
1 secondary outcome
WOB indices during SBT
Time frame: 10 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
Robert Locke, DO, MPH principal investigator
Christiana Care Health Services
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Breathing Test and Infants, run by Christiana Care Health Services.
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 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: withdrawn, as of the sponsor's last update on 9 Aug 2016. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test (time frame: 30 minutes). 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 9 Aug 2016.