Respiratory Distress Syndrome, NewbornNCT02835209
Positioning During SBT in NICU Infants
An observational study of Respiratory Distress Syndrome, Newborn and Ventilator-associated Lung Injury, run by Christiana Care Health Services.
Trial summary
Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. Read more about this study
- Who is it for?
- Ages 24 to 34 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Ventilator-associated Lung Injury
- What is being tested?
- Work of breathing during SBT
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Sep 2018
- 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 24 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants who are mechanically ventilated.
Who may be able to join
- Infants born 24+0 to 34+6 weeks gestation
- Intubated for a minimum of 24hrs
- Qualify for an SBT as standard of care.
Who cannot join
- Previous history of abdominal or chest surgery
- Congenital malformation of the chest or abdomen
- Neuromuscular disorder
- Current medications affecting neuro-muscular tone
- Unable to be positioned either prone, supine or lateral as determined by the attending neonatologist.
About this study
Official title: Effect of Position on the Spontaneous Breathing Trial
Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. In contrast, discontinuation of mechanical ventilation during recovery remains largely subjective. A potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT). The efficacy of SBT or other tests used in older patient populations in improving clinical judgment is questionable in the neonatal population with its unique physiology, respiratory mechanics and drive factors. Christiana Care Health System NICU currently uses the SBT as a standard part of neonatal assessment for extubation from mechanical ventilation.
Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine, lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT. An SBT performed in one position may not predict infant respiratory status after extubation in another position. Understanding the impact of infant positioning and work of breathing indices independently or in combination with an SBT will aid clinicians in decision-making and potentially decrease neonatal morbidity (inaccuracy with timing and safety of extubation). This pilot study will begin to explore these clinically relevant factors.
Objectives: This pilot study will investigate the (1) role of infant position on SBT score and (2) the relationship of work of breathing indices in reference to the SBT score and infant position.
Read the detailed description
Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. In contrast, discontinuation of mechanical ventilation during recovery remains largely subjective. Typically 25% of infants weighing <1500g who are extubated using these criteria require reintubation suggesting that the ability of clinicians to predict successful extubation is limited. A potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT). The efficacy of SBT or other tests used in older patient populations in improving clinical judgment is questionable in the neonatal population with its unique physiology, respiratory mechanics and drive factors.
Christiana Care Health System NICU currently uses the SBT as a standard part of neonatal assessment for extubation from mechanical ventilation.
The SBT used at CCHS is a non-invasive 5-minute test performed on an intubated infant. Respiratory rates (RR), expired tidal volume (Vte), heart rate, and oxygen saturation by pulse oximetry (SpO2) are recorded. An SBT is considered passed, when there is no apnea (defined as no respiratory effort for greater than 20 seconds), no bradycardia (defined as heart rate less than 100 for greater than 15 seconds), and the SpO2 has been maintained at greater than 85% or SBT VE greater than 60% than that of the mechanical VE.
Potentially confounding the SBT, and unstudied, is the effect of position (prone, supine, lateral). Similar to adults, infant position has a significant effect on the efficacy of spontaneous breathing. Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine, lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT. An SBT performed in one position may not predict infant respiratory status after extubation in another position. Understanding the impact of infant positioning and work of breathing indices independently or in combination with an SBT will aid clinicians in decision-making and potentially decrease neonatal morbidity (inaccuracy with timing and safety of extubation). This pilot study will begin to explore these clinically relevant factors.
Work of breathing (WOB) indices can be non-invasively measured utilizing respiratory inductive plethysmography (RIP). WOB indices measured by RIP have been utilized by this research team for clinical and research purposes, including at CCHS. RIP entails that an infant breathe calmly while wearing soft elastic cloth bands that comfortably encircle the rib cage and abdomen. Contained within the bands is a flexible sinusoidal wire that measures motion. Measurements are taken for a minimum of 10 breaths, but preferable throughout the duration of the 5 minutes SBT.
Objectives: This pilot study will investigate the (1) role of infant position on SBT score and (2) the relationship of work of breathing indices in reference to the SBT score and infant position.
- Being tested
- Work of breathing during SBT
- Keywords
- spontaneous breathing test, premature infant, work of breathing
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Work of breathing during SBTOther
Pulmonary function tests and work of breathing indices will be collected during the spontaneous breathing test.
| Study group | Role | What they receive |
|---|---|---|
| Work of breathing during SBT | Ventilated premature infants born 24 to 34+6 weeks gestational age. Receives: Other: Work of breathing during SBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of infant positioning on spontaneous breathing test (SBT) pass rates
SBT will be performed with the infant in 3 different positions (supine, prone, side-lying).
Measured: Less than 1 hour
Impact of infant positioning on spontaneous breathing test (SBT) fail rates
SBT will be performed with the infant in 3 different positions (supine, prone, side-lying)
Measured: Less than 1 hour
Secondary outcomes (2)
WOB correlates of SBT pass rates
Pulmonary function tests will be performed during the SBT in each position (supine, prone and side-lying).
Measured: Less than 1 hour
WOB correlates of SBT fail rates
Pulmonary function tests will be performed during the SBT in each position (supine, prone and side-lying).
Measured: Less than 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startNov 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: Change in clinical practice that logistically prevented this study from being engaged.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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
- Sponsor
- Investigators
- Robert Locke, DO, MPH, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835209
- Sponsor's protocol ID
- DDD#603398
- Status last verified
- Feb 2018
- First submitted
- 8 Jun 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data would be shared in a data warehouse after a data use agreement was in place.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Position on the Spontaneous Breathing Trial
- ClinicalTrials.gov ID
- NCT02835209
- Acronym / sponsor ID
- DDD#603398
- Keywords
- spontaneous breathing test, premature infant, work of breathing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change in clinical practice that logistically prevented this study from being engaged.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 18 Jul 2016 (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.
Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. In contrast, discontinuation of mechanical ventilation during recovery remains largely subjective. A potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT). The efficacy of SBT or other tests used in older patient populations in improving clinical judgment is questionable in the neonatal population with its unique physiology, respiratory mechanics and drive factors. Christiana Care Health System NICU currently uses the SBT as a standard part of neonatal assessment for extubation from mechanical ventilation.
Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine, lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT. An SBT performed in one position may not predict infant respiratory status after extubation in another position. Understanding the impact of infant positioning and work of breathing indices independently or in combination with an SBT will aid clinicians in decision-making and potentially decrease neonatal morbidity (inaccuracy with timing and safety of extubation). This pilot study will begin to explore these clinically relevant factors.
Objectives: This pilot study will investigate the (1) role of infant position on SBT score and (2) the relationship of work of breathing indices in reference to the SBT score and infant position.
Detailed description
Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. In contrast, discontinuation of mechanical ventilation during recovery remains largely subjective. Typically 25% of infants weighing <1500g who are extubated using these criteria require reintubation suggesting that the ability of clinicians to predict successful extubation is limited. A potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT). The efficacy of SBT or other tests used in older patient populations in improving clinical judgment is questionable in the neonatal population with its unique physiology, respiratory mechanics and drive factors.
Christiana Care Health System NICU currently uses the SBT as a standard part of neonatal assessment for extubation from mechanical ventilation.
The SBT used at CCHS is a non-invasive 5-minute test performed on an intubated infant. Respiratory rates (RR), expired tidal volume (Vte), heart rate, and oxygen saturation by pulse oximetry (SpO2) are recorded. An SBT is considered passed, when there is no apnea (defined as no respiratory effort for greater than 20 seconds), no bradycardia (defined as heart rate less than 100 for greater than 15 seconds), and the SpO2 has been maintained at greater than 85% or SBT VE greater than 60% than that of the mechanical VE.
Potentially confounding the SBT, and unstudied, is the effect of position (prone, supine, lateral). Similar to adults, infant position has a significant effect on the efficacy of spontaneous breathing. Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine, lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT. An SBT performed in one position may not predict infant respiratory status after extubation in another position. Understanding the impact of infant positioning and work of breathing indices independently or in combination with an SBT will aid clinicians in decision-making and potentially decrease neonatal morbidity (inaccuracy with timing and safety of extubation). This pilot study will begin to explore these clinically relevant factors.
Work of breathing (WOB) indices can be non-invasively measured utilizing respiratory inductive plethysmography (RIP). WOB indices measured by RIP have been utilized by this research team for clinical and research purposes, including at CCHS. RIP entails that an infant breathe calmly while wearing soft elastic cloth bands that comfortably encircle the rib cage and abdomen. Contained within the bands is a flexible sinusoidal wire that measures motion. Measurements are taken for a minimum of 10 breaths, but preferable throughout the duration of the 5 minutes SBT.
Objectives: This pilot study will investigate the (1) role of infant position on SBT score and (2) the relationship of work of breathing indices in reference to the SBT score and infant position.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Work of breathing during SBT | – | Other: Work of breathing during SBTVentilated premature infants born 24 to 34+6 weeks gestational age. |
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants who are mechanically ventilated.
Key inclusion criteria (3 listed)
- Infants born 24+0 to 34+6 weeks gestation
- Intubated for a minimum of 24hrs
- Qualify for an SBT as standard of care.
Key exclusion criteria (5 listed)
- Previous history of abdominal or chest surgery
- Congenital malformation of the chest or abdomen
- Neuromuscular disorder
- Current medications affecting neuro-muscular tone
- Unable to be positioned either prone, supine or lateral 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Work of breathing during SBTPulmonary function tests and work of breathing indices will be collected during the spontaneous breathing test. | Other | Work of breathing during SBT |
Primary outcome
Impact of infant positioning on spontaneous breathing test (SBT) pass rates
Time frame: Less than 1 hour
SBT will be performed with the infant in 3 different positions (supine, prone, side-lying).
Impact of infant positioning on spontaneous breathing test (SBT) fail rates
Time frame: Less than 1 hour
SBT will be performed with the infant in 3 different positions (supine, prone, side-lying)
2 secondary outcomes
WOB correlates of SBT pass rates
Time frame: Less than 1 hour
WOB correlates of SBT fail rates
Time frame: Less than 1 hour
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 5 Feb 2018.
- Individual participant dataSharing planned: Yes. De-identified data would be shared in a data warehouse after a data use agreement was in place.
Related trials for Respiratory Distress Syndrome, Newborn
Not yet recruitingObservational study
Early Switch in Moderate ARDS
Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingPhase 2
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Acute Respiratory Distress Syndrome, ARDS
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 Respiratory Distress Syndrome, Newborn and Ventilator-associated Lung Injury, 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 3 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 5 Feb 2018. 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?
Impact of infant positioning on spontaneous breathing test (SBT) pass rates (time frame: Less than 1 hour). The study lists 2 primary outcomes in all. 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 5 Feb 2018.