Bronchopulmonary DysplasiaNCT02996162
Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease
An observational study of Bronchopulmonary Dysplasia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This is a prospective, longitudinal observational study to provide data regarding the natural course of hypercapnia in premature infants with bronchopulmonary dysplasia using both available blood pCO2 and measured capnography, as well as relate the degree and trend of hypercapnia to later respiratory outcomes. Read more about this study
- Who is it for?
- Ages 3 days to 1 year
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Massimo Root Monitoring System and ISA-Infrared Sidestream Gas Analyzer
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 6 May 2021
- 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 3 days to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants with chronic lung disease of prematurity or bronchopulmonary dysplasia
Who may be able to join
- Potential eligible patients will be identified in the first 3-14 days of life at Beth Israel Deaconess Hospital (BIDMC) NICU who have a birth gestational age <=32 0/7 weeks and current or previous requirement for positive pressure (ventilation or continuous positive airway pressure (CPAP).
Who cannot join
- death prior to discharge from the NICU,
- chronic lung disease secondary to pulmonary conditions other than bronchopulmonary dysplasia and
- other underlying identified genetic syndromes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: The Natural Course of Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease
This is a prospective, longitudinal observational study to provide data regarding the natural course of hypercapnia in premature infants with bronchopulmonary dysplasia using both available blood pCO2 and measured capnography, as well as relate the degree and trend of hypercapnia to later respiratory outcomes.
Read the detailed description
Data collection will begin once an infant no longer requires mechanical ventilation, CPAP, and HFNC, up to twice per week while in the NICU. Investigators will obtain up to twenty minutes of end-tidal capnography data, using Masimo ISA modules with continuous CO2 display. Five minutes of good quality data, at approximately 30 breaths per minutes, should provide approximately 150 data points. After filtering for artifact, the mean and range of end tidal CO2 will be recorded during this interval. These recordings will be started after a feed for infants receiving enteral feeds. The capnography cannula will be placed by the bedside nurse or respiratory therapist at the conclusion of a feed and removed no later than the next feed. If data is unable to be obtained, investigators will attempt to collect it at the next regularly scheduled interval.
Available blood gases with pCO2 will also be recorded during the NICU hospitalization.
After discharge, consented subjects who are followed in the BCH outpatient pulmonary clinic will have capnography recorded at every clinic visit for a period of up to twenty minutes, and mean and range of end-tidal CO2 will be recorded after filtering for artifact. Available blood gases with pCO2 during pulmonary visits will be recorded; blood gases during sick encounters (i.e. emergency room) will be excluded. From available electronic medical record (EMR) and clinic note data, investigators will also record duration of time on respiratory support including positive pressure ventilation and nasal cannula oxygen.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Massimo Root Monitoring System, ISA-Infrared Sidestream Gas Analyzer
- Keywords
- Bronchopulmonary Dysplasia, Chronic Lung Disease, Prematurity
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massimo Root Monitoring SystemDevice
Also called Masimo Root Monitoring System and Accessories
The Masimo Root system is a patient monitoring and connectivity platform; Root displays patient monitoring information from the connected modules. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion.
ISA-Infrared Sidestream Gas AnalyzerDevice
Also called Infrared Sidestreamn gas Analyzer (ISA), Multigas Monitor
The ISA-Infrared Sidestream Gas Analyzer displays end-tidal carbon dioxide waveforms and measurements and trends of end tidal CO2. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory symptoms and complications
Primary outcome will be respiratory symptoms at one year. Respiratory symptoms will be measured by a parent-reported respiratory symptom score obtained via questionnaire.
Measured: One year
Secondary outcomes (3)
Respiratory support
Secondary outcomes will include respiratory support, including duration of need for positive pressure ventilation (number of days), duration of need for supplemental oxygen (number of days), and use of respiratory related medications (yes or no response as to whether used and percentage of use).
Measured: One year
Respiratory complications
Secondary outcome will be respiratory complications at one year. Complications will include death from respiratory cause (number of deaths), readmission for respiratory illness (number of readmissions), ICU admission (number of admissions), need for reintubation or positive pressure ventilation (number of events).
Measured: One year
Non-respiratory complications
Secondary outcomes will include non-respiratory complications such as aspiration requiring limitation of oral feeding (percentage).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start1 Dec 2020 (estimated)
- Primary completion6 May 2021
- Study completion6 May 2021
Why it stopped: The research never began; the PI has chosen to no longer pursue this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Kristen Leeman, Boston Children's Hospital
- Investigators
- Kristen Leeman, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996162
- Sponsor's protocol ID
- IRB-P00019957
- Status last verified
- Jul 2021
- First submitted
- 30 Aug 2016
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural Course of Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT02996162
- Acronym / sponsor ID
- IRB-P00019957
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary Dysplasia, Chronic Lung Disease, Prematurity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The research never began; the PI has chosen to no longer pursue this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 19 Dec 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.
This is a prospective, longitudinal observational study to provide data regarding the natural course of hypercapnia in premature infants with bronchopulmonary dysplasia using both available blood pCO2 and measured capnography, as well as relate the degree and trend of hypercapnia to later respiratory outcomes.
Detailed description
Data collection will begin once an infant no longer requires mechanical ventilation, CPAP, and HFNC, up to twice per week while in the NICU. Investigators will obtain up to twenty minutes of end-tidal capnography data, using Masimo ISA modules with continuous CO2 display. Five minutes of good quality data, at approximately 30 breaths per minutes, should provide approximately 150 data points. After filtering for artifact, the mean and range of end tidal CO2 will be recorded during this interval. These recordings will be started after a feed for infants receiving enteral feeds. The capnography cannula will be placed by the bedside nurse or respiratory therapist at the conclusion of a feed and removed no later than the next feed. If data is unable to be obtained, investigators will attempt to collect it at the next regularly scheduled interval.
Available blood gases with pCO2 will also be recorded during the NICU hospitalization.
After discharge, consented subjects who are followed in the BCH outpatient pulmonary clinic will have capnography recorded at every clinic visit for a period of up to twenty minutes, and mean and range of end-tidal CO2 will be recorded after filtering for artifact. Available blood gases with pCO2 during pulmonary visits will be recorded; blood gases during sick encounters (i.e. emergency room) will be excluded. From available electronic medical record (EMR) and clinic note data, investigators will also record duration of time on respiratory support including positive pressure ventilation and nasal cannula oxygen.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants with chronic lung disease of prematurity or bronchopulmonary dysplasia
Key inclusion criteria (1 listed)
- Potential eligible patients will be identified in the first 3-14 days of life at Beth Israel Deaconess Hospital (BIDMC) NICU who have a birth gestational age <=32 0/7 weeks and current or previous requirement for positive pressure (ventilation or continuous positive airway pressure (CPAP).
Key exclusion criteria (3 listed)
- death prior to discharge from the NICU,
- chronic lung disease secondary to pulmonary conditions other than bronchopulmonary dysplasia and
- other underlying identified genetic syndromes.
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 |
|---|---|---|
| Massimo Root Monitoring SystemAlso: Masimo Root Monitoring System and AccessoriesThe Masimo Root system is a patient monitoring and connectivity platform; Root displays patient monitoring information from the connected modules. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion. | Device | – |
| ISA-Infrared Sidestream Gas AnalyzerAlso: Infrared Sidestreamn gas Analyzer (ISA), Multigas MonitorThe ISA-Infrared Sidestream Gas Analyzer displays end-tidal carbon dioxide waveforms and measurements and trends of end tidal CO2. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion. | Device | – |
Primary outcome
Respiratory symptoms and complications
Time frame: One year
Primary outcome will be respiratory symptoms at one year. Respiratory symptoms will be measured by a parent-reported respiratory symptom score obtained via questionnaire.
3 secondary outcomes
Respiratory support
Time frame: One year
Respiratory complications
Time frame: One year
Non-respiratory complications
Time frame: One year
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 2 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Bronchopulmonary Dysplasia
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Kristen Leeman, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by Boston Children's Hospital 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 1 inclusion and 3 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 2 Aug 2021. 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?
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?
Respiratory symptoms and complications (time frame: One year). 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 2 Aug 2021.