Brief Title
Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease
Official Title
The Natural Course of Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease
Brief 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.
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 Type
Observational
Primary Outcome
Respiratory symptoms and complications
Secondary Outcome
Respiratory support
Condition
Bronchopulmonary Dysplasia
Intervention
Massimo Root Monitoring System
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
40
Start Date
December 1, 2020
Completion Date
June 1, 2022
Primary Completion Date
January 1, 2022
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
1. death prior to discharge from the NICU,
2. chronic lung disease secondary to pulmonary conditions other than bronchopulmonary
dysplasia and
3. other underlying identified genetic syndromes.
Gender
All
Ages
N/A - 1 Year
Accepts Healthy Volunteers
No
Contacts
Kristen Leeman, MD, 617-355-5709, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02996162
Organization ID
IRB-P00019957
Responsible Party
Principal Investigator
Study Sponsor
Boston Children's Hospital
Collaborators
Beth Israel Deaconess Medical Center
Study Sponsor
Kristen Leeman, MD, Principal Investigator, Boston Children's Hospital
Verification Date
October 2020