Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease

Bronchopulmonary Dysplasia Clinical Trial

Official title:

The Natural Course of Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02996162
• Other study ID #: IRB-P00019957
• Status: Withdrawn
• Start date: December 1, 2020
• Est. completion date: May 6, 2021

Study information

• Verified date: July 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hypercapnia
• Lung Diseases

Intervention

Device:
• Massimo Root Monitoring System
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 Analyzer
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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Secondary	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).	One year
Secondary	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).	One year
Secondary	Non-respiratory complications	Secondary outcomes will include non-respiratory complications such as aspiration requiring limitation of oral feeding (percentage).	One year