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

NCT ID: NCT02996162

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-05-06

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.

Conditions

Bronchopulmonary Dysplasia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Masimo Root Monitoring System and Accessories; Infrared Sidestreamn gas Analyzer (ISA); Multigas Monitor

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.

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristen Leeman

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen Leeman, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-P00019957

Identifier Type: -

Identifier Source: org_study_id