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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Device: Massimo Root Monitoring System; Device: ISA-Infrared Sidestream Gas Analyzer

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

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature infants with chronic lung disease of prematurity or bronchopulmonary dysplasia

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Non-respiratory complications	Secondary outcomes will include non-respiratory complications such as aspiration requiring limitation of oral feeding (percentage).	One year

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Kristen Leeman, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Prematurity; Chronic Lung Disease; Bronchopulmonary Dysplasia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Lung Diseases; Bronchopulmonary Dysplasia; Hypercapnia
• Other Study ID Numbers: IRB-P00019957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO