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

NCT02996162 | Withdrawn

• 1 other identifier: IRB-P00019957
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary Dysplasia; Chronic Lung Disease; Prematurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Respiratory support

  One year

• Respiratory complications

  One year

• Non-respiratory complications

  One year

Interventions

Massimo Root Monitoring System DEVICE

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.

Also known as: Masimo Root Monitoring System and Accessories

ISA-Infrared Sidestream Gas Analyzer DEVICE

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.

Also known as: Infrared Sidestreamn gas Analyzer (ISA), Multigas Monitor

Eligibility Criteria

• Age: 3 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants with chronic lung disease of prematurity or bronchopulmonary dysplasia

You may qualify if:

• 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).

You may not qualify if:

• death prior to discharge from the NICU,
• chronic lung disease secondary to pulmonary conditions other than bronchopulmonary dysplasia and
• other underlying identified genetic syndromes.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kristen Leeman, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2020
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)