Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

NCT03154112 | Completed DMC

• 1 other identifier: IRB-P00025365
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming. Currently, there is no device which measures either oxygen consumption, or another variable that depends on oxygen consumption - resting energy expenditure - in neonates or infants. Our group has developed a new device which can attach to any ventilator and measures these two variables with accuracy in the preclinical setting, including in rodents as small as severely preterm infants. The purpose of this study is to compare measurements of oxygen consumption and energy expenditure in neonates using this device and comparing it with a gold standard which is rarely used, a Douglas bag method in which expired gas is collected and later analyzed.

Conditions

Neonatal Respiratory Failure; Congenital Heart Defect

Outcome Measures

Primary Outcomes (4)

• Oxygen consumption

  1 hour

• Carbon dioxide production

  1 hour

• Respiratory quotient

  1 hour

• Resting energy expenditure

  1 hour

Interventions

Measurement of oxygen consumption and caloric expenditure DEVICE

This study will involve an \~1 hour, single point in time measurement of oxygen consumption, carbon dioxide production, resting energy expenditure, and respiratory quotient using two methods while patients are breathing an FiO2 of 40%. These measurements will be measured using the novel, responsive device and compared with gas collected simultaneously collected from a Douglas bag.

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from inpatients in the neonatal or cardiac intensive care unit who are mechanically ventilated.

You may qualify if:

• Mechanically ventilated neonates and infants (\<1 year of age).
• Inpatients in the cardiac or neonatal intensive care unit at Boston Children's Hospital.
• Assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes.
• Written parental informed consent.

You may not qualify if:

• Hemodynamic or respiratory instability.
• Patients on extracorporeal membrane oxygenation support.
• Clinically significant tracheo-esophageal fistula
• Measured endotracheal tube leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Innovision: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Nachman E, Clemensen P, Santos K, Cole AR, Polizzotti BD, Hofmann G, Leeman KT, van den Bosch SJ, Kheir JN. A Device for the Quantification of Oxygen Consumption and Caloric Expenditure in the Neonatal Range. Anesth Analg. 2018 Jul;127(1):95-104. doi: 10.1213/ANE.0000000000003308.

  PMID: 29505450 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: July 5, 2017
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)