NCT03803657

Brief Summary

The investigators have created and validated a device that allows us to accurately measure how many calories a baby consumes every day. The purpose of this study is to compare how many calories a baby consumes with how many calories are provided in a population of newborn infants and children. This may help clinicians to better understand how to feed babies during times of critical illness.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
4.1 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

January 10, 2019

Last Update Submit

March 8, 2023

Conditions

Calorie OverloadCalorie Deficiency

Outcome Measures

Primary Outcomes (1)

  • Average caloric expenditure

    Number of calories consumed

    through study completion, an average of 3 days

Study Arms (3)

Neonates

Neonates 0-28 days

Device: Monitoring of energy expenditure

Infant

29 days to 1 year

Device: Monitoring of energy expenditure

Child

\>1 year and \<10 kg

Device: Monitoring of energy expenditure

Interventions

Monitoring of energy expenditureDEVICE

Continuous monitoring of energy expenditure.

ChildInfantNeonates

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mechanically ventilated children.

You may qualify if:

  • Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg
  • Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit
  • Assent of patient's intensive care attending physician
  • Written parental informed consent.
  • Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen \<80%.

You may not qualify if:

  • Clinically significant tracheo-esophageal fistula
  • Measured ETT leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)
  • Patient on high frequency oscillatory ventilation or high frequency jet ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 29505450BACKGROUND
0

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

January 10, 2019

First Posted

January 14, 2019

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 9, 2023

Record last verified: 2023-03