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Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

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ClinicalTrials.gov Identifier: NCT03803657
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
John Kheir, Boston Children's Hospital

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.

Condition or disease Intervention/treatment
Calorie Overload Calorie Deficiency Device: Monitoring of energy expenditure

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Group/Cohort Intervention/treatment
Neonates
Neonates 0-28 days
Device: Monitoring of energy expenditure
Continuous monitoring of energy expenditure.

Infant
29 days to 1 year
Device: Monitoring of energy expenditure
Continuous monitoring of energy expenditure.

Child
>1 year and <10 kg
Device: Monitoring of energy expenditure
Continuous monitoring of energy expenditure.




Primary Outcome Measures :
  1. Average caloric expenditure [ Time Frame: through study completion, an average of 3 days ]
    Number of calories consumed



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically ventilated children.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Clinically significant tracheo-esophageal fistula
  2. Measured ETT leak >20% (i.e. difference between inspiratory and expiratory tidal volumes)
  3. Patient on high frequency oscillatory ventilation or high frequency jet ventilation.
Publications:
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Responsible Party: John Kheir, Staff physician, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03803657    
Other Study ID Numbers: IRB-P00030228
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No