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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

Tracking Information
First Submitted Date January 10, 2019
First Posted Date January 14, 2019
Last Update Posted Date May 12, 2020
Estimated Study Start Date March 1, 2022
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2019)
Average caloric expenditure [ Time Frame: through study completion, an average of 3 days ]
Number of calories consumed
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
Official Title Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Mechanically ventilated children.
Condition
  • Calorie Overload
  • Calorie Deficiency
Intervention Device: Monitoring of energy expenditure
Continuous monitoring of energy expenditure.
Study Groups/Cohorts
  • Neonates
    Neonates 0-28 days
    Intervention: Device: Monitoring of energy expenditure
  • Infant
    29 days to 1 year
    Intervention: Device: Monitoring of energy expenditure
  • Child
    >1 year and <10 kg
    Intervention: Device: Monitoring of energy expenditure
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 11, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03803657
Other Study ID Numbers IRB-P00030228
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party John Kheir, Boston Children's Hospital
Study Sponsor Boston Children's Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Boston Children's Hospital
Verification Date May 2020