Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

NCT ID: NCT03803657

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-03-01

Brief Summary

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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

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Conditions

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Calorie Overload Calorie Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonates

Neonates 0-28 days

Monitoring of energy expenditure

Intervention Type DEVICE

Continuous monitoring of energy expenditure.

Infant

29 days to 1 year

Monitoring of energy expenditure

Intervention Type DEVICE

Continuous monitoring of energy expenditure.

Child

\>1 year and \<10 kg

Monitoring of energy expenditure

Intervention Type DEVICE

Continuous monitoring of energy expenditure.

Interventions

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Monitoring of energy expenditure

Continuous monitoring of energy expenditure.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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John Kheir

Staff physician

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 29505450 (View on PubMed)

Other Identifiers

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IRB-P00030228

Identifier Type: -

Identifier Source: org_study_id

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