Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

March 8, 2023 updated by: John Kheir, Boston Children's Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Mechanically ventilated children.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average caloric expenditure
Time Frame: through study completion, an average of 3 days
Number of calories consumed
through study completion, an average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-P00030228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Calorie Deficiency

Clinical Trials on Monitoring of energy expenditure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe