Calorie OverloadNCT03803657
Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
An observational study of Calorie Overload and Calorie Deficiency, run by Boston Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Calorie Overload, Calorie Deficiency
- What is being tested?
- Monitoring of energy expenditure
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mechanically ventilated children.
Who may be able to join
- 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%.
Who cannot join
- 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.
About this study
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.
- Conditions
- Calorie Overload, Calorie Deficiency
- Being tested
- Monitoring of energy expenditure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of energy expenditureDevice
Continuous monitoring of energy expenditure.
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Neonates 0-28 days Receives: Device: Monitoring of energy expenditure | |
| Infant | 29 days to 1 year Receives: Device: Monitoring of energy expenditure | |
| Child | >1 year and <10 kg Receives: Device: Monitoring of energy expenditure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average caloric expenditure
Number of calories consumed
Measured: through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Mar 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Why it stopped: Never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calorie OverloadStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kheir, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803657
- Sponsor's protocol ID
- IRB-P00030228
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2019
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 29505450
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
- ClinicalTrials.gov ID
- NCT03803657
- Acronym / sponsor ID
- IRB-P00030228
- Conditions
- Calorie Overload, Calorie Deficiency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | Device: Monitoring of energy expenditureNeonates 0-28 days |
| Infant | – | Device: Monitoring of energy expenditure29 days to 1 year |
| Child | – | Device: Monitoring of energy expenditure>1 year and <10 kg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mechanically ventilated children.
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of energy expenditureContinuous monitoring of energy expenditure. | Device | Child, Infant, Neonates |
Primary outcome
Average caloric expenditure
Time frame: through study completion, an average of 3 days
Number of calories consumed
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 29505450Nachman 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Calorie Overload and Calorie Deficiency, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average caloric expenditure (time frame: through study completion, an average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.