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Individualized Metabolic Assessment and Nutritional Optimization in Children With Chronic Respiratory Insufficiency

Individualized Metabolic Assessment and Nutritional Optimization in Children With Chronic Respiratory Insufficiency on Ventilatory Support at Home

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02354495
Acronym
NutriCAPE
Enrollment
16
Registered
2015-02-03
Start date
2013-08-31
Completion date
2015-06-30
Last updated
2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition

Keywords

Indirect calorimetry, Protein, Mechanical ventilation, Respiratory failure

Brief summary

The investigators aim to examine the feasibility of individualized diet intervention in children dependent on long-term mechanical ventilator support at home. The investigators will use a multidisciplinary model that will allow for diet modification based on comprehensive nutrition, metabolic and respiratory assessments performed in the subjects' home. the impact of this intervention (for 12 weeks) on body composition and respiratory variables will be assessed.

Detailed description

A strategy of individualized diet intervention and its impact on respiratory and nutritional outcomes in children on long-term mechanical ventilation has not been previously evaluated. The investigators' objective is to assess the feasibility of individualized diet intervention in children dependent on long-term mechanical ventilator support using a multidisciplinary model. The investigators will optimize energy intake (based on indirect calorimetric measurement) and protein intake (based on recommended intake values) in this group. The subjects will be administered the modified diet for 12 weeks, and a comprehensive nutrition, metabolic and respiratory assessment will be performed before and after intervention, in the subjects' home. The investigators will examine the effect of individualized diet optimization on nutritional status, body composition, CO2 production (VCO2) and minute ventilation (MV). The investigators hypothesize that optimizing energy and protein intake would be associated with improved nutritional status, particularly increment in LBM, and decrease in VCO2 and MV. If nutritional optimization is associated with positive outcomes in our study cohort, this concept could be generalized to a wider patient population with respiratory insufficiency.

Interventions

DIETARY_SUPPLEMENTChanges in energy and protein intake

Energy intake will be based on accurate measurements of energy expenditure. Protein intake will be matched to age-based recommended values if necessary.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

\- Children aged 1 month to 17 years will be included if they were dependent on at least 12 hours of mechanical ventilation per day via a cuffed tracheostomy tube, with a fractional oxygen requirement (FiO2) less than 0.6, and a leak less than 10% around the cuff at the time of data collection

Exclusion criteria

-Intercurrent illness such as fever, seizures and/or infectious disease in the 24 hours preceding the study, and/or respiratory decompensation requiring an increase in ventilator settings of \>20% from baseline in the 72 hours preceding the study

Design outcomes

Primary

MeasureTime frameDescription
Lean body mass12 weekschange in LBM after 12 weeks of modified diet
Carbon dioxide production (VCO2)12 weeksChange in VCO2 (ml/min) after 12 weeks on modified diet
Minute ventilation (L/min)12 weeksChange in minute ventilation (L/min) after 12 weeks on modified diet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026