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Clinical Trials/NCT02354495
NCT02354495
Completed
N/A

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

Boston Children's Hospital0 sites16 target enrollmentAugust 2013
ConditionsNutrition

Overview

Phase
N/A
Intervention
Not specified
Conditions
Nutrition
Sponsor
Boston Children's Hospital
Enrollment
16
Primary Endpoint
Carbon dioxide production (VCO2)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nilesh M. Mehta

Associate Professor in Anesthesia, Critical Care

Boston Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Carbon dioxide production (VCO2)

Time Frame: 12 weeks

Change in VCO2 (ml/min) after 12 weeks on modified diet

Lean body mass

Time Frame: 12 weeks

change in LBM after 12 weeks of modified diet

Minute ventilation (L/min)

Time Frame: 12 weeks

Change in minute ventilation (L/min) after 12 weeks on modified diet

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