Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants.
NCT ID: NCT03136900
Last Updated: 2020-06-22
Study Results
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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TERMINATED
NA
41 participants
INTERVENTIONAL
2017-05-03
2020-04-17
Brief Summary
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After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The caloric intake is not the only important nutritional variable in PICU. The protein intake objective is around 1,5g/kg/d in order to reduce muscular catabolism.
The aim of this study is to compare the impact of an isocaloric enteral diet, either fortified by milk concentration (in order to increase the protein intake) or by a supplement of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart disease.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Study Diet
Enteral diet made of Nutrilon without lactose® fortified by concentration
Nutrilon without lactose® fortified by concentration
enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%
Control Diet
Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation.
Nutrilon without lactose® fortified by Maltodextrin and oil supplementation
enteral diet with cow milk protein-based infant formula without lactose 14%
Interventions
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Nutrilon without lactose® fortified by concentration
enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%
Nutrilon without lactose® fortified by Maltodextrin and oil supplementation
enteral diet with cow milk protein-based infant formula without lactose 14%
Eligibility Criteria
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Inclusion Criteria
* Expected stay of 5 days in PICU after surgery
* Expected need of invasive ventilation for 48h after surgery
* Expected need for enteral feeding during 5 days.
* Obtaining the informed consent of the child's legal guardian after being informed of the goals, benefits and potential risks of this study
Exclusion Criteria
* ECMO
* Dialysis
2 Years
ALL
No
Sponsors
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Queen Fabiola Children's University Hospital
OTHER
Responsible Party
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Locations
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Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, , Belgium
Countries
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Other Identifiers
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P2017/PICU/DIETCHIRCARD
Identifier Type: -
Identifier Source: org_study_id
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