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.

Study Overview
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Brief Summary
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An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality. 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.

Official Title
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Controlled, Randomized, Double-blind, Monocentric Clinical Study Evaluating the Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation, After Surgery for Congenital Heart Disease, in Children Aged Zero to Two Years Old

Conditions
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Congenital Heart Disease in Children

Intervention / Treatment
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* Dietary Supplement: Nutrilon without lactose® fortified by concentration
* Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from 0 to 2 years undergoing cardiac surgery (corrective or palliative) for congenital heart surgery, with or without extracorporeal circulation 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: Medical indications for specific diet ECMO Dialysis

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Diet<br>Enteral diet made of Nutrilon without lactose® fortified by concentration | Dietary Supplement: Nutrilon without lactose® fortified by concentration<br>* enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%<br>|
| Active Comparator: Control Diet<br>Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation. | Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation<br>* enteral diet with cow milk protein-based infant formula without lactose 14%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive nitrogen balance |  | Day 5 post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of enteral feeding | duration in hour | up to 120 days post operative | 
| duration of invasive or non-invasive ventilatory support | duration in hour | up to 120 days post operative | 
| length of hospital stay in intensive care unit | duration in hour | up to 120 days post operative | 
| length of hospital stay in hospital | duration in hour | up to 120 days post operative |