Preoperative Nutritional Intervention and Outcomes of Children Submitted to Heart Surgery for Congenital Heart Diseases

Study Overview
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Brief Summary
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The hypothesis of this study is a nutrition preoperatively in infants and children undergoing elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional status, intervention, and that this results in good postoperative results.

Detailed Description
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If this hypothesis is confirmed, there will be subsidies for systematic implementation of nutritional interventions in patients seen in service.

Official Title
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Preoperative Nutritional Intervention and Outcomes Postoperative of Children Submitted to Heart Surgery for Congenital Heart Diseases

Conditions
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Congenital Heart Disease, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Nutritional intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with congenital heart disease requiring elective surgical correction; Age> 30 days and ≤ 5 years, with the aim of excluding the neonatal period, which are operated children with complex heart defects, and older children, where the time living with the disease damages the myocardium and the pulmonary circulation, leaving only children with fewer serious and, in general, are less subjected to complex surgery diseases. Exclusion Criteria: Chronic gastrointestinal diseases (defects, malabsorption, celiac disease, inflammatory bowel disease, diabetes mellitus); Patients with other organic defects that may compromise the growth and / or nutritional status; Patients undergoing emergency surgery; Request of parents or guardians at any time; Patients receiving exclusive breastfeeding; Died during the study period; Patients using cardiac pacemaker or other electrical or electronic device that interferes with the reading of the electrical bioimpedance.

Ages Eligible for Study
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Minimum Age: 30 Days
Maximum Age: 5 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional intervention<br>Consultation with a dietitian, including nutritional recommendations and supplementation. | Dietary Supplement: Nutritional intervention<br>* Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.<br>|
| No Intervention: Standard therapy<br>No specific nutritional recommendations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Weight-for-age z-score | 30 to 45 days prior to surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcomes | Length-of-hospital-stay | on average 15 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Congenital heart disease, Nutritional status, Bioelectrical impedance