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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-11-30

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.

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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.

Conditions

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Congenital Heart Disease Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nutritional intervention

Consultation with a dietitian, including nutritional recommendations and supplementation.

Group Type EXPERIMENTAL

Nutritional intervention

Intervention Type DIETARY_SUPPLEMENT

Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.

Standard therapy

No specific nutritional recommendations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutritional intervention

Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

30 Days

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No