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

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Malnutrition
• Interventions: Dietary Supplement: Nutritional intervention

• Registration Number: NCT02647541
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2013-02
• Study Completion: 2013-11
• Study First Submitted: 2015-12-10
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-05
• Last Update Submitted: 2016-01-05
• Study First Posted: 2016-01-06
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional intervention	Nutritional intervention	Consultation with a dietitian, including nutritional recommendations and supplementation.

Primary Outcome Measures

Name	Time	Method
Nutritional status	30 to 45 days prior to surgery	Weight-for-age z-score

Secondary Outcome Measures

Name	Time	Method
Surgical outcomes	on average 15 days after surgery	Length-of-hospital-stay

Trial Locations

Locations (1)

Faculty of Medicine of Ribeirão Preto / USP; 🇧🇷 Ribeirão Preto, São Paulo, Brazil