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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647541
• Other study ID #: TSantos
• Status: Completed
• Phase: N/A
• First received: December 10, 2015
• Last updated: January 5, 2016
• Start date: February 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Malnutrition

Intervention

Dietary Supplement:
• Nutritional intervention
Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.

Locations

Country	Name	City	State
Brazil	Faculty of Medicine of Ribeirão Preto / USP	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	Weight-for-age z-score	30 to 45 days prior to surgery	No
Secondary	Surgical outcomes	Length-of-hospital-stay	on average 15 days after surgery	No