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

U

University of Sao Paulo

Status

Completed

Conditions

Malnutrition
Congenital Heart Disease

Treatments

Dietary Supplement: Nutritional intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02647541
TSantos

Details and patient eligibility

About

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.

Full description

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

Enrollment

11 patients

Sex

All

Ages

30 days to 5 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 2 patient groups

Nutritional intervention
Experimental group
Description:
Consultation with a dietitian, including nutritional recommendations and supplementation.
Treatment:
Dietary Supplement: Nutritional intervention
Standard therapy
No Intervention group
Description:
No specific nutritional recommendations.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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