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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02647541

Enrollment

Registered

2016-01-06

Start date

2011-02-28

Completion date

2013-11-30

Last updated

2016-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Malnutrition

Keywords

Children, Congenital heart disease, Nutritional status, Bioelectrical impedance

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.

Interventions

DIETARY_SUPPLEMENTNutritional intervention

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Days to 5 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026