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Completed

NCT Number: NCT02647541

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

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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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

30 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine of Ribeirão Preto / USP

Ribeirão Preto, São Paulo, 14049-900, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional intervention

Dietary Supplement

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

Primary outcomes

  1. Nutritional status

    Time frame: 30 to 45 days prior to surgery

    Weight-for-age z-score

Secondary outcomes

  1. Surgical outcomes

    Time frame: on average 15 days after surgery

    Length-of-hospital-stay

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2016
Registry last updated
Jan 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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