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

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ClinicalTrials.gov Identifier: NCT02647541
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Thatiane Danielly Santos, 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Malnutrition Dietary Supplement: Nutritional intervention Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Preoperative Nutritional Intervention and Outcomes Postoperative of Children Submitted to Heart Surgery for Congenital Heart Diseases
Study Start Date : February 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutritional intervention
Consultation with a dietitian, including nutritional recommendations and supplementation.
Dietary Supplement: Nutritional intervention
Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.

No Intervention: Standard therapy
No specific nutritional recommendations.



Primary Outcome Measures :
  1. Nutritional status [ Time Frame: 30 to 45 days prior to surgery ]
    Weight-for-age z-score


Secondary Outcome Measures :
  1. Surgical outcomes [ Time Frame: on average 15 days after surgery ]
    Length-of-hospital-stay



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647541


Locations
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Brazil
Faculty of Medicine of Ribeirão Preto / USP
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Thatiane D Santos, Msc FMRP/USP

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Responsible Party: Thatiane Danielly Santos, RD, MSc, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02647541     History of Changes
Other Study ID Numbers: TSantos
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016

Keywords provided by Thatiane Danielly Santos, University of Sao Paulo:
Children
Congenital heart disease
Nutritional status
Bioelectrical impedance

Additional relevant MeSH terms:
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Heart Diseases
Malnutrition
Heart Defects, Congenital
Cardiovascular Diseases
Nutrition Disorders
Cardiovascular Abnormalities
Congenital Abnormalities