Back to resultsPreoperative Nutritional Intervention and Outcomes of Children Submitted to Heart Surgery for Congenital Heart Diseases
Primary Purpose
Congenital Heart Disease, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nutritional intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Congenital Heart Disease focused on measuring Children, Congenital heart disease, Nutritional status, Bioelectrical impedance
Eligibility 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.
Sites / Locations
- Faculty of Medicine of Ribeirão Preto / USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional intervention
Standard therapy
Arm Description
Consultation with a dietitian, including nutritional recommendations and supplementation.
No specific nutritional recommendations.
Outcomes
Primary Outcome Measures
Nutritional status
Weight-for-age z-score
Secondary Outcome Measures
Surgical outcomes
Length-of-hospital-stay
Full Information
NCT ID
NCT02647541
First Posted
December 10, 2015
Last Updated
January 5, 2016
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02647541
Brief Title
Preoperative Nutritional Intervention and Outcomes of Children Submitted to Heart Surgery for Congenital Heart Diseases
Official Title
Preoperative Nutritional Intervention and Outcomes Postoperative of Children Submitted to Heart Surgery for Congenital Heart Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Malnutrition
Keywords
Children, Congenital heart disease, Nutritional status, Bioelectrical impedance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional intervention
Arm Type
Experimental
Arm Description
Consultation with a dietitian, including nutritional recommendations and supplementation.
Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
No specific nutritional recommendations.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional intervention
Intervention Description
Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.
Primary Outcome Measure Information:
Title
Nutritional status
Description
Weight-for-age z-score
Time Frame
30 to 45 days prior to surgery
Secondary Outcome Measure Information:
Title
Surgical outcomes
Description
Length-of-hospital-stay
Time Frame
on average 15 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thatiane D Santos, Msc
Organizational Affiliation
FMRP/USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine of Ribeirão Preto / USP
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
12. IPD Sharing Statement
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Preoperative Nutritional Intervention and Outcomes of Children Submitted to Heart Surgery for Congenital Heart Diseases
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