NCT02647541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

December 10, 2015

Last Update Submit

January 5, 2016

Conditions

Congenital Heart DiseaseMalnutrition

Keywords

ChildrenCongenital heart diseaseNutritional statusBioelectrical impedance

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Weight-for-age z-score

    30 to 45 days prior to surgery

Secondary Outcomes (1)

  • Surgical outcomes

    on average 15 days after surgery

Study Arms (2)

Nutritional intervention

EXPERIMENTAL

Consultation with a dietitian, including nutritional recommendations and supplementation.

Dietary Supplement: Nutritional intervention

Standard therapy

NO INTERVENTION

No specific nutritional recommendations.

Interventions

Nutritional interventionDIETARY_SUPPLEMENT

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

Nutritional intervention

Eligibility Criteria

Age30 Days - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine of Ribeirão Preto / USP

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Heart Defects, CongenitalMalnutrition

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Thatiane D Santos, Msc

    FMRP/USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RD, MSc

Study Record Dates

First Submitted

December 10, 2015

First Posted

January 6, 2016

Study Start

February 1, 2011

Primary Completion

February 1, 2013

Study Completion

November 1, 2013

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

BR(1)