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
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease Malnutrition||Dietary Supplement: Nutritional intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|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|
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.
- Nutritional status [ Time Frame: 30 to 45 days prior to surgery ]Weight-for-age z-score
- Surgical outcomes [ Time Frame: on average 15 days after surgery ]Length-of-hospital-stay
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
|Faculty of Medicine of Ribeirão Preto / USP|
|Ribeirão Preto, São Paulo, Brazil, 14049-900|
|Principal Investigator:||Thatiane D Santos, Msc||FMRP/USP|