Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants. (DIETCHIRCARD)

Controlled, Randomized, Double-blind, Monocentric Clinical Study Evaluating the Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation, After Surgery for Congenital Heart Disease, in Children Aged Zero to Two Years Old

An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.

After a cardiac surgery, the energy expenditure is estimated to be around 55 kcal/kg/d. The caloric intake is not the only important nutritional variable in PICU. The protein intake objective is around 1,5g/kg/d in order to reduce muscular catabolism.

The aim of this study is to compare the impact of an isocaloric enteral diet, either fortified by milk concentration (in order to increase the protein intake) or by a supplement of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart disease.

Study Overview

• Status: Terminated
• Conditions: Congenital Heart Disease in Children
• Intervention / Treatment: Dietary supplement: Nutrilon without lactose® fortified by concentration; Dietary supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children from 0 to 2 years undergoing cardiac surgery (corrective or palliative) for congenital heart surgery, with or without extracorporeal circulation
• Expected stay of 5 days in PICU after surgery
• Expected need of invasive ventilation for 48h after surgery
• Expected need for enteral feeding during 5 days.
• Obtaining the informed consent of the child's legal guardian after being informed of the goals, benefits and potential risks of this study

Exclusion Criteria:

• Medical indications for specific diet
• ECMO
• Dialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study Diet; Enteral diet made of Nutrilon without lactose® fortified by concentration	Dietary supplement: Nutrilon without lactose® fortified by concentration; enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%
ACTIVE_COMPARATOR: Control Diet; Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation.	Dietary supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation; enteral diet with cow milk protein-based infant formula without lactose 14%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
positive nitrogen balance	Day 5 post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of enteral feeding	duration in hour	up to 120 days post operative
duration of invasive or non-invasive ventilatory support	duration in hour	up to 120 days post operative
length of hospital stay in intensive care unit	duration in hour	up to 120 days post operative
length of hospital stay in hospital	duration in hour	up to 120 days post operative

Collaborators and Investigators

• Sponsor: Queen Fabiola Children's University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2017
• Primary Completion (ACTUAL): April 17, 2020
• Study Completion (ACTUAL): April 17, 2020

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (ACTUAL): May 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: P2017/PICU/DIETCHIRCARD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No