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.

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03136900

Acronym

DIETCHIRCARD

Enrollment

Registered

2017-05-02

Start date

2017-05-03

Completion date

2020-04-17

Last updated

2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease in Children

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTNutrilon without lactose® fortified by concentration

enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%

DIETARY_SUPPLEMENTNutrilon without lactose® fortified by Maltodextrin and oil supplementation

enteral diet with cow milk protein-based infant formula without lactose 14%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
positive nitrogen balance	Day 5 post operative

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026