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.

Congenital Heart Disease in Children Clinical Trial

— DIETCHIRCARD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03136900
• Other study ID #: P2017/PICU/DIETCHIRCARD
• Status: Terminated
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: April 17, 2020

Study information

• Verified date: June 2020
• Source: Queen Fabiola Children's University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: April 17, 2020
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases

Intervention

Dietary Supplement:
• Nutrilon without lactose® fortified by concentration
enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%
• Nutrilon without lactose® fortified by Maltodextrin and oil supplementation
enteral diet with cow milk protein-based infant formula without lactose 14%

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive nitrogen balance		Day 5 post operative
Secondary	duration of enteral feeding	duration in hour	up to 120 days post operative
Secondary	duration of invasive or non-invasive ventilatory support	duration in hour	up to 120 days post operative
Secondary	length of hospital stay in intensive care unit	duration in hour	up to 120 days post operative
Secondary	length of hospital stay in hospital	duration in hour	up to 120 days post operative