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.

Not Applicable

Terminated

• Conditions: Congenital Heart Disease in Children
• Interventions: Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation; Dietary Supplement: Nutrilon without lactose® fortified by concentration

• Registration Number: NCT03136900
• Lead Sponsor: Queen Fabiola Children's University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-02
• Study Start: 2017-05-03
• Primary Completion: 2020-04-17
• Study Completion: 2020-04-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-19
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Diet	Nutrilon without lactose® fortified by Maltodextrin and oil supplementation	Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation.
Study Diet	Nutrilon without lactose® fortified by concentration	Enteral diet made of Nutrilon without lactose® fortified by concentration

Primary Outcome Measures

Name	Time	Method
positive nitrogen balance	Day 5 post operative

Secondary Outcome Measures

Name	Time	Method
duration of enteral feeding	up to 120 days post operative	duration in hour
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

Trial Locations

Locations (1)

Hôpital Universitaire Des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium