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.

NCT03136900 | Terminated

• 1 other identifier: P2017/PICU/DIETCHIRCARD
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease in Children

Outcome Measures

Primary Outcomes (1)

• positive nitrogen balance

  Day 5 post operative

Secondary Outcomes (4)

• duration of enteral feeding

  up to 120 days post operative

• duration of invasive or non-invasive ventilatory support

  up to 120 days post operative

• length of hospital stay in intensive care unit

  up to 120 days post operative

• length of hospital stay in hospital

  up to 120 days post operative

Study Arms (2)

Study Diet

EXPERIMENTAL

Enteral diet made of Nutrilon without lactose® fortified by concentration

Dietary Supplement: Nutrilon without lactose® fortified by concentration

Control Diet

ACTIVE COMPARATOR

Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation.

Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation

Interventions

Nutrilon without lactose® fortified by concentration DIETARY_SUPPLEMENT

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

Study Diet

Nutrilon without lactose® fortified by Maltodextrin and oil supplementation DIETARY_SUPPLEMENT

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

Control Diet

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Medical indications for specific diet
• ECMO
• Dialysis

Sponsors & Collaborators

• Queen Fabiola Children's University Hospital: lead

Study Sites (1)

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: May 3, 2017
• Primary Completion: April 17, 2020
• Study Completion: April 17, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)