DIETCHIRCARD: 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.

Sponsor

Queen Fabiola Children's University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03136900

Collaborator

(none)

Enrollment

Location

Arms

35.5

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease in Children	Dietary Supplement: Nutrilon without lactose® fortified by concentration Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

May 3, 2017

Actual Primary Completion Date :

Apr 17, 2020

Actual Study Completion Date :

Apr 17, 2020

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

positive nitrogen balance [Day 5 post operative]

Secondary Outcome Measures

duration of enteral feeding [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
length of hospital stay in hospital [up to 120 days post operative]
duration in hour

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels		Belgium	1020

Sponsors and Collaborators

Queen Fabiola Children's University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Queen Fabiola Children's University Hospital

ClinicalTrials.gov Identifier:

NCT03136900

Other Study ID Numbers:

P2017/PICU/DIETCHIRCARD

First Posted:

May 2, 2017

Last Update Posted:

Jun 22, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Study Results

No Results Posted as of Jun 22, 2020