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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. (DIETCHIRCARD)

Primary Purpose

Congenital Heart Disease in Children

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nutrilon without lactose® fortified by concentration
Nutrilon without lactose® fortified by Maltodextrin and oil supplementation
Sponsored by
Queen Fabiola Children's University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease in Children

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Universitaire Des Enfants Reine Fabiola

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Diet

Control Diet

Arm Description

Enteral diet made of Nutrilon without lactose® fortified by concentration

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

Outcomes

Primary Outcome Measures

positive nitrogen balance

Secondary Outcome Measures

duration of enteral feeding
duration in hour
duration of invasive or non-invasive ventilatory support
duration in hour
length of hospital stay in intensive care unit
duration in hour
length of hospital stay in hospital
duration in hour

Full Information

First Posted
April 28, 2017
Last Updated
June 19, 2020
Sponsor
Queen Fabiola Children's University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03136900
Brief Title
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.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Recuitment to slow
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
April 17, 2020 (Actual)
Study Completion Date
April 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Fabiola Children's University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease in Children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Diet
Arm Type
Experimental
Arm Description
Enteral diet made of Nutrilon without lactose® fortified by concentration
Arm Title
Control Diet
Arm Type
Active Comparator
Arm Description
Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrilon without lactose® fortified by concentration
Intervention Description
enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrilon without lactose® fortified by Maltodextrin and oil supplementation
Intervention Description
enteral diet with cow milk protein-based infant formula without lactose 14%
Primary Outcome Measure Information:
Title
positive nitrogen balance
Time Frame
Day 5 post operative
Secondary Outcome Measure Information:
Title
duration of enteral feeding
Description
duration in hour
Time Frame
up to 120 days post operative
Title
duration of invasive or non-invasive ventilatory support
Description
duration in hour
Time Frame
up to 120 days post operative
Title
length of hospital stay in intensive care unit
Description
duration in hour
Time Frame
up to 120 days post operative
Title
length of hospital stay in hospital
Description
duration in hour
Time Frame
up to 120 days post operative

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital Universitaire Des Enfants Reine Fabiola
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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