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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)

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ClinicalTrials.gov Identifier: NCT03136900
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
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.


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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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%




Primary Outcome Measures :
  1. positive nitrogen balance [ Time Frame: Day 5 post operative ]

Secondary Outcome Measures :
  1. duration of enteral feeding [ Time Frame: up to 120 days post operative ]
    duration in hour

  2. duration of invasive or non-invasive ventilatory support [ Time Frame: up to 120 days post operative ]
    duration in hour

  3. length of hospital stay in intensive care unit [ Time Frame: up to 120 days post operative ]
    duration in hour

  4. length of hospital stay in hospital [ Time Frame: up to 120 days post operative ]
    duration in hour



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136900


Contacts
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Contact: Shancy Rooze, MD 0032 2 477 32 40 shancy.rooze@huderf.be
Contact: Natacha Loumaye, MD natacha.loumaye@ulb.ac.be

Locations
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Belgium
Hôpital Universitaire Des Enfants Reine Fabiola Recruiting
Brussels, Belgium, 1020
Contact: Shancy Rooze, MD    0032 2 477 32 40    shancy.rooze@huderf.be   
Principal Investigator: Shancy Rooze, MD         
Sub-Investigator: Natacha Loumaye, MD         
Sub-Investigator: Corine De Laet, MD         
Sub-Investigator: Dominique Biarent, MD         
Sub-Investigator: Martine Robert, Mrs         
Sub-Investigator: Sid Ali Namane, Mr         
Sponsors and Collaborators
Queen Fabiola Children's University Hospital

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Responsible Party: Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier: NCT03136900     History of Changes
Other Study ID Numbers: P2017/PICU/DIETCHIRCARD
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities