Trials / Terminated
TerminatedNCT03136900
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.
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Queen Fabiola Children's University Hospital · Academic / Other
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Nutrilon without lactose® fortified by concentration | enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14% |
| DIETARY_SUPPLEMENT | Nutrilon without lactose® fortified by Maltodextrin and oil supplementation | enteral diet with cow milk protein-based infant formula without lactose 14% |
Timeline
- Start date
- 2017-05-03
- Primary completion
- 2020-04-17
- Completion
- 2020-04-17
- First posted
- 2017-05-02
- Last updated
- 2020-06-22
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03136900. Inclusion in this directory is not an endorsement.