TerminatedNot Applicable

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.

Stopped: Recuitment to slow

Belgium41 participantsStarted 2017-05-03

Plain-language 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.

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

positive nitrogen balance

Timeframe: Day 5 post operative

Trial details

NCT IDNCT03136900

SponsorQueen Fabiola Children's University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-17