Congenital Heart Disease in ChildrenDIETCHIRCARDNCT03136900
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.
A study testing Nutrilon without lactose® fortified by concentration and Nutrilon without lactose® fortified by Maltodextrin and oil supplementation in people with Congenital Heart Disease in Children, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Congenital Heart Disease in Children
- What is being tested?
- Nutrilon without lactose® fortified by concentration and Nutrilon without lactose® fortified by Maltodextrin and oil supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- 3 May 2017to 17 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Medical indications for specific diet
- ECMO
- Dialysis
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Congenital Heart Disease in Children
- Being tested
- Nutrilon without lactose® fortified by concentration, Nutrilon without lactose® fortified by Maltodextrin and oil supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrilon without lactose® fortified by concentrationDietary supplement
enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%
Nutrilon without lactose® fortified by Maltodextrin and oil supplementationDietary supplement
enteral diet with cow milk protein-based infant formula without lactose 14%
| Study group | Role | What they receive |
|---|---|---|
| Study Diet | Experimental | Enteral diet made of Nutrilon without lactose® fortified by concentration Receives: Dietary Supplement: Nutrilon without lactose® fortified by concentration |
| Control Diet | Active comparator | Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation. Receives: Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive nitrogen balance
Measured: Day 5 post operative
Secondary outcomes (4)
duration of enteral feeding
duration in hour
Measured: up to 120 days post operative
duration of invasive or non-invasive ventilatory support
duration in hour
Measured: up to 120 days post operative
length of hospital stay in intensive care unit
duration in hour
Measured: up to 120 days post operative
length of hospital stay in hospital
duration in hour
Measured: up to 120 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start3 May 2017
- Primary completion17 Apr 2020
- Study completion17 Apr 2020
Why it stopped: Recuitment to slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136900
- Sponsor's protocol ID
- P2017/PICU/DIETCHIRCARD
- Acronym
- DIETCHIRCARD
- Status last verified
- Jun 2020
- First submitted
- 28 Apr 2017
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03136900
- Acronym / sponsor ID
- DIETCHIRCARD / P2017/PICU/DIETCHIRCARD
- Conditions
- Congenital Heart Disease in Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recuitment to slow
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Diet | Experimental | Dietary Supplement: Nutrilon without lactose® fortified by concentrationEnteral diet made of Nutrilon without lactose® fortified by concentration |
| Control Diet | Active comparator | Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementationEnteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Medical indications for specific diet
- ECMO
- Dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrilon without lactose® fortified by concentrationenteral diet with cow milk protein-based infant formula without lactose 20% in place of 14% | Dietary supplement | Study Diet |
| Nutrilon without lactose® fortified by Maltodextrin and oil supplementationenteral diet with cow milk protein-based infant formula without lactose 14% | Dietary supplement | Control Diet |
Primary outcome
positive nitrogen balance
Time frame: Day 5 post operative
4 secondary outcomes
duration of enteral feeding
Time frame: up to 120 days post operative
duration of invasive or non-invasive ventilatory support
Time frame: up to 120 days post operative
length of hospital stay in intensive care unit
Time frame: up to 120 days post operative
length of hospital stay in hospital
Time frame: up to 120 days post operative
Results and safety
The study was stopped early (reason given: Recuitment to slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrilon without lactose® fortified by concentration and Nutrilon without lactose® fortified by Maltodextrin and oil supplementation in people with Congenital Heart Disease in Children, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recuitment to slow). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive nitrogen balance (time frame: Day 5 post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.