Congenital Heart DiseaseNCT02647541
Preoperative Nutritional Intervention and Outcomes of Children Submitted to Heart Surgery for Congenital Heart Diseases
A study testing Nutritional intervention in people with Congenital Heart Disease and Malnutrition, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The hypothesis of this study is a nutrition preoperatively in infants and children undergoing elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional status, intervention, and that this results in good postoperative results. Read more about this study
- Who is it for?
- Ages 30 days to 5 years
- Conditions the study is for
- Congenital Heart Disease, Malnutrition
- What is being tested?
- Nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Nov 2013
- 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 30 days to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with congenital heart disease requiring elective surgical correction;
- Age> 30 days and ≤ 5 years, with the aim of excluding the neonatal period, which are operated children with complex heart defects, and older children, where the time living with the disease damages the myocardium and the pulmonary circulation, leaving only children with fewer serious and, in general, are less subjected to complex surgery diseases.
Who cannot join
- Chronic gastrointestinal diseases (defects, malabsorption, celiac disease, inflammatory bowel disease, diabetes mellitus);
- Patients with other organic defects that may compromise the growth and / or nutritional status;
- Patients undergoing emergency surgery;
- Request of parents or guardians at any time;
- Patients receiving exclusive breastfeeding;
- Died during the study period;
- Patients using cardiac pacemaker or other electrical or electronic device that interferes with the reading of the electrical bioimpedance.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Medicine of Ribeirão Preto / USP
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Preoperative Nutritional Intervention and Outcomes Postoperative of Children Submitted to Heart Surgery for Congenital Heart Diseases
The hypothesis of this study is a nutrition preoperatively in infants and children undergoing elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional status, intervention, and that this results in good postoperative results.
Read the detailed description
If this hypothesis is confirmed, there will be subsidies for systematic implementation of nutritional interventions in patients seen in service.
- Conditions
- Congenital Heart Disease, Malnutrition
- Being tested
- Nutritional intervention
- Keywords
- Children, Congenital heart disease, Nutritional status, Bioelectrical impedance
- Medical subject headings
- Heart Defects, Congenital, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionDietary supplement
Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention | Experimental | Consultation with a dietitian, including nutritional recommendations and supplementation. Receives: Dietary Supplement: Nutritional intervention |
| Standard therapy | No intervention | No specific nutritional recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Weight-for-age z-score
Measured: 30 to 45 days prior to surgery
Secondary outcomes (1)
Surgical outcomes
Length-of-hospital-stay
Measured: on average 15 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thatiane Danielly Santos, University of Sao Paulo
- Investigators
- Thatiane D Santos, Msc, Principal investigator, FMRP/USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647541
- Sponsor's protocol ID
- TSantos
- Status last verified
- Jan 2016
- First submitted
- 10 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Nutritional Intervention and Outcomes Postoperative of Children Submitted to Heart Surgery for Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT02647541
- Acronym / sponsor ID
- TSantos
- Conditions
- Congenital Heart Disease, Malnutrition
- Keywords
- Children, Congenital heart disease, Nutritional status, Bioelectrical impedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Jan 2016 (estimated)
- 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.
The hypothesis of this study is a nutrition preoperatively in infants and children undergoing elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional status, intervention, and that this results in good postoperative results.
Detailed description
If this hypothesis is confirmed, there will be subsidies for systematic implementation of nutritional interventions in patients seen in service.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention | Experimental | Dietary Supplement: Nutritional interventionConsultation with a dietitian, including nutritional recommendations and supplementation. |
| Standard therapy | No intervention | –No specific nutritional recommendations. |
Who may qualify
- Ages
- 30 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient with congenital heart disease requiring elective surgical correction;
- Age> 30 days and ≤ 5 years, with the aim of excluding the neonatal period, which are operated children with complex heart defects, and older children, where the time living with the disease damages the myocardium and the pulmonary circulation, leaving only children with fewer serious and, in general, are less subjected to complex surgery diseases.
Key exclusion criteria (7 listed)
- Chronic gastrointestinal diseases (defects, malabsorption, celiac disease, inflammatory bowel disease, diabetes mellitus);
- Patients with other organic defects that may compromise the growth and / or nutritional status;
- Patients undergoing emergency surgery;
- Request of parents or guardians at any time;
- Patients receiving exclusive breastfeeding;
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 |
|---|---|---|
| Nutritional interventionConsultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas. | Dietary supplement | Nutritional intervention |
Primary outcome
Nutritional status
Time frame: 30 to 45 days prior to surgery
Weight-for-age z-score
1 secondary outcome
Surgical outcomes
Time frame: on average 15 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
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.
Thatiane D Santos, Msc principal investigator
FMRP/USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention in people with Congenital Heart Disease and Malnutrition, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 6 Jan 2016. 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 Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nutritional status (time frame: 30 to 45 days prior to surgery). 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 6 Jan 2016.