Congenital Heart DiseaseNCT05891210
Nutrition in Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Assiut University.
Trial summary
Congenital heart disease (CHD) defined as anatomic malformation of the heart and great vessels which occurs during intrauterine development irrespective of the age of presentation(1) It is classified into acyanotic and cyanotic depending upon whether the patients clinically exhibit cyanosis(2) . Read more about this study
- Who is it for?
- Ages 5 weeks to 18 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Dec 2024
- Phase
- Observational
- 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 5 weeks to 18 years
- All sexes
- Child, Adult
Study population: Children more than one month and till age of 18 years that present to Assiut University Hospital Units with Cyanotic and ACyanotic Congenital heart disease will be included in our study.
Who may be able to join
- Children more than one month and till age of 18 years that present to Assiut University Hospital Units with Cyanotic and ACyanotic Congenital heart disease will be included in our study.
Who cannot join
- All pediatric patients with comorbidities other than congenital heart disease will be excluded from our study as: severe sepsis, endocarditis, empyema\& autoimmune diseases\& liver cirrhosis\& children receiving immunosuppressive therapy
About this study
Official title: Nutritional Assessment in Children With Congenital Heart Disease
Congenital heart disease (CHD) defined as anatomic malformation of the heart and great vessels which occurs during intrauterine development irrespective of the age of presentation(1) It is classified into acyanotic and cyanotic depending upon whether the patients clinically exhibit cyanosis(2) .
It is the most common human developmental anomaly with a reported prevalence of between 4 to 10 per 1000 live birth (3-6).
Read more
The variety and severity of clinical presentation depend on the cardiac structures involved and their functional impact (7).
Previous studies have found that, although birth weight for gestational age is usually normal in patients with congenital heart disease, young children often present with impaired growth parameters (8,9) The underlying causes of this failure to thrive may be multifactorial including innate growth potential, severity of cardiac underlying disease, increased energy requirements ,decreased nutritional intake, malabsorption and poor utilization of absorbed nutrients .these factor are particularly common and sever in low and middle income countries (11) Several studies suggest that the failure to thrive is associated with poorer cognitive development, learning disabilities, and long term behavioral problems more recently Corbett et al (12) detected a significant association between the severity of growth deficiency and IQ ,whereas Raynor and Rudolf (13) found that 55% of the infants who were failing to thrive exhibited developmental delay .In addition , A study by Reif et al (14) reported that children with a history of failure to thrive were found to have more learning difficulties and evidenced developmental delay at follow up 5 years after the initial presentation(15).
Achieving survival is not the only target of clinicians for these patients, appropriate growth, development and improved quality of life are also very important.
The management of children with congenital heart disease require multidisciplinary approach,in which the nutritional aspect plays an important role ,an adequate caloric intake, in fact this improve the out come of these patients.(7) This study will asses the nutritional status for patients with congenital heart disease Who are admitted at assiut university hospital children and adopting a protocol for nutritional support for them.
Read the detailed description
- Full history taking including date of birth,gender,residence,and socioeconomic status. According To Socioeconomic status we will ask about where the family live,family income (high or middle or low income) Perinatal history as maternal age,gestational diseases,medications use during pregnancy,irradiation exposure ,presence of antenatal care. Natal hisrory ;mode of delivery(vainal,cesarean) ,site of delivery (home,hospital) Post natal history; required resuscitation or not,cyanosis,jaundice and incubator care needed or not,birth weight will be categorized into appropriate ,small or large for gestational age. Feeding history; breast or formula feeding,age of weaning ,type of food for weaning, supplementation of vitamin D.iron.
- All patients will subject to general and systemic examination. Children included in our study will fall under Complete general and systemic examination especially heart disease.
- Nutritional assessment and anthropometric measures will be followed up to these patients; AThe weight ; will be taken on a scale that has been properly calibrated and the value will be plotted on a standardized WHO growth chart .
B)The height ; this measurement for children more than 2years will be taken without shoes using astadiometer and the value will be plotted on the WHO growth chart.
C)The length; this measurement in children 2 years and younger is more accurate ,the child will position in supine on ameasuring board.
D)Head circumference; will be measured using a flexible tabe ,we will measure the maximum diameter through the supraorbital ridge to the occiput and the value will be plotted on the growth chart.
E)Mid arm circumference; this measured using a flexible nonstretch tape laid at the midpoint between the acromion and olecranonprocesses on the shoulder blade and the ulna respectively.
- BMI:
Measured by the person's weight divided by the square of height in meters for children aged more than 2years and will be plotted at the WHO growth chart.
- Conditions
- Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Asses the nutritional status of the children with congenital heart disease
Adopt a protocol to avoid nutritional deficiency and achieve the normal growth in children with congenital heart disease.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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 Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Atia Mohamed Hasanin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891210
- Sponsor's protocol ID
- congenital heart
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05891210
- Acronym / sponsor ID
- congenital heart
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Jun 2023 (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.
Congenital heart disease (CHD) defined as anatomic malformation of the heart and great vessels which occurs during intrauterine development irrespective of the age of presentation(1) It is classified into acyanotic and cyanotic depending upon whether the patients clinically exhibit cyanosis(2) .
It is the most common human developmental anomaly with a reported prevalence of between 4 to 10 per 1000 live birth (3-6).
The variety and severity of clinical presentation depend on the cardiac structures involved and their functional impact (7).
Previous studies have found that, although birth weight for gestational age is usually normal in patients with congenital heart disease, young children often present with impaired growth parameters (8,9) The underlying causes of this failure to thrive may be multifactorial including innate growth potential, severity of cardiac underlying disease, increased energy requirements ,decreased nutritional intake, malabsorption and poor utilization of absorbed nutrients .these factor are particularly common and sever in low and middle income countries (11) Several studies suggest that the failure to thrive is associated with poorer cognitive development, learning disabilities, and long term behavioral problems more recently Corbett et al (12) detected a significant association between the severity of growth deficiency and IQ ,whereas Raynor and Rudolf (13) found that 55% of the infants who were failing to thrive exhibited developmental delay .In addition , A study by Reif et al (14) reported that children with a history of failure to thrive were found to have more learning difficulties and evidenced developmental delay at follow up 5 years after the initial presentation(15).
Achieving survival is not the only target of clinicians for these patients, appropriate growth, development and improved quality of life are also very important.
The management of children with congenital heart disease require multidisciplinary approach,in which the nutritional aspect plays an important role ,an adequate caloric intake, in fact this improve the out come of these patients.(7) This study will asses the nutritional status for patients with congenital heart disease Who are admitted at assiut university hospital children and adopting a protocol for nutritional support for them.
Detailed description
- Full history taking including date of birth,gender,residence,and socioeconomic status. According To Socioeconomic status we will ask about where the family live,family income (high or middle or low income) Perinatal history as maternal age,gestational diseases,medications use during pregnancy,irradiation exposure ,presence of antenatal care. Natal hisrory ;mode of delivery(vainal,cesarean) ,site of delivery (home,hospital) Post natal history; required resuscitation or not,cyanosis,jaundice and incubator care needed or not,birth weight will be categorized into appropriate ,small or large for gestational age. Feeding history; breast or formula feeding,age of weaning ,type of food for weaning, supplementation of vitamin D.iron.
- All patients will subject to general and systemic examination. Children included in our study will fall under Complete general and systemic examination especially heart disease.
- Nutritional assessment and anthropometric measures will be followed up to these patients; AThe weight ; will be taken on a scale that has been properly calibrated and the value will be plotted on a standardized WHO growth chart .
B)The height ; this measurement for children more than 2years will be taken without shoes using astadiometer and the value will be plotted on the WHO growth chart.
C)The length; this measurement in children 2 years and younger is more accurate ,the child will position in supine on ameasuring board.
D)Head circumference; will be measured using a flexible tabe ,we will measure the maximum diameter through the supraorbital ridge to the occiput and the value will be plotted on the growth chart.
E)Mid arm circumference; this measured using a flexible nonstretch tape laid at the midpoint between the acromion and olecranonprocesses on the shoulder blade and the ulna respectively.
- BMI:
Measured by the person's weight divided by the square of height in meters for children aged more than 2years and will be plotted at the WHO growth chart.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 weeks to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children more than one month and till age of 18 years that present to Assiut University Hospital Units with Cyanotic and ACyanotic Congenital heart disease will be included in our study.
Key inclusion criteria (1 listed)
- Children more than one month and till age of 18 years that present to Assiut University Hospital Units with Cyanotic and ACyanotic Congenital heart disease will be included in our study.
Key exclusion criteria (1 listed)
- All pediatric patients with comorbidities other than congenital heart disease will be excluded from our study as: severe sepsis, endocarditis, empyema\& autoimmune diseases\& liver cirrhosis\& children receiving immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Asses the nutritional status of the children with congenital heart disease
Time frame: Baseline
Adopt a protocol to avoid nutritional deficiency and achieve the normal growth in children with congenital heart disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
1. Asses the nutritional status of the children with congenital heart disease (time frame: Baseline). 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 Jun 2023.