Researcher-Subject RelationsCHDNCT04903964
Growth and Development of Children With Congenital Heart Disease (CHD)
A study testing family-centered nutrition education in people with Researcher-Subject Relations, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had… Read more about this study
- Who is it for?
- Ages 30 days to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Researcher-Subject Relations
- What is being tested?
- family-centered nutrition education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2021to 15 Sep 2021
- 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 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Congenital heart disease,
- Born on time (38-42 weeks)
- Over 2.300 gr.
- fed with additional nutritional support to oral and oral nutrition,
- Decided to have surgery,
- 0-3 years old,
- The children and their families who were followed up in the post-operative service were included.
Who cannot join
- No congenital heart disease
- Not planned to have surgery,
- over 3 years old,
- Children with additional congenital malformation, dysmorphic syndrome, chromosomal disease, severe infection, hypothyroidism and similar disorders that may cause growth and development retardation were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Individualized Nutrition Training Given to the Families of Children With Congenital Heart Disease (CHD) in the Post-Operative Period on Their Growth and Development
The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.
Read the detailed description
The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.
The data of the study were collected at Çukurova University Medical Faculty Balcalı Hospital Cardiovascular Surgery between 20/01/2021-30/06/2021. The research was conducted by interviewing the families of 42 children with congenital heart disease. Personal information form, growth parameters and Ankara Developmental Screening Inventory were applied to three groups formed as two experimental and control groups by randomization method. Family-centered care and individualized nutrition training were applied to the first experimental group who was fed orally and and the second experimental group orally and nutritionally fed. These trainings were about nutritional contents suitable for the age of the baby, the way of preparing the food and meeting the calorie needs of the baby. No training was given to the control group during the research process. The growth and development parameters of all three groups were evaluated and the effect of education was examined.
- Conditions
- Researcher-Subject Relations
- Being tested
- family-centered nutrition education
- Keywords
- Child Health and Nursing, Congenital Heart Disease, Family Centered Care, Growth and Development, İndividual Nutrition Education.
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family-centered nutrition educationOther
There is a training program prepared by the researcher to increase the nutritional knowledge of mothers with children aged 0-3. The definition and importance of nutrition in the session, respectively, adequate and balanced nutrition, insufficient and unbalanced nutrition damages, grouping of nutrients, feeding 0--6 months old baby, feeding premature baby, breastfeeding, situations to be considered while breastfeeding, starting additional foods, 9-12 monthly baby nutrition, 1-3 years old child nutrition and nutritional nutrition support.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1: Orally Fed Group Receiving Individualized Nutrition Education | Experimental | This group consisted of children aged 0-3 years with congenital heart disease who were fed orally according to their age and clinical condition. A researcher-developed questionnaire, anthropometric growth measurements (body weight, height, head circumference, and chest circumference), and the Ankara Developmental Screening Inventory (ADSI/AGTE) were administered to the children and their families. Mothers received individualized family-centered nutrition education prepared by the researcher, including breastfeeding, complementary feeding, age-appropriate nutrition, and nutritional requirements after congenital heart surgery. Following the educational intervention, anthropometric measurements were repeated on postoperative day 1, day 7, and day 14 to evaluate growth outcomes. Developmental status was assessed using the Ankara Developmental Screening Inventory. Receives: Other: family-centered nutrition education |
| Experimental Group 2: Nutrition Education Plus Nutritional Support Group | Experimental | Arm/Group Description:
This group consisted of children aged 0-3 years with congenital heart disease who received individualized nutrition education in addition to nutritional support, including fortified breast milk, oral nutritional supplements, and/or enteral nutritional support according to their nutritional requirements. A researcher-developed questionnaire, anthropometric growth measurements (body weight, height, head circumference, and chest circumference), and the Ankara Developmental Screening Inventory (ADSI/AGTE) were administered to the children and their families. Mothers received individualized family-centered nutrition education prepared by the researcher. Following the intervention, anthropometric measurements were repeated on postoperative day 1, day 7, and day 14 to evaluate growth outcomes. Developmental status was assessed using the Ankara Developmental Screening Inventory. Receives: Other: family-centered nutrition education |
| control group | No intervention | While collecting research data on the specified dates; Comparison group (KG) will be selected as many as the number of volunteers who want to participate in the research. No nutritional attempt will be made to the child included in this group. The parameters used in the evaluation of growth (height, head and chest circumference measurement) and the Ankara Development Screening Inventory (AGTE) will be applied to children aged 0-3 who are followed up due to congenital heart disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight measurement of growth parameter
In order to determine the physical growth status of the babies, kilograms (in kg) will be measured by the researcher. These measurement results will be given as average Z scores ((kg) type and percentile values. Body weight is measured on an Oncomed electronic scale by removing the clothing and subtracting the dry weight of the ultra-prima brand diaper.
Measured: every weeek up to 1 months
Secondary outcomes (2)
Height measurement of growth parameter
Height (in cm) will be measured by the researcher to determine the physical growth status of the babies. These measurement results will be given as average Z-scores (cm) type and percentile values. For height measurement, a head-foot board (infantometer) with a measuring tape is used.
Measured: every weeek up to 1 months
Head circumference measurement of growth parameters
The head circumference (in cm) will be measured by the researcher to determine the physical growth state of the babies. These measurement results will be given as average Z scores (cm) type and percentile values. Head circumference measurement is made with an inelastic tape measure from the most protruding point of the occipital bone over the ear and over the line passing over the eyebrows.
Measured: every weeek up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start20 Jan 2021
- Primary completion15 Jul 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Researcher-Subject RelationsStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The research is a randomized controlled experimental study.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Yürük, Cukurova University
- Investigators
- EMEL YÜRÜK, Principal investigator, ÇUKUROVA ÜNİVERİSTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903964
- Sponsor's protocol ID
- Adana Cukurova University
- Acronym
- CHD
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned to be completed as a thesis
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Nutrition Training Given to the Families of Children With Congenital Heart Disease (CHD) in the Post-Operative Period on Their Growth and Development
- ClinicalTrials.gov ID
- NCT04903964
- Acronym / sponsor ID
- CHD / Adana Cukurova University
- Conditions
- Researcher-Subject Relations
- Keywords
- Child Health and Nursing, Congenital Heart Disease, Family Centered Care, Growth and Development, İndividual Nutrition Education.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 27 May 2021 (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.
The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.
Detailed description
The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.
The data of the study were collected at Çukurova University Medical Faculty Balcalı Hospital Cardiovascular Surgery between 20/01/2021-30/06/2021. The research was conducted by interviewing the families of 42 children with congenital heart disease. Personal information form, growth parameters and Ankara Developmental Screening Inventory were applied to three groups formed as two experimental and control groups by randomization method. Family-centered care and individualized nutrition training were applied to the first experimental group who was fed orally and and the second experimental group orally and nutritionally fed. These trainings were about nutritional contents suitable for the age of the baby, the way of preparing the food and meeting the calorie needs of the baby. No training was given to the control group during the research process. The growth and development parameters of all three groups were evaluated and the effect of education was examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The research is a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1: Orally Fed Group Receiving Individualized Nutrition Education | Experimental | Other: family-centered nutrition educationThis group consisted of children aged 0-3 years with congenital heart disease who were fed orally according to their age and clinical condition. A researcher-developed questionnaire, anthropometric growth measurements (body weight, height, head circumference, and chest circumference), and the Ankara Developmental Screening Inventory (ADSI/AGTE) were administered to the children and their families. Mothers received individualized family-centered nutrition education prepared by the researcher, including breastfeeding, complementary feeding, age-appropriate nutrition, and nutritional requirements after congenital heart surgery. Following the educational intervention, anthropometric measurements were repeated on postoperative day 1, day 7, and day 14 to evaluate growth outcomes. Developmental status was assessed using the Ankara Developmental Screening Inventory. |
| Experimental Group 2: Nutrition Education Plus Nutritional Support Group | Experimental | Other: family-centered nutrition educationArm/Group Description: This group consisted of children aged 0-3 years with congenital heart disease who received individualized nutrition education in addition to nutritional support, including fortified breast milk, oral nutritional supplements, and/or enteral nutritional support according to their nutritional requirements. A researcher-developed questionnaire, anthropometric growth measurements (body weight, height, head circumference, and chest circumference), and the Ankara Developmental Screening Inventory (ADSI/AGTE) were administered to the children and their families. Mothers received individualized family-centered nutrition education prepared by the researcher. Following the intervention, anthropometric measurements were repeated on postoperative day 1, day 7, and day 14 to evaluate growth outcomes. Developmental status was assessed using the Ankara Developmental Screening Inventory. |
| control group | No intervention | –While collecting research data on the specified dates; Comparison group (KG) will be selected as many as the number of volunteers who want to participate in the research. No nutritional attempt will be made to the child included in this group. The parameters used in the evaluation of growth (height, head and chest circumference measurement) and the Ankara Development Screening Inventory (AGTE) will be applied to children aged 0-3 who are followed up due to congenital heart disease. |
Who may qualify
- Ages
- 30 days to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Congenital heart disease,
- Born on time (38-42 weeks)
- Over 2.300 gr.
- fed with additional nutritional support to oral and oral nutrition,
- Decided to have surgery,
Key exclusion criteria (4 listed)
- No congenital heart disease
- Not planned to have surgery,
- over 3 years old,
- Children with additional congenital malformation, dysmorphic syndrome, chromosomal disease, severe infection, hypothyroidism and similar disorders that may cause growth and development retardation were excluded from the study.
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 |
|---|---|---|
| family-centered nutrition educationThere is a training program prepared by the researcher to increase the nutritional knowledge of mothers with children aged 0-3. The definition and importance of nutrition in the session, respectively, adequate and balanced nutrition, insufficient and unbalanced nutrition damages, grouping of nutrients, feeding 0--6 months old baby, feeding premature baby, breastfeeding, situations to be considered while breastfeeding, starting additional foods, 9-12 monthly baby nutrition, 1-3 years old child nutrition and nutritional nutrition support. | Other | Experimental Group 1: Orally Fed Group Receiving Individualized Nutrition Education, Experimental Group 2: Nutrition Education Plus Nutritional Support Group |
Primary outcome
Body weight measurement of growth parameter
Time frame: every weeek up to 1 months
In order to determine the physical growth status of the babies, kilograms (in kg) will be measured by the researcher. These measurement results will be given as average Z scores ((kg) type and percentile values. Body weight is measured on an Oncomed electronic scale by removing the clothing and subtracting the dry weight of the ultra-prima brand diaper.
2 secondary outcomes
Height measurement of growth parameter
Time frame: every weeek up to 1 months
Head circumference measurement of growth parameters
Time frame: every weeek up to 1 months
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 24 Jun 2026.
- Individual participant dataSharing planned: Yes. planned to be completed as a thesis
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.
EMEL YÜRÜK principal investigator
ÇUKUROVA ÜNİVERİSTESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing family-centered nutrition education in people with Researcher-Subject Relations, run by Cukurova University at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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 24 Jun 2026. 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 Turkey (Türkiye). 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?
Body weight measurement of growth parameter (time frame: every weeek up to 1 months). 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 24 Jun 2026.