Back to resultsGrowth and Development of Children With Congenital Heart Disease (CHD) (CHD)
Primary Purpose
Researcher-Subject Relations
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
family-centered nutrition education
Sponsored by
About this trial
This is an interventional supportive care trial for Researcher-Subject Relations focused on measuring Child Health and Nursing, Congenital Heart Disease, Family Centered Care, Growth and Development, İndividual Nutrition Education.
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Sites / Locations
- Çukurova Üniversitesi Balcalı Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
oral nutrition only group that received nutrition education
group that received nutrition education and fed with nutritional support
control group
Arm Description
This group consists of children who are fed orally according to their chronological age. The questionnaire form developed by the researcher and the parameters used in the evaluation of growth (height, head and chest circumference measurement) and Ankara Development Screening Inventory (AGTE) will be applied to the child and his / her family included in the specified group. Nutrition education prepared by the researcher will be given to the mothers of the children included in this group. After the nutrition training given to their mothers, the growth and development monitoring parameters of the child, body weight, height, head and chest circumference, will be repeated at regular intervals. Ankara Development Screening Inventory (AGTE) will be applied. The follow-up frequency of the hospitalized child after the operation will be determined and the measurements will be checked.
This group consists of children who receive nutritional support provided by oral food supplements, oral food supplements, enteral tube feeding and / or parenteral nutrition. The questionnaire form developed by the researcher and the parameters used in the evaluation of growth (height, head and chest circumference measurement) and Ankara Development Screening Inventory (AGTE) will be applied to the child and his / her family included in the specified group. Nutrition education prepared by the researcher will be given to the mothers of the children included in this group. After the nutrition training given to their mothers, the growth and development monitoring parameters of the child, body weight, height, head and chest circumference, will be repeated at regular intervals. Ankara Development Screening Inventory (AGTE) will be applied. The follow-up frequency of the child hospitalized after the operation will be determined and the measurements will be checked.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04903964
Brief Title
Growth and Development of Children With Congenital Heart Disease (CHD)
Acronym
CHD
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Researcher-Subject Relations
Keywords
Child Health and Nursing, Congenital Heart Disease, Family Centered Care, Growth and Development, İndividual Nutrition Education.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The research is a randomized controlled experimental study.
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral nutrition only group that received nutrition education
Arm Type
Experimental
Arm Description
This group consists of children who are fed orally according to their chronological age. The questionnaire form developed by the researcher and the parameters used in the evaluation of growth (height, head and chest circumference measurement) and Ankara Development Screening Inventory (AGTE) will be applied to the child and his / her family included in the specified group. Nutrition education prepared by the researcher will be given to the mothers of the children included in this group. After the nutrition training given to their mothers, the growth and development monitoring parameters of the child, body weight, height, head and chest circumference, will be repeated at regular intervals. Ankara Development Screening Inventory (AGTE) will be applied. The follow-up frequency of the hospitalized child after the operation will be determined and the measurements will be checked.
Arm Title
group that received nutrition education and fed with nutritional support
Arm Type
Experimental
Arm Description
This group consists of children who receive nutritional support provided by oral food supplements, oral food supplements, enteral tube feeding and / or parenteral nutrition. The questionnaire form developed by the researcher and the parameters used in the evaluation of growth (height, head and chest circumference measurement) and Ankara Development Screening Inventory (AGTE) will be applied to the child and his / her family included in the specified group. Nutrition education prepared by the researcher will be given to the mothers of the children included in this group. After the nutrition training given to their mothers, the growth and development monitoring parameters of the child, body weight, height, head and chest circumference, will be repeated at regular intervals. Ankara Development Screening Inventory (AGTE) will be applied. The follow-up frequency of the child hospitalized after the operation will be determined and the measurements will be checked.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
family-centered nutrition education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight measurement of growth parameter
Description
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.
Time Frame
every weeek up to 1 months
Secondary Outcome Measure Information:
Title
Height measurement of growth parameter
Description
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.
Time Frame
every weeek up to 1 months
Title
Head circumference measurement of growth parameters
Description
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.
Time Frame
every weeek up to 1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMEL YÜRÜK
Organizational Affiliation
ÇUKUROVA ÜNİVERİSTESİ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Çukurova Üniversitesi Balcalı Hastanesi
City
Adana
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
planned to be completed as a thesis
IPD Sharing Time Frame
When the thesis research is finished, it will be used for publication as an article publication
IPD Sharing Access Criteria
2 year
IPD Sharing URL
https://www.cbs.dk/en/research/cbs-research-profile/research-data-management/research-data-management-plans
Learn more about this trial
Growth and Development of Children With Congenital Heart Disease (CHD)
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