Growth and Development of Children With Congenital Heart Disease (CHD) (CHD)

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.

Study Overview

• Status: Completed
• Conditions: Researcher-Subject Relations
• Intervention / Treatment: Other: family-centered nutrition education

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • Çukurova Üniversitesi Balcalı Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group 1: Orally Fed Group Receiving Individualized Nutrition Education; 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.	Other: family-centered nutrition education; 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.
Experimental: Experimental Group 2: Nutrition Education Plus Nutritional Support Group; 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.	Other: family-centered nutrition education; 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.
No Intervention: control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	every weeek up to 1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	every weeek up to 1 months

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: EMEL YÜRÜK, ÇUKUROVA ÜNİVERİSTESİ

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Family Centered Care; Growth and Development; Child Health and Nursing; İndividual Nutrition Education.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: Adana Cukurova University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No