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

NCT04903964 | Completed

• 1 other identifier: Adana Cukurova University
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Researcher-Subject Relations

Keywords

Child Health and Nursing; Congenital Heart Disease; Family Centered Care; Growth and Development; İndividual Nutrition Education.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Height measurement of growth parameter

  every weeek up to 1 months

• Head circumference measurement of growth parameters

  every weeek up to 1 months

Study Arms (3)

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.

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.

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.

Interventions

family-centered nutrition education OTHER

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 Group 1: Orally Fed Group Receiving Individualized Nutrition Education; Experimental Group 2: Nutrition Education Plus Nutritional Support Group

Eligibility Criteria

• Age: 30 Days - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• years old,
• The children and their families who were followed up in the post-operative service were included.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova Üniversitesi Balcalı Hastanesi

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• EMEL YÜRÜK

  ÇUKUROVA ÜNİVERİSTESİ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The research is a randomized controlled experimental study.

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 27, 2021
• Study Start: January 20, 2021
• Primary Completion: July 15, 2021
• Study Completion: September 15, 2021
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: When the thesis research is finished, it will be used for publication as an article publication
• Access Criteria: 2 year

Locations

TU (1)