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

Researcher-Subject Relations Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903964
• Other study ID #: Adana Cukurova University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: July 2022
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 surgery for CHD on their growth and development.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 15, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Days to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases
• Researcher-Subject Relations

Intervention

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.

Locations

Country	Name	City	State
Turkey	Çukurova Üniversitesi Balcali Hastanesi	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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