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

NCT ID: NCT04903964

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-09-15

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.

Conditions

Researcher-Subject Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

oral nutrition only group that received nutrition education

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.

Group Type: EXPERIMENTAL

family-centered nutrition education

Intervention Type: 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.

group that received nutrition education and fed with nutritional support

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.

Group Type: EXPERIMENTAL

family-centered nutrition education

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Emel Yürük

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EMEL YÜRÜK

Role: PRINCIPAL_INVESTIGATOR

ÇUKUROVA ÜNİVERİSTESİ

Locations

Çukurova Üniversitesi Balcalı Hastanesi

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Adana Cukurova University

Identifier Type: -

Identifier Source: org_study_id