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)

oral nutrition only group that received nutrition education

EXPERIMENTAL

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.

Other: family-centered nutrition education

group that received nutrition education and fed with nutritional support

EXPERIMENTAL

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.

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.

group that received nutrition education and fed with nutritional support; oral nutrition only group that received nutrition education

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: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• 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: February 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: September 15, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

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)