Study on the Construction & Application of Breastfeeding Behavior

Status Recruiting

Clinical Trial Summary

This study is a randomized block trial designed to evaluate the effectiveness of a breastfeeding behavioural intervention program for mothers of infants with congenital heart disease (CHD). The purpose of this study is to compare exclusive breastfeeding rates, changes in weight-for-age z-scores (ΔWAZ) and height-for-age z-scores (ΔHAZ), and maternal breastfeeding behaviour between the intervention group and the control group at 1, 3, and 6 months of age.

Clinical Trial Description

Congenital heart disease (CHD) refers to an abnormality in the development of the heart and major blood vessels during fetal development. The prevalence of CHD in China is 8.94 per 1,000 live births and poses a significant public health concern for children's well-being. Infants with CHD often suffer from fluid restriction, nausea, belching, choking and stuttering due to structural changes in the heart and abnormal haemodynamics, which pose a challenge to their nutritional intake. The World Health Organization (WHO) advises that breastfeeding is the best way to nourish infants. Breastfeeding should begin within one hour of birth, and exclusive breastfeeding means that no other food or liquid, including water, should be continued for the first six months of life. The Expert Consensus on Nutritional Support for Children with Congenital Heart Disease recommends breast milk as the optimal nutrition for newborns and encourages infants with CHD to breastfeed. While breastfeeding offers benefits such as immune system enhancement, improved nervous system development, and increased intelligence for infants with CHD, breastfeeding rates are low in this population and interruptions are frequent. A behaviour change program based on the behaviour change wheel will be implemented at the Children's Hospital of Fudan University to enhance breastfeeding behaviour in mothers of infants with CHD, with the aim of increasing the rate of exclusive breastfeeding in this population. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05961540
Study type	Interventional
Source	Children's Hospital of Fudan University
Contact	Ying Gu, Doctor
Phone	8618017590969
Email	guying0128@aliyun.com
Status	Recruiting
Phase	N/A
Start date	May 25, 2023
Completion date	May 30, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study on the Construction and Application of Breastfeeding Behavior Intervention Program for Mothers of Infants With Congenital Heart Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms