NCT05961540

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Day – 6 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Defects, Congenital
• Breast Feeding

Interventions

Type	Name	Description
OTHER	Conventional care	1. Instruct parents to follow up with the baby at the doctor's appointment. 2. Provide telephone follow-up visits at 1 month, 3 months, and 6 months of age to assess the baby's feeding and physical development (height and weight).
BEHAVIORAL	Breastfeeding behavioural intervention for mothers of infants with CHD	Based on the Behavioural Change Wheel theory,the intervention program is developed and implemented to promote the change in breastfeeding behavior of mothers with CHD infants,so as to improve the exclusive breastfeeding rate of this population.Specific programs include: 1. Evaluate signs of hunger and satiety in infants. 2. Family visits, face-to-face guidance on breastfeeding skills, breast milk storage and management. 3. Training methods for promoting breast milk secretion. 4. To explain common feeding difficulties manifestations and treatment methods in infants with CHD. 5. Establish a breastfeeding promotion alliance. 6. Teach mothers to weigh their babies before and after breastfeeding to determine breast milk intake. 7. Assess and guide the growth and development of infants with CHD.

Timeline

• Start date: 2023-04-25
• Primary completion: 2024-03-01
• Completion: 2024-05-30
• First posted: 2023-07-27
• Last updated: 2024-07-17

Locations

1 site across 1 country: China