Study on the Construction and Application of Breastfeeding Behavior Intervention Program for Mothers of Infants With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Exclusive breastfeeding rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For infants
- •CHD was diagnosed within 14 days of birth.
- •From birth to 14 days old.
- •Exclusive breastfeeding or mixed feeding during enrollment.
- •For mothers
- •The mother is the primary caretaker for the infant with CHD.
- •The mother has a smartphone and has the skills to use it.
- •She has good reading and communication skills and can work fully with others.
- •In good physical health with no clear disability, such as severe cardiovascular disease, etc.
- •In good mental health, without any clearly diagnosed anxiety disorders, depression, etc.
- •Mothers must be at least 18 years old.
排除标准
- •For infants
- •Congenital anomalies such as gastrointestinal anomalies, facial anomalies, cleft lip and palate, and various syndromes due to chromosomal abnormalities are combined.
- •Cardiac surgery was performed within 14 days of birth.
- •The infant is not breastfed according to medical standards (for example, with galactosemia, phenylketonuria, or maple glycosuria).
- •For mothers
- •Mothers with mental illness, cognitive impairment, etc. who struggle to communicate effectively.
- •Those who have contraindications to breastfeeding, such as long-term use of specific types of drugs such as chemotherapy drugs, opioids, anti-epileptic drugs, anti-depressants, psychotropic drugs, etc.
- •Systemic infectious diseases during feeding include HIV positive, active or untreated tuberculosis, recent syphilis infection, etc.
结局指标
主要结局
Exclusive breastfeeding rate
时间窗: At the age of 6 months
The exclusive breastfeeding rate equals (the number of CHD infants who choose exclusive breastfeeding) divided by (the total number of CHD infants) multiplied by 100%.
次要结局
- Breastfeeding Behavior Questionnaire for Mothers of Infants with CHD(At baseline and at 6 months of age.)
- ΔWAZ at 1 month of age compared to birth, separated into two groups.(At the age of 1month)
- ΔWAZ at 3 months of age compared to birth, separated into two groups.(At the age of 3 months)
- ΔHAZ at 3 months of age compared to birth, separated into two groups.(At the age of 3 months)
- ΔWAZ at 6 months of age compared to birth, separated into two groups.(At the age of 6 months)
- ΔHAZ at 1 month of age compared to birth, separated into two groups.(At the age of 1 month)
- ΔHAZ at 6 months of age compared to birth, separated into two groups.(At the age of 6 months)