Image

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

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

Non Recruiting
1-6 years
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

Inclusion Criteria:

  • 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.
        Exclusion Criteria:
          -  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.

Study details
    Heart Defects
    Congenital
    Breast Feeding

NCT05961540

Children's Hospital of Fudan University

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.