Clinical trial NCT05961540: Study on the Construction and Application of Breastfeeding Behavior Intervention Program for Mothers of Infants With Congenital Heart Disease
Official title: Study on the Construction and Application of Breastfeeding Behavior Intervention Program for Mothers of Infants With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Breast Feeding
Keywords: Heart Defects, Congenital
Breast Feeding
Infant, Newborn
Feeding intervention
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 68
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exclusive breastfeeding rate
timeFrame: At the age of 1month
measure: Exclusive breastfeeding rate
timeFrame: At the age of 3 months
measure: Exclusive breastfeeding rate
timeFrame: At the age of 6 months
Secondary outcomes:
measure: Breastfeeding Behavior Questionnaire for Mothers of Infants with CHD
timeFrame: At baseline and at 6 months of age.
measure: ΔWAZ at 1 month of age compared to birth, separated into two groups.
timeFrame: At the age of 1month
measure: ΔWAZ at 3 months of age compared to birth, separated into two groups.
timeFrame: At the age of 3 months
measure: ΔWAZ at 6 months of age compared to birth, separated into two groups.
timeFrame: At the age of 6 months
measure: ΔHAZ at 1 month of age compared to birth, separated into two groups.
timeFrame: At the age of 1 month
measure: ΔHAZ at 3 months of age compared to birth, separated into two groups.
timeFrame: At the age of 3 months
measure: ΔHAZ at 6 months of age compared to birth, separated into two groups.
timeFrame: At the age of 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Gu, Doctor
role: STUDY_DIRECTOR
References: