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

NCT05961540 | Completed

• 1 other identifier: CHFudan
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital; Breast Feeding

Keywords

Heart Defects, Congenital; Breast Feeding; Infant, Newborn; Feeding intervention

Outcome Measures

Primary Outcomes (3)

• Exclusive breastfeeding rate

  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%.

  At the age of 1month

• Exclusive breastfeeding rate

  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%.

  At the age of 3 months

• Exclusive breastfeeding rate

  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%.

  At the age of 6 months

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

Conventional care group

OTHER

The management of infants with CHD and their mothers is based on the current breastfeeding process and care protocols at the Cardiovascular Centre of the Children's Hospital of Fudan University.

Other: Conventional care

Breastfeeding intervention program

EXPERIMENTAL

Implement intervention programs to improve breastfeeding behaviour among mothers of infants with CHD and observe ongoing changes.

Behavioral: Breastfeeding behavioural intervention for mothers of infants with CHD

Interventions

Conventional care OTHER

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).

Conventional care group

Breastfeeding behavioural intervention for mothers of infants with CHD BEHAVIORAL

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.

Breastfeeding intervention program

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Breast Feeding

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Feeding Behavior; Behavior

Study Officials

• Ying Gu, Doctor

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 27, 2023
• Study Start: April 25, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 30, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

CN (1)