search
Back to results

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

Primary Purpose

Heart Defects, Congenital, Breast Feeding

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional care
Breastfeeding behavioural intervention for mothers of infants with CHD
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Defects, Congenital focused on measuring Heart Defects, Congenital, Breast Feeding, Infant, Newborn, Feeding intervention

Eligibility Criteria

1 Day - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Conventional care group

Breastfeeding intervention program

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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%.
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%.
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%.

Secondary Outcome Measures

Breastfeeding Behavior Questionnaire for Mothers of Infants with CHD
This questionnaire was created by us with a total of 21 items, which include five dimensions of breastfeeding behavior of mothers of CHD infants: mothers' attention to breastfeeding of children with congenital heart disease, identification of signals of hunger and satiety of infants, breastfeeding skills, methods to promote lactation, and identification and treatment of choking milk during breastfeeding of CHD infants. The questionnaire uses the Likert5-level scoring method, with a score of 0-105. The higher the score, the better the breastfeeding behavior of CHD infant mothers.
ΔWAZ at 1 month of age compared to birth, separated into two groups.
The infant's family has created their own digital scale that is as precise as the one used in the hospital. The weight measurement is accurate to 0.01 kilograms. For accurate measurement, it is recommended to weigh the baby at the age of one month in the early morning. Before measuring, the baby scale should be reset to zero, and the baby should be undressed in clothes and diapers. The baby's weight will be converted to WAZ. The WAZ at the age of 1 month minus the WAZ converted from birth weight is the ΔWAZ at the age of 1 month after birth.
ΔWAZ at 3 months of age compared to birth, separated into two groups.
The infant's family has created their own digital scale that is as precise as the one used in the hospital. The weight measurement is accurate to 0.01 kilograms. For accurate measurement, it is recommended to weigh the baby at 3 months of age in the early morning. Before measuring, the baby scale should be reset to zero, and the baby should be undressed in clothes and diapers. The baby's weight will be converted to WAZ. The WAZ at the age of 3 months minus the WAZ converted from birth weight is the ΔWAZ at the age of 3 months after birth.
ΔWAZ at 6 months of age compared to birth, separated into two groups.
The infant's family has created their own digital scale that is as precise as the one used in the hospital. The weight measurement is accurate to 0.01 kilograms. For accurate measurement, it is recommended to weigh the baby at 6 months of age in the early morning. Before measuring, the baby scale should be reset to zero, and the baby should be undressed in clothes and diapers. The baby's weight will be converted to WAZ. The WAZ at the age of 6 months minus the WAZ converted from birth weight is the ΔWAZ at the age of 6 months after birth.
ΔHAZ at 1 month of age compared to birth, separated into two groups.
The baby's family has prepared a height measuring tool that is as precise as the ones used in hospitals. The height measurement is within 0.1 centimeter accuracy. The baby's height should be measured early in the morning on the day when the baby is 1 month old. The baby's length will be converted into a HAZ. The HAZ at the age of 1 month minus the HAZ converted from birth length is the ΔHAZ at the age of 1 month after birth.
ΔHAZ at 3 months of age compared to birth, separated into two groups.
The baby's family has prepared a height measurement tool that is as precise as those used in hospitals. The height measurement is within 0.1 centimeter accuracy. The baby's height should be measured early in the morning on the day the baby is 3 months old. The baby's length will be converted into a HAZ. The HAZ at the age of 3 months minus the HAZ converted from birth length is the ΔHAZ at the age of 3 months after birth.
ΔHAZ at 6 months of age compared to birth, separated into two groups.
The baby's family has prepared a height measurement tool that is as precise as those used in hospitals. The height measurement is within 0.1 centimeter accuracy. The baby's height should be measured early in the morning on the day the baby is 6 months old. The baby's length will be converted into a HAZ. The HAZ at the age of 6 months minus the HAZ converted from birth length is the ΔHAZ at the age of 6 months after birth.

Full Information

First Posted
June 7, 2023
Last Updated
August 31, 2023
Sponsor
Children's Hospital of Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT05961540
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital, Breast Feeding
Keywords
Heart Defects, Congenital, Breast Feeding, Infant, Newborn, Feeding intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional care group
Arm Type
Other
Arm Description
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.
Arm Title
Breastfeeding intervention program
Arm Type
Experimental
Arm Description
Implement intervention programs to improve breastfeeding behaviour among mothers of infants with CHD and observe ongoing changes.
Intervention Type
Other
Intervention Name(s)
Conventional care
Intervention Description
Instruct parents to follow up with the baby at the doctor's appointment. 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).
Intervention Type
Behavioral
Intervention Name(s)
Breastfeeding behavioural intervention for mothers of infants with CHD
Intervention Description
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: Evaluate signs of hunger and satiety in infants. Family visits, face-to-face guidance on breastfeeding skills, breast milk storage and management. Training methods for promoting breast milk secretion. To explain common feeding difficulties manifestations and treatment methods in infants with CHD. Establish a breastfeeding promotion alliance. Teach mothers to weigh their babies before and after breastfeeding to determine breast milk intake. Assess and guide the growth and development of infants with CHD.
Primary Outcome Measure Information:
Title
Exclusive breastfeeding rate
Description
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%.
Time Frame
At the age of 1month
Title
Exclusive breastfeeding rate
Description
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%.
Time Frame
At the age of 3 months
Title
Exclusive breastfeeding rate
Description
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%.
Time Frame
At the age of 6 months
Secondary Outcome Measure Information:
Title
Breastfeeding Behavior Questionnaire for Mothers of Infants with CHD
Description
This questionnaire was created by us with a total of 21 items, which include five dimensions of breastfeeding behavior of mothers of CHD infants: mothers' attention to breastfeeding of children with congenital heart disease, identification of signals of hunger and satiety of infants, breastfeeding skills, methods to promote lactation, and identification and treatment of choking milk during breastfeeding of CHD infants. The questionnaire uses the Likert5-level scoring method, with a score of 0-105. The higher the score, the better the breastfeeding behavior of CHD infant mothers.
Time Frame
At baseline and at 6 months of age.
Title
ΔWAZ at 1 month of age compared to birth, separated into two groups.
Description
The infant's family has created their own digital scale that is as precise as the one used in the hospital. The weight measurement is accurate to 0.01 kilograms. For accurate measurement, it is recommended to weigh the baby at the age of one month in the early morning. Before measuring, the baby scale should be reset to zero, and the baby should be undressed in clothes and diapers. The baby's weight will be converted to WAZ. The WAZ at the age of 1 month minus the WAZ converted from birth weight is the ΔWAZ at the age of 1 month after birth.
Time Frame
At the age of 1month
Title
ΔWAZ at 3 months of age compared to birth, separated into two groups.
Description
The infant's family has created their own digital scale that is as precise as the one used in the hospital. The weight measurement is accurate to 0.01 kilograms. For accurate measurement, it is recommended to weigh the baby at 3 months of age in the early morning. Before measuring, the baby scale should be reset to zero, and the baby should be undressed in clothes and diapers. The baby's weight will be converted to WAZ. The WAZ at the age of 3 months minus the WAZ converted from birth weight is the ΔWAZ at the age of 3 months after birth.
Time Frame
At the age of 3 months
Title
ΔWAZ at 6 months of age compared to birth, separated into two groups.
Description
The infant's family has created their own digital scale that is as precise as the one used in the hospital. The weight measurement is accurate to 0.01 kilograms. For accurate measurement, it is recommended to weigh the baby at 6 months of age in the early morning. Before measuring, the baby scale should be reset to zero, and the baby should be undressed in clothes and diapers. The baby's weight will be converted to WAZ. The WAZ at the age of 6 months minus the WAZ converted from birth weight is the ΔWAZ at the age of 6 months after birth.
Time Frame
At the age of 6 months
Title
ΔHAZ at 1 month of age compared to birth, separated into two groups.
Description
The baby's family has prepared a height measuring tool that is as precise as the ones used in hospitals. The height measurement is within 0.1 centimeter accuracy. The baby's height should be measured early in the morning on the day when the baby is 1 month old. The baby's length will be converted into a HAZ. The HAZ at the age of 1 month minus the HAZ converted from birth length is the ΔHAZ at the age of 1 month after birth.
Time Frame
At the age of 1 month
Title
ΔHAZ at 3 months of age compared to birth, separated into two groups.
Description
The baby's family has prepared a height measurement tool that is as precise as those used in hospitals. The height measurement is within 0.1 centimeter accuracy. The baby's height should be measured early in the morning on the day the baby is 3 months old. The baby's length will be converted into a HAZ. The HAZ at the age of 3 months minus the HAZ converted from birth length is the ΔHAZ at the age of 3 months after birth.
Time Frame
At the age of 3 months
Title
ΔHAZ at 6 months of age compared to birth, separated into two groups.
Description
The baby's family has prepared a height measurement tool that is as precise as those used in hospitals. The height measurement is within 0.1 centimeter accuracy. The baby's height should be measured early in the morning on the day the baby is 6 months old. The baby's length will be converted into a HAZ. The HAZ at the age of 6 months minus the HAZ converted from birth length is the ΔHAZ at the age of 6 months after birth.
Time Frame
At the age of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Gu, Doctor
Phone
8618017590969
Email
guying0128@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Zhang, Master
Phone
8618917279219
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Gu, Doctor
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Gu, Doctor
Phone
13816881726
Email
guying0128@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs