Heart Defects, CongenitalNCT05961540
Study on the Construction and Application of Breastfeeding Behavior Intervention Program for Mothers of Infants With Congenital Heart Disease
A study testing Conventional care and Breastfeeding behavioural intervention for mothers of infants with CHD in people with Heart Defects, Congenital and Breast Feeding, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Heart Defects, Congenital, Breast Feeding
- What is being tested?
- Conventional care and Breastfeeding behavioural intervention for mothers of infants with CHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
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.
Read the 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.
- Conditions
- Heart Defects, Congenital, Breast Feeding
- Being tested
- Conventional care, Breastfeeding behavioural intervention for mothers of infants with CHD
- Keywords
- Heart Defects, Congenital, Breast Feeding, Infant, Newborn, Feeding intervention
- Medical subject headings
- Heart Defects, Congenital, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional careOther
- 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).
Breastfeeding behavioural intervention for mothers of infants with CHDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Conventional care |
| Breastfeeding intervention program | Experimental | Implement intervention programs to improve breastfeeding behaviour among mothers of infants with CHD and observe ongoing changes. Receives: Behavioral: Breastfeeding behavioural intervention for mothers of infants with CHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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%.
Measured: At the age of 6 months
Secondary outcomes (7)
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.
Measured: At baseline and at 6 months of age.
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.
Measured: At the age of 1month
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.
Measured: At the age of 3 months
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.
Measured: At the age of 6 months
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.
Measured: At the age of 1 month
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.
Measured: At the age of 3 months
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.
Measured: At the age of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start25 Apr 2023
- Primary completion1 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Gu, Doctor, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961540
- Sponsor's protocol ID
- CHFudan
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Construction and Application of Breastfeeding Behavior Intervention Program for Mothers of Infants With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05961540
- Acronym / sponsor ID
- CHFudan
- Conditions
- Heart Defects, Congenital, Breast Feeding
- Keywords
- Heart Defects, Congenital, Breast Feeding, Infant, Newborn, Feeding intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional care group | Other | Other: Conventional careThe 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. |
| Breastfeeding intervention program | Experimental | Behavioral: Breastfeeding behavioural intervention for mothers of infants with CHDImplement intervention programs to improve breastfeeding behaviour among mothers of infants with CHD and observe ongoing changes. |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional care1. 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). | Other | Conventional care group |
| Breastfeeding behavioural intervention for mothers of infants with CHDBased 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. | Behavioural | Breastfeeding intervention program |
Primary outcome
Exclusive breastfeeding rate
Time frame: At the age of 1month
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
Time frame: At the age of 3 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%.
Exclusive breastfeeding rate
Time frame: 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%.
7 secondary outcomes
Breastfeeding Behavior Questionnaire for Mothers of Infants with CHD
Time frame: At baseline and at 6 months of age.
ΔWAZ at 1 month of age compared to birth, separated into two groups.
Time frame: At the age of 1month
ΔWAZ at 3 months of age compared to birth, separated into two groups.
Time frame: At the age of 3 months
ΔWAZ at 6 months of age compared to birth, separated into two groups.
Time frame: At the age of 6 months
ΔHAZ at 1 month of age compared to birth, separated into two groups.
Time frame: At the age of 1 month
ΔHAZ at 3 months of age compared to birth, separated into two groups.
Time frame: At the age of 3 months
ΔHAZ at 6 months of age compared to birth, separated into two groups.
Time frame: At the age of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Gu, Doctor study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional care and Breastfeeding behavioural intervention for mothers of infants with CHD in people with Heart Defects, Congenital and Breast Feeding, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding rate (time frame: At the age of 1month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.