Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961540
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2023-06-07
Brief Title:
Study on the Construction and Application of Breastfeeding Behavior Intervention Program for Mothers of Infants With Congenital Heart Disease
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
Study on the Construction and Application of Breastfeeding Behavior Intervention Program for Mothers of Infants With Congenital Heart Disease
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 894 per 1000 live births and poses a significant public health concern for childrens 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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None