Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652698
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Early Supplementation for Cows Milk Allergy Prevention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Supplementation for Cows Milk Allergy Prevention in Breastfed Infants in Poland ESCAPE-PL a Protocol for Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCAPE-PL
Brief Summary:
Cows milk allergy CMA is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions risk of nutritional deficiencies social limitations and decreased quality of life It also represents a financial burden for families and healthcare resources
There is an ongoing debate about the significance of early exposure to cows milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life Current recommendations for early introduction of cows milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cows milk proteins and the development of CMA which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families
This trial aims to investigate whether early supplementation with various nutritional interventions cows milk formula CMF amino acids formula AAF donor human milk DHM or high-pressure processed pascalized donor human milk DHM-P could serve as an effective strategy for the primary prevention of CMA in breastfed neonates
This study is an open-label randomized controlled head-to-head trial with four parallel arms and allocation 1111
There is an ongoing debate about the significance of early exposure to cows milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life Current recommendations for early introduction of cows milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cows milk proteins and the development of CMA which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families
This trial aims to investigate whether early supplementation with various nutritional interventions cows milk formula CMF amino acids formula AAF donor human milk DHM or high-pressure processed pascalized donor human milk DHM-P could serve as an effective strategy for the primary prevention of CMA in breastfed neonates
This study is an open-label randomized controlled head-to-head trial with four parallel arms and allocation 1111
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None