Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-29 @ 5:01 PM
Study NCT ID:
NCT06970535
Status:
WITHDRAWN
Last Update Posted:
2025-05-14
First Post:
2025-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born Infants
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born Infants
Status:
WITHDRAWN
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pandemic related complications made the study no longer feasible.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An increasing number of children are developing non-communicable diseases that carry immediate and long-term significant societal and economic impacts. Thus, its prevention is imperative with early interventions, such as those that may fall within the first 1000 days, likely to yield better outcomes. The first 1000 days of life represent a period of rapid development sensitive to influences that may be leveraged to promote healthy growth. Breastfeeding is one such modifiable factor. Observational studies have shown that breastfeeding may be associated with reductions in chronic conditions, though its mechanism remains unknown. The complexity of these relationships is furthered by studies showing maternal metabolic status may alter breastmilk composition. Accordingly, this study aims to evaluate the influence of maternal metabolic status on breastmilk composition and assess associations between breastmilk composition and common noncommunicable diseases in childhood.
Detailed Description:
This project will be completed within TARGet Kids! (The Applied Research Group for Kids), a paediatric primary care research network (NCT01869530). Mother-infant dyads will be recruited and a breastmilk sample obtained at three months of age. Children will then be seen as part of routine care for the next five years to track growth, health and development. This study will provide the opportunity of prospectively following term-born Canadian children to understand the relationship between breastfeeding patterns and child health, its potential underlying mechanisms and how breastmilk composition is modified by maternal metabolic status, which altogether can be used to help set children on optimal developmental trajectories.
STUDY OBJECTIVES:
1. To evaluate the influence of maternal metabolic status, on breastmilk composition (energy, macronutrient and micronutrient content and microbial profile) at three months post-partum.
* Maternal metabolic status will be characterized by: maternal obesity (measured), diabetes, hypertension and gestational weight gain (self-reported).
2. To assess the associations between breastmilk composition and obesity, asthma and allergy in the children longitudinally to five years of age.
STUDY OBJECTIVES:
1. To evaluate the influence of maternal metabolic status, on breastmilk composition (energy, macronutrient and micronutrient content and microbial profile) at three months post-partum.
* Maternal metabolic status will be characterized by: maternal obesity (measured), diabetes, hypertension and gestational weight gain (self-reported).
2. To assess the associations between breastmilk composition and obesity, asthma and allergy in the children longitudinally to five years of age.
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?: