Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475521
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-21
Brief Title:
A Randomised Controlled Double-blinded Multi-country Multi-centre Trial to Study Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants
Sponsor:
Nutricia Research
Organization:
Nutricia Research
Study Overview
Official Title:
A Randomised Controlled Double-blinded Multi-country Multi-centre Trial to Study Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
GAIA
Brief Summary:
To demonstrate growth equivalence of a Baby formula Test Product when compared to the Control product after 16 weeks And to demonstrate better neurocognitive development at 52 weeks post-baseline in subjects receiving the Test Product compared to subjects receiving the Control Product Also other anthropometric parameters will be investigated up to 52 weeks
A Breastfed reference group exclusively breastfed for at least 16 weeks will also be included
A Breastfed reference group exclusively breastfed for at least 16 weeks will also be included
Detailed Description:
None
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