Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05310396
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2022-01-04
Brief Title:
Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants a Randomized Controlled Intervention Study
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
Study Overview
Official Title:
Efficacy of a Nutrient Blend Comprised of Specific Nutrients in Improving Neurocognitive and Behavioural Outcomes in Infants a Randomized Controlled Intervention Study
Status:
ACTIVE_NOT_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:
None
Brief Summary:
The purpose of this study is to demonstrate the efficacy of the nutrient blend in a starter infant formula IF and follow up infant formula FUF in improving the neurocognitive and behavioural outcomes among formula-fed infants randomized to the experimental formula EF versus the control formula CF
Detailed Description:
This is a prospective randomized controlled double-blind 2-arm parallel-group clinical trial in the Philippines Subjects will be recruited from a single centre in case of insufficient recruitment more sites will be added to the study The clinical trial is composed of two parts a double-blind interventional period and a follow-up period The first period is the double-blind intervention phase from enrolment V1 until age 12 months V5 The intervention will be provided only during this double-blind phase The second period is a non-interventional follow-up period from age 12 months until age 24 months
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