Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor cancelled study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - AA Formula with DHA and ARA | Other | Marketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA) |
|
| Arm 2 - AA Formula with alternative levels of DHA and ARA | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acid-based Formula with high DHA and ARA | Other |
| ||
| Amino Acid-based Formula with lower DHA and ARA |
| Measure | Description | Time Frame |
|---|---|---|
| Level of fatty acids in whole blood of infants | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | 4 months | |
| Occurrence of allergic manifestations | 4 months | |
| Occurrence of adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nikhil Thapar, M.D. | UCL Institute of Child Health and Great Ormond Street Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormand Street Hospital and Institute of Child Health | London | United Kingdon | WC1N1EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33006765 | Derived | Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| 4 months |
| Incidence of gas | 4 months |
| Incidence of fussiness | 4 months |
| Stool characteristics | 4 months |
| Body length | 4 months |
| Head Circumference | 4 months |
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided