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This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard infant formula | Placebo Comparator | Standard infant formula fed ad libitum |
|
| Standard infant formula with PL1 | Experimental | Standard infant formula enriched with PL1 lipid fraction fed ad libitum |
|
| Standard infant formula with PL2 | Experimental | Standard infant formula enriched with PL2 lipid fraction fed ad libitum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard infant formula | Other |
| ||
| Standard infant formula with PL1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean weight gain (g/day) | Enrollment to age 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude Billeaud, MD | Hôpital des enfants, CHU Pellegrin, Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Caen | Caen | Cedex 9 | 14033 | France | ||
| Hôpital Bretonneau - UPM |
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| Other |
|
| Standard infant formula with PL2 | Other |
|
| Tours |
| Cedex 9 |
| 37044 |
| France |
| Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France |
| Istituto di Ostetricia e Ginecologia Neonatalogia | Palermo | 90127 | Italy |