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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-A00062-49 | Other Identifier | DIRECTION GENERALE DE LA SANTE |
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The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maltodextrin | Placebo Comparator | Maltodextrin |
|
| Probiotic B lactis/B longum | Active Comparator | Bifidobacterium lactis + Bifidobacterium longum |
|
| Probiotic B longum | Active Comparator | Bifidobacterium longum |
|
| Probiotic B lactis | Active Comparator | Bifidobacterium lactis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic supplementation | Dietary Supplement | 1 capsule per day, from inclusion to 4 or 6 weeks after inclusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight (g) | From 4 to 6 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | measured by:
| between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period) |
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Inclusion criteria
Non inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Charles Picaud, Pr | Hôpital de la Croix-Rousse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Nénatologie, Hôpital Femme Mère Enfant | Bron | 69678 | France | |||
| Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26220763 | Derived | Hays S, Jacquot A, Gauthier H, Kempf C, Beissel A, Pidoux O, Jumas-Bilak E, Decullier E, Lachambre E, Beck L, Cambonie G, Putet G, Claris O, Picaud JC. Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study. Clin Nutr. 2016 Aug;35(4):802-11. doi: 10.1016/j.clnu.2015.06.006. Epub 2015 Jul 16. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Lyon |
| 69317 |
| France |
| Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| D000091642 | Urogenital Diseases |