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It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New human milk fortifier | Experimental | New human milk fortifier |
|
| Currently marketed fortifier | Active Comparator | Currently marketed fortifier |
|
| New human milk fortifier with new Ca source | Experimental | a subgroup of patients will receive the new milk fortifier containing a new source of calcium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human milk fortifier | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day. | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR de la Citadelle | Liège | 4000 | Belgium | |||
| Hôpital des Enfants - CHU Pellegrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28727654 | Derived | Rigo J, Hascoet JM, Billeaud C, Picaud JC, Mosca F, Rubio A, Saliba E, Radke M, Simeoni U, Guillois B, de Halleux V, Jaeger J, Ameye L, Hays NP, Spalinger J. Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Oct;65(4):e83-e93. doi: 10.1097/MPG.0000000000001686. |
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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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| Bordeaux |
| 33000 |
| France |
| CHU Caen | Caen | 14033 | France |
| CHU Grenoble | Grenoble | 38043 | France |
| Hôpital de la Croix-Rousse | Lyon | 69317 | France |
| Hôpital de la Conception Marseille | Marseille | 13005 | France |
| Maternité Régionale | Nancy | 54042 | France |
| Hôpital Clocheville Tours | Tours | 37000 | France |
| Klinikum Ernest von Bergmann | Potsdam | 14467 | Germany |
| Policlinico Mangiagalli e Regina Elena | Milan | 20122 | Italy |
| Kinderspital | Lucerne | 6000 | Switzerland |
| D000091642 | Urogenital Diseases |