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The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.
In this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including BSSL or pasteurized breast milk without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhBSSL | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhBSSL | Drug | 0.15 g/L rhBSSL added to pasteurized breast milk; one week treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of Fat Absorption measured in stool | Stool collected for a 72-hour period during the final 3 days of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in length and body weight | Baseline and after one week of treatment |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Timdahl, MD | Biovitrum AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital de la Croix Rousse | Lyon | France | ||||
| Hopital la Conception, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25222806 | Derived | Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vagero M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365. |
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| Placebo | Drug | One week treatment |
|
| Marseille |
| France |
| Maternité A. Pinard, Néonatologie | Nancy | France |
| Hopital Saint Vincent de Paul | Paris | France |
| Hopital des Enfants | Toulouse | France |
| CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville | Tours | France |
| Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi" | Ancona | Italy |
| Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria | Padova | Italy |