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| Name | Class |
|---|---|
| University Hospital Virgen de las Nieves | OTHER |
| Hospital Regional de Malaga | OTHER |
| Hospital of Jaen | OTHER |
| Hospital Costa del Sol |
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The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose of probiotic mixture | Experimental | A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains |
|
| Low dose of probiotic mixture | Experimental | A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose group | Dietary Supplement | A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of necrotizing enterocolitis and all-cause mortality | The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups. | From birth until three months |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal colonization by administered strains | From birth until three months | |
| Incidence of Late Onset Sepsis | Incidence of Late Onset Sepsis. In accordance with the criteria used by the Castrillo Group for neonatal infections in Spain (compatible clinical symptoms, elevation of water-phase reactants and positive blood culture) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de las Nieves | Granada | 18012 | Spain |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| OTHER |
| Hospital Universitario Torrecárdenas | OTHER |
| Hospital Universitario Virgen Macarena | OTHER |
| Complejo Hospitalario de Especialidades Juan Ramón Jimenez | OTHER |
| Hospital Universitario de Valme | OTHER |
| Hospitales Universitarios Virgen del Rocío | OTHER |
| Hospital Universitario Puerta del Mar | OTHER |
| Hospital General Universitario Santa Lucia | OTHER |
| Hospital del SAS de Jerez | OTHER |
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|
| Low dose group | Dietary Supplement | A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains |
|
| From birth until three months |
| Time to complete enteral nutrition | Time to reach complete enteral nutrition 140 ml/kg/day | From birth until three months |
| Days of Central Vascular Catheter | From birth until three months |
| Length of hospital stay | Days of hospital stay | From birth until three months |
| Weight change | From birth until three months |
| Incidence of Bronchopulmonary Dysplasia | From birth until three months |
| Incidence of patent ductus arteriosus | From birth until three months |
| D000091642 | Urogenital Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |