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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000002543 | Other Identifier | University hospital Medical Information Network |
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Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Bifidobacterium bifidum |
|
| Placebo | Placebo Comparator | Dextrin without Bifidobacterium bifidum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium bifidum supplementation | Dietary Supplement | Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postnatal day when enteral feeding exceeded at 100ml/kg/day | Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint. | From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth |
| Measure | Description | Time Frame |
|---|---|---|
| standard deviation(SD) scores of bodyweight(BW) and head circumference(HC) | BW gain/day, SD scores of BW and HC at discharge from NICU | For the duration of NICU stay, an expected average of 3 months |
| Necrotizing enterocolitis or sepsis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satoshi Kusuda, MD | Tokyo Women's Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Women's Medical Unversity | Shinjuku | Tokyo | 162-8666 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37493095 | Derived | Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6. | |
| 33058137 | Derived | Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5. |
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| Placebo contains dextrin | Dietary Supplement | 0.5 of dextrin |
|
The incidences of necrtizing enterocolitis or sepsis during the stay in NICU
| For the duration of NICU stay, an expected average of 3 months |
| Intestinal flora | Intestinal flora during the stay in NICU | For the duration of NICU stay, an expected average of 3 months |