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| ID | Type | Description | Link |
|---|---|---|---|
| Agha Khan | Other Grant/Funding Number | Agha Khan |
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The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.
: In the last five years, many systematic reviews have shown the benefit of Probiotics in prevention of NEC and Sepsis in preterm babies but most of these studies have been done in the developed countries. Although the overall benefit has been tilted In favor of use of probiotic however a definitive consensus has not been reached due to inconsistencies in results. Moreover, the impact of multistrain probiotics in our particular population has not been studied, which provides the rationale for our research
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group - Intervention | Active Comparator | This group will receive intervention |
|
| Placebo | Placebo Comparator | This group will receive 10% DW |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Drug | All preterm babies <34 weeks Gestational age admitted within 24 hrs of life will be eligible for the study. Those full filling inclusion criteria and consenting to participate will be recruited. Consent will be obtained by team not caring for the patient. Each recruited patient will be assigned a case ID number. Based on the Randomization babies will be assigned to either the intervention group or control group. Study group: Multistrain probiotic containing a mix of Lactobacillus and Bifidobacterium spp.
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who develop NEC on probiotic vs placebo | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
• Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romisa Rehman, MBBS, FCPS | Contact | +923219059305 | measa_awan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Romisa Romisa, MBBS, FCPS | Hyatabad Medical Complex | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28274256 | Result | Pammi M, Cope J, Tarr PI, Warner BB, Morrow AL, Mai V, Gregory KE, Kroll JS, McMurtry V, Ferris MJ, Engstrand L, Lilja HE, Hollister EB, Versalovic J, Neu J. Intestinal dysbiosis in preterm infants preceding necrotizing enterocolitis: a systematic review and meta-analysis. Microbiome. 2017 Mar 9;5(1):31. doi: 10.1186/s40168-017-0248-8. |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
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| 10% dextrose | Drug | This will receive 10% DW as placebo |
|
|
| D007410 |
| Intestinal Diseases |
| D019602 |
| Food and Beverages |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |