The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants
NCT ID: NCT04541771
Last Updated: 2020-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2020-10-31
2021-01-31
Brief Summary
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Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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drug group
The trial group will receive their usual feeds plus daily probiotic (Lactobacillus Reuteri DSM 17938) addition 1 drop/kg/dose(. minimum of 20 million live Lactobacillus Reuteri are present in One drop) twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
Lactobacillus Reuteri DSM 17938
The trial group will receive their usual feeds plus daily probiotic addition 1 drop/kg/dose twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
control group
this group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed
Placebo
expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds
Interventions
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Lactobacillus Reuteri DSM 17938
The trial group will receive their usual feeds plus daily probiotic addition 1 drop/kg/dose twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
Placebo
expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
28 Weeks
34 Weeks
ALL
Yes
Sponsors
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Children's Hospital and Institute of Child Health, Multan
OTHER_GOV
Responsible Party
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Dr Summera Tabasum
post-graduate resident
Principal Investigators
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summera tabasum
Role: PRINCIPAL_INVESTIGATOR
CH&ICH
Central Contacts
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Other Identifiers
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CH&ICH
Identifier Type: -
Identifier Source: org_study_id
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