The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan. 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

Official Title
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The Role of Lactobacillus Reuteri (L. Reuteri) in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Less Than 34 Weeks of Gestation

Conditions
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Necrotizing Enterocolitis, Sepsis

Intervention / Treatment
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* Drug: Lactobacillus Reuteri DSM 17938
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm neonate< 34 weeks and >28 weeks of gestation of both genders Hemodynamically stable Exclusion Criteria: Preterm neonates >34 weeks gestational age < 28 weeks of gestation Cardiorespiratory illness Parental refusal

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants will be divided in two groups. one is control group and the other Interventional group. control group will receive the drug under study and control will be given placebo for the period of until they complete 35 weeks of gestation or discharged.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drug group<br>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 | Drug: Lactobacillus Reuteri DSM 17938<br>* 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<br>|
| Placebo Comparator: control group<br>this group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed | Drug: Placebo<br>* expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| narcotizing enterocolitis | number of participants with the sign of feeding intolerance (such as the gastric aspirate in the amount that was more than half of previous feeding), or with abdominal distension measured by increase in abdominal girth from base line,Bell Staging Criteria according to clinical and radio-logical signs | up to 35 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sepsis | number of participants who developed sepsis proven by blood cultures before of after intervention | At time of addmission and 15 days after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotizing Enterocolitis,, lactobacillus reuteri ds 17938