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

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Brief Title

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

Official Title

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

Brief Summary

      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
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

narcotizing enterocolitis

Secondary Outcome

 sepsis

Condition

Necrotizing Enterocolitis

Intervention

Lactobacillus Reuteri DSM 17938

Study Arms / Comparison Groups

 drug group
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

October 2020

Completion Date

January 2021

Primary Completion Date

December 2020

Eligibility Criteria

        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
      

Gender

All

Ages

28 Weeks - 34 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

summera tabasum, 03417236837, [email protected]



Administrative Informations


NCT ID

NCT04541771

Organization ID

CH&ICH


Responsible Party

Principal Investigator

Study Sponsor

The Children Complex & The Institute of Child Health, Multan


Study Sponsor

summera tabasum, Principal Investigator, CH&ICH


Verification Date

September 2020