Trial | NCT04541771  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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 Started
Oct 31
2020
Anticipated
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Jan 31
2021
Anticipated
Last Update
Sep 09
2020

Drug 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

Drug Placebo

expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds

drug group Experimental

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

control group Placebo Comparator

this group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed

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
No Results Posted