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

Children's Hospital and Institute of Child Health, Multan

Status and phase: Unknown; Phase 2

Conditions: Necrotizing Enterocolitis; Sepsis

Treatments: Drug: Lactobacillus Reuteri DSM 17938; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04541771

CH&ICH

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 28 to 34 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

drug group

Experimental 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

Treatment:

Drug: Lactobacillus Reuteri DSM 17938

control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo