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

Phase 2

• Conditions: Necrotizing Enterocolitis; Sepsis
• Interventions: Drug: Lactobacillus Reuteri DSM 17938; Drug: Placebo

• Registration Number: NCT04541771
• Lead Sponsor: Children's Hospital and Institute of Child Health, Multan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-07
• Last Update Submitted: 2020-09-07
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-09
• Study Start: 2020-10
• Primary Completion: 2020-12
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug group	Lactobacillus Reuteri DSM 17938	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	this group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed

Primary Outcome Measures

Name	Time	Method
narcotizing enterocolitis	up to 35 weeks of gestation	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

Secondary Outcome Measures

Name	Time	Method
sepsis	At time of addmission and 15 days after intervention	number of participants who developed sepsis proven by blood cultures before of after intervention