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

NCT04541771 | Unknown Phase 2 DMC

• 1 other identifier: CH&ICH
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

Necrotizing Enterocolitis; Sepsis

Keywords

Necrotizing Enterocolitis,; lactobacillus reuteri ds 17938

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• sepsis

  At time of addmission and 15 days after intervention

Study Arms (2)

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

Drug: Lactobacillus Reuteri DSM 17938

control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lactobacillus Reuteri DSM 17938 DRUG

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 group

Placebo DRUG

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

control group

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonate\< 34 weeks and \>28 weeks of gestation of both genders Hemodynamically stable

You may not qualify if:

• Preterm neonates \>34 weeks gestational age \< 28 weeks of gestation Cardiorespiratory illness Parental refusal

Sponsors & Collaborators

• Children's Hospital and Institute of Child Health, Multan: lead

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Sepsis

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• summera tabasum

  CH&ICH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

STabasum

CONTACT

03417236837; dr.sumeratabasum@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post-graduate resident

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: September 9, 2020
• Study Start: October 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09