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

Sepsis Clinical Trial

— NEC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04541771
• Other study ID #: CH&ICH
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2020
• Est. completion date: January 2021

Study information

• Verified date: September 2020
• Source: The Children Complex & The Institute of Child Health, Multan
• Contact: STabasum
• Phone: 03417236837
• Email: dr.sumeratabasum[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Sepsis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Children Complex & The Institute of Child Health, Multan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	sepsis	number of participants who developed sepsis proven by blood cultures before of after intervention	At time of addmission and 15 days after intervention