Role of Probiotic Use in Outcomes of Premature Birth

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 20, 2023

Primary Completion Date

June 10, 2023

Study Completion Date

September 10, 2023

Conditions
Necrotizing Enterocolitis of Newborn
Interventions
BIOLOGICAL

probiotic

Probiotic or placebo administration will be started from the first feed of the infants. Infants in the probiotic group will receive five drops of oil-based suspension containing 1×108 colony-forming units of L reuteri (DSM 17938 Biogaia AB, Stockholm, Sweden) once a day, until death or discharge from the hospital. For infants on oral feeds, after suctioning oral secretions, five drops will be placed in the posterior oropharynx of the infants. For infants without per oral feeds, five drops will be administered through a gastric tube followed by a flash of 0.5 mL of sterile water. For the infants in the placebo group, five drops from an identical vial containing only oil base will be administered following the same protocol as the probiotic group.

OTHER

placebo

Probiotic or placebo administration will be started from the first feed of the infants. Infants in the probiotic group will receive five drops of oil-based suspension containing 1×108 colony-forming units of L reuteri (DSM 17938 Biogaia AB, Stockholm, Sweden) once a day, until death or discharge from the hospital. For infants on oral feeds, after suctioning oral secretions, five drops will be placed in the posterior oropharynx of the infants. For infants without per oral feeds, five drops will be administered through a gastric tube followed by a flash of 0.5 mL of sterile water. For the infants in the placebo group, five drops from an identical vial containing only oil base will be administered following the same protocol as the probiotic group.

Trial Locations (1)

54610

services hospital Pakistan, Lahore

All Listed Sponsors
collaborator

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

lead

University of Health Sciences Lahore

OTHER