Role of Probiotic Use in Outcomes of Premature Birth

NCT05710575 | Completed

• 1 other identifier: IRB/2022/920/SIMS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Project Summary: The prevalence of preterm birth ranges from 5% to 18% across 184 countries, and an estimated 15 million infants are born preterm globally. These infants with an immature immune system and gastrointestinal tract are at risk of complications of premature birth, which is the leading cause of neonatal death. According to researcher hypothesis for this study, there is role of probiotics in promoting food tolerance and reducing the incidence and severity of Necrotizing Enterocolitis (NEC) and death related to NEC in pre-term VLBW infants. In the current study, we will examine the effects of probiotics in premature infants and figure out the optimal intervention through randomized controlled trial (RCT). A prospective, masked, randomized single blinded controlled trial will be conducted in the neonatal intensive care unit (NICU) of Services Hospital Lahore. In this trial the treatment group will receive the probiotics during their first month of life, and the control group will receive no treatment. Primary outcome will be the incidence of death or NEC (≥ stage 2). Death is included as a primary outcome because it is a competing variable of NEC. The x2 test will be used to analyze the categorical data, along with Fisher's exact test when applicable. The Student's t test will be used for continuous data. A logistic regression model will be used to analyze the treatment effects on the primary and secondary outcome variables (death, NEC, and sepsis). Values will be expressed for mean and standard deviation. Statistical significance is set at P-value of 0.05. The objective of this study is to confirm the evidence and to get the more reliable and authentic results regarding the more effective treatment of NEC in preterm neonates. In this way, the researcher shall be able to improve the outcome of premature births and to reduce the complications by increasing the cure rate. Similarly, it will help the researcher to improve knowledge for better management of NEC in neonates.

Conditions

Necrotizing Enterocolitis of Newborn

Keywords

probiotic; premature birth

Outcome Measures

Primary Outcomes (2)

• number of participants who develop necrotizing enterocolitis

  necrotizing enterocolitis will be stage according to bell's staging

  1 month

• number of participants with prolonged hospital stay

  length of hospital stay from day of admission to day of discharge according to medical records

  1 month

Secondary Outcomes (2)

• number of participants with culture proven sepsis

  1 month

• number of participants with feeding intolerance

  1 month

Study Arms (2)

probiotic group

EXPERIMENTAL

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.

Biological: probiotic

placebo group

EXPERIMENTAL

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

Interventions

probiotic BIOLOGICAL

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.

probiotic group

placebo OTHER

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.

placebo group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants with gestational age of more than 28 weeks and less than 36 weeks
• Birth weight of 1000 - 2500 grams
• Admitted to the neonatal intensive care unit (NICU) of Pediatric Medicine Unit II, Services hospital Lahore
• With intestinal feeding.

You may not qualify if:

• Infants with major congenital malformations (including congenital heart disease, gastrointestinal obstruction, gastroschisis, etc.)
• Congenital metabolic errors hypoxic ischemic encephalopathy (HIE) of grade two or more according to Sarnat scoring system (Gordon et al., 2020)
• Death in the first 72 hours of life
• Newborns of addicted mothers
• Postpartum age more than two weeks
• Parental unacceptance

Sponsors & Collaborators

• University of Health Sciences Lahore: lead
• Services Institute of Medical Sciences, Pakistan: collaborator

Study Sites (1)

services hospital Pakistan

Lahore, Punjab Province, 54610, Pakistan

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• komal khadim hussain, MBBS

  Services Institute of Medical Sciences, Pakistan

  PRINCIPAL INVESTIGATOR

• dr azhar farooq, MBBS,FCPS

  Services Institute of Medical Sciences, Pakistan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will be carried out in blocks of 10, and the list of random numbers will be generated by the subprogram Epitable from Epi-Info 6.04 (Centers for Disease Control and Prevention, Atlanta, GA). Two trained external personnel from the NICU will be responsible for obtaining this list and for randomly assigning the infants to the probiotics and control groups. A sealed envelope with the identification number in ascending order, containing information about which group they belonged to, will be provided for each infant and will be sent to the hospital's nutritional center. Three previously trained research assistants, who will not be a part of the neonatal team, will interview the mothers, recruit the infants, and they will also be responsible for sending the envelopes to the nutritional unit.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Randomization will be carried out in blocks of 10, and the list of random numbers will be generated by the subprogram Epitable from Epi-Info 6.04 (Centers for Disease Control and Prevention, Atlanta, GA). Two trained external personnel from the NICU will be responsible for obtaining this list and for randomly assigning the infants to the probiotics and control groups. A sealed envelope with the identification number in ascending order, containing information about which group they belonged to, will be provided for each infant and will be sent to the hospital's nutritional center. Three previously trained research assistants, who will not be a part of the neonatal team, will interview the mothers, recruit the infants, and they will also be responsible for sending the envelopes to the nutritional unit.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 2, 2023
• Study Start: February 20, 2023
• Primary Completion: June 10, 2023
• Study Completion: September 10, 2023
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)