Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
249 participants
INTERVENTIONAL
2023-05-15
2025-10-15
Brief Summary
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It aims to answer:
Does probiotics improve the health and growth outcomes in preterm neonates in our population? Does single vs multiple strain of probiotics have difference in effects?
Participants will:
Participants given either single strain or multiple strain probiotics for 28 days post birth.
Data about mortality, morbidity, feeding pattern and growth (weight, height, head circumference gain) recorded on daily basis.
Detailed Description
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Primary objective: The primary objective of our trial will be to compare the incidence and severity of Necrotizing enterocolitis (NEC) from the time of trial participation till the end of trial treatment (28 days) according to Bell's grading criteria.
Secondary objectives:
All these outcomes will be measured from the day intervention started to the end of supplementation (28 days)
* To evaluate incidence of sepsis, intracerebral haemorrhage and periventricular leukomalacia, retinopathy of prematurity and bronchopulmonary dysplasia)
* To estimate the time to full enteral feeding (i.e., ≥150 ml/kg/day) and feeding tolerance based on Davy's Neonatal Feeding Assessment Scale (NFAS).
* To determine the effect of probiotics on growth (weight, height, and head circumference) of premature babies
* To assess comparative efficacy of single strain vs combination probiotics for aforementioned objectives
Framework/hypothesis: The experimental group P2 (Lactobacillus rhamnosus GG) and Group P3- ( Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4) are superior to control group (Placebo) as preventing NEC and other morbidities in preterm neonates, thus improving feeding tolerance and overall growth.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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P1
1 ml of 10% dextrose water will be dispensed in 5cc syringe and administered orally or via feeding tube for 28 days.
Dextrose 10%
P1
P2
Single strain probiotic- Lactobacillus rhamnosus GG. The single dose 1.5×109 CFU/day as 1 mL of the reconstituted solution will be given every day via the feeding tube or orally as applicable until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×109 CFU/day once feeds exceed 50mL/kg/day.
Lactobacillus Rhamnosus GG
Single Strain
P3
Multiple strain probiotic-Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4.
The single dose 1.5×109 CFU/day as 1 mL of the reconstituted solution will be given every day via the feeding tube or orally as applicable until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×109 CFU/day once feeds exceed 50mL/kg/day.
Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4
Multiple Strain
Interventions
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Dextrose 10%
P1
Lactobacillus Rhamnosus GG
Single Strain
Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4
Multiple Strain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
36 Weeks
ALL
No
Sponsors
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Madiha, MPhil
OTHER
Responsible Party
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Madiha, MPhil
Co-investigator
Principal Investigators
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Imran Masood, PhD
Role: PRINCIPAL_INVESTIGATOR
The Islamia University of Bahawalpur, Khawaja Fareed Campus
Locations
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Bahawal Victoria Hospital
Bahawalpur, Punjab Province, Pakistan
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NEOPRO-SvsM
Identifier Type: -
Identifier Source: org_study_id