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The goal of this randomized control clinical trial is to determine if probiotics can prevent mortality and morbidity in preterm neonates. It also evaluates effects of probiotics on feeding pattern and growth. It will also learn about the comparative effects of single vs multiple strain probiotics.
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.
This trial is single-centered, parallel, multi-arm, 1:1:1 randomized, blinded, placebo controlled clinical trial. It compares 3 groups; Group P1 (Placebo), Group P2-Single Strain probiotic (Lactobacillus rhamnosus GG) and Group P3- Multiple strains probiotic ( Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4) for preventing preterm neonatal morbidities, improving feeding tolerance and overall growth.
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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P1 | Placebo Comparator | 1 ml of 10% dextrose water will be dispensed in 5cc syringe and administered orally or via feeding tube for 28 days. |
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| P2 | Active Comparator | 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. |
|
| P3 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextrose 10% | Dietary Supplement | P1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing enterocolitis (NEC) | Bell's classification used for grading and diagnosis | From the day intervention started to day 28 of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Sepsis | Clinical sepsis is defined as condition with at least two signs of systemic inflammatory response (e.g. temperature >38 C or <36.5 C, tachycardia > 200/min etc.), one laboratory sign (e.g. C-reactive protein >20mg/L) but no proof of causative agent in blood culture. Clinical sepsis with proof of blood culture positive for causative agent was defined as confirmed sepsis. | From the day intervention started to day 28 of supplementation |
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Inclusion Criteria:
Preterm babies of gestational age <35+6days, birth weight <2500 grams, received and tolerated at-least one feed within 72 hours of birth and informed consent from parents or guardian.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imran Masood, PhD | The Islamia University of Bahawalpur, Khawaja Fareed Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahawal Victoria Hospital | Bahawalpur | Punjab Province | 62100 | Pakistan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 10, 2023 | Dec 8, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Placebo-controlled randomized clinical trial
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| Lactobacillus Rhamnosus GG |
| Drug |
Single Strain |
|
|
| Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4 | Drug | Multiple Strain |
|
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| Feeding Intolerance | A gastrointestinal tolerance score, based on gastric residual volume, emesis, abdominal distension, number of stools and nil per oral days was calculated to identify and score feeding intolerance. Each score as 1. A score of >2 was considered gastric intolerance. | From the day intervention started to day 28 of supplementation |
| Weight | Weight measured in grams | From the day intervention started to day 28 of supplementation |
| Body length | Measured in millimeters daily once | From the day intervention started to day 28 of supplementation |
| Head Circumference | Measured in millimeters | From the day study started to day 28 of supplementation |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |