Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Growth, Feeding Intolerance
Conditions
Keywords
Probiotics, Preterm neonates, Single vs Multiple strain
Brief summary
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.
Detailed description
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) * 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.
Interventions
DIETARY_SUPPLEMENTDextrose 10%
P1
Single Strain
DRUGBifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4
Multiple Strain
Sponsors
Madiha, MPhil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Placebo-controlled randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Weeks
Healthy volunteers
No
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
* Neonates with major congenital malformations, gastrointestinal anomalies, early onset sepsis (C-reactive protein (CRP) \>10 mg/L in the first 72 h of life) and renal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Necrotizing enterocolitis (NEC) | From the day intervention started to day 28 of supplementation | Bell's classification used for grading and diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Sepsis | From the day intervention started to day 28 of supplementation | 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. |
| Feeding Intolerance | From the day intervention started to day 28 of supplementation | 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. |
| Weight | From the day intervention started to day 28 of supplementation | Weight measured in grams |
| Body length | From the day intervention started to day 28 of supplementation | Measured in millimeters daily once |
| Head Circumference | From the day study started to day 28 of supplementation | Measured in millimeters |
Countries
Pakistan
Outcome results
None listed