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    Pro Biotics

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    Emmanuel Handsome

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    © All Rights Reserved
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    Pro Biotics

    Uploaded by

    Emmanuel Handsome
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    © © All Rights Reserved

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    19 views37 pages

    Pro Biotics

    Uploaded by

    Emmanuel Handsome

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 37

    FEDERAL MEDICAL CENTRE YENAGOA

    DEPARTMENT OF PAEDIATRICS

    JOURNAL ARTICLE REVIEW

    DR ANI MARYJANE CHIZOBA


    JUNE 26, 2024
    Probiotics and growth in preterm infants:
    A randomized controlled trial.
    AUTHORS
    • Stephane Hays,
    • Aurelien Jacquot ,
    • Hel ene Gauthier,
    • Christian Kempfe ,
    • Anne Beissel ,
    • Odile Pidoux
    et al.
    OUTLINE
     Introduction
     Aim
     Methodology
     Results
     Discussion
     Conclusion
     Critique
    INTRODUCTION
     Optimal postnatal growth for VLBW infants is crucial.
     Aggressive nutritional support and probiotics including
    including Bifidobacterium, significantly reduce the
    incidence of NEC, and mortality
     This potentially influences long-term obesity risks via
    gut microflora.
    INTRODUCTION
     Observational studies link gut microbiota diversity
    to weight gain in VLBW infants.
     While Bifidobacterium breve may improve weight,
    randomized trials with other probiotics showed no
    significant weight gain improvement.
    OBJECTIVES
     To evaluate the effect of Bifidobacterium
    supplementation on short-term postnatal growth and
    body composition in VLBW infants

     To assess the safety of probiotic administration


    MATERIALS AND METHODS
     A multicenter, double-blind, randomized, placebo controlled trial
    comparing two groups of patients treated with probiotics or a
    placebo

     INCLUSION CRITERIA
     Hospitalized Preterm infants
     Gestational age at birth of between 25 weeks and 31 weeks with
    birth weight of between 700 g and 1600 g appropriate for GA
     Admission to a participating unit within seven days of life
     Enteral feeding initiated before the fifth day of life
    MATERIALS AND METHODS
    EXCLUSION CRITERIA
     NEC stage 1B
     Severe malformations or medical/surgical
    conditions
     No antenatal steroids for mothers
     Parents too far for follow-up visits
     Interruption of feeding for over 72 hours due to
    severe GI disorders, surgery, or cow's milk
    intolerance
     Parental consent withdrawal
    MATERIALS AND METHODS
     INTERVENTION
     Preterm infants received daily blinded capsules
    of probiotics or maltodextrin alone.
     Probiotics varied by group, dissolved in water,
    administered by nurses, starting within the first
    week, for 4-6 weeks.
    MATERIALS AND METHODS
    SAMPLE SIZE AND SAMPLING
     The sample size aimed to detect a 150g weight
    difference with 90% power, 5% alpha, and 1:3
    randomization.
     Assuming 10% dropout: 50 in group C, 150 in group P,
    stratified by center and gestational age.
     There were two main groups: control (C) and
    probiotics (P, divided into P1, P2, P3).
     Randomization within each center and stratum was
    1:1:1:1, yielding a 1:3 ratio overall, using consecutively
    numbered, sealed envelopes
    MATERIALS AND METHODS
    Feeding was standardized: parenteral feeding
    until 100-120 mL/kg/day enteral intake.
    Infants received pasteurized human milk or
    preterm formula, enriched as needed, until
    1500 g or 41 weeks corrected gestational age.
    MATERIALS AND METHODS
    Assessment:
    Visits were on day 1, day 21, day 28 or 42, and
    study's end. Primary measure: body weight.
    Growth evaluated by weight gain (g/kg/day),
    weekly length, and head circumference
    increases.
    MATERIALS AND METHODS
     Z-scores for growth metrics were calculated
    using Olsen's curves.
     At 41 weeks, DEXA scans assessed bone
    mineral content and soft tissue.
     Quality control involved regular use of a DEXA
    phantom across three units.
    MATERIALS AND METHODS
     Daily enteral and parenteral intakes recorded
    total energy and protein intake.
     NEC at Bell's stage 2 and a gastrointestinal
    tolerance score, based on regurgitations,
    vomiting, stools, and abdominal distension,
    were also recorded.
    MATERIALS AND METHODS
     On day 21, gut microbiota diversity was analyzed
    using PCR temporal temperature gradient gel
    electrophoresis
     Fecal calprotectin was measured via an enzyme-
    linked immunosorbent assay
    MATERIALS AND METHODS
     Blood cultures were taken when late-onset sepsis
    was suspected.
     Medical staff were blinded to intervention
    groups.
     Parental and antenatal data were extracted from
    medical records.
     Daily body weights were recorded, and growth
    metrics were logged electronically until
    discharge.
    MATERIALS AND METHODS
     DATA ANALYSIS
     Three populations were analyzed: intention-
    to-treat (ITT), per protocol (PP), and safety.
     ITT included all who received at least one
    placebo or probiotic dose and were assessed
    during treatment.
     PP excluded major protocol deviations.
    Safety included all who received at least one
    dose and had safety data collected.
    MATERIALS AND METHODS
    • A blinded statistician analyzed data using SAS 9.2
    with two-sided tests at 5% significance and
    Bonferroni corrections if needed.
    • Anthropometric measurements were analyzed
    with ANCOVAs, adjusting for baseline values,
    daily intakes, and gender.
    • Randomization strata and treatment groups
    were considered.
    ETHICAL CONSIDERATION
     The study was conducted in accordance with
    French regulations and the Helsinki
    Declaration of 1975 that was revised in 1983.
     The protocol was approved by the lead
    center's ethics committee and by the French
    National Agency for Medicines and Health
    Products Safety.
    RESULT
    RESULT

     Between November 2007 and June 2010, 199


    infants, aged 6.4 ± 1.5 days on average, were
    enrolled.
     Forty (20.3%) subjects withdrew prematurely;
    11 (21.2%) from group C and 29 (20%) from
    group P.
     The mean hospital stay was 50.4 ± 17.4 days,
    consistent across both groups.
    RESULT
    RESULT
     During supplementation, groups C and P had
    similar growth outcomes with no significant
    differences in weight or daily gain.
     Bifidobacterium spp. were more prevalent in
    group P, especially with B. lactis alone or with B.
    longum.
    RESULT
     Mean diversity scores were similar between
    group C (3.4 ± 1.8) and group P (3.4 ± 1.3) (p =
    0.75).
     Diversity index did not significantly affect daily
    weight gain from inclusion to day 21, adjusted
    for covariates.
     Fecal calprotectin levels were comparable
    across treatment groups.
    RESULT
    RESULT
    RESULT
     The incidence of bloodstream infections and types of microorganisms isolated were
    similar between groups P and C (p = 0.912).
     Adverse events occurred in 19.2% of group C and 24.0% of group P, with serious adverse
    events in 7.5% of group C and 1.4% of group P, none related to the treatment.
     Deaths during the supplementation period were 1.9% in group C and 2.7% in group P,
    with one additional death in group P after the period.
    RESULT
    DISCUSSION
     Probiotic supplementation in high-risk preterm infants did not
    enhance weight gain or gastrointestinal tolerance versus
    placebo. Prior research indicated potential benefits in enteral
    feeding, but this was not observed.
    DISCUSSION
     In this first double-blind study on weight gain,
    no significant differences were found in
    postnatal weight gain or gut microbiota
    between probiotic and control groups, possibly
    due to strain specificity or neonatal care
    practices
    DISCUSSION
     The study evaluated probiotic impact on
    preterm infants' growth and gut microbiota,
    noting modest microbiota effects but no
    growth improvement.
     Comparisons used pooled probiotics versus
    placebo, acknowledging energy and protein
    intake differences.
    DISCUSSION
     In our study, fecal calprotectin did not increase
    in infants receiving a two-probiotic mixture,
    suggesting NEC incidence might be random.
     Careful evaluation of probiotic strategies,
    including strains and doses, is crucial before
    routine use in preterm infants.
    CONCLUSION
     Probiotics showed no significant impact on gastrointestinal
    tolerance or short-term growth.
     Both tested probiotics and their mixture lacked clear benefits.
     No probiotic-related sepsis occurred.
     Future research could explore optimal strains, symbiotic
    organisms, and dosages for NEC prevention and growth
    promotion.
    CRITIQUE
    Why the study?- To assess the magnitude and predictors of
    neonatal asphyxia among newborns at public hospitals.

    Authors - Are Paediatricians, Nurses and Statistician

    Title - Appropriate

    Aims - Well stated and met

    Methodology-
    • Inclusion and exclusion criteria clearly stated,
    • Sample size calculation and study design stated
    • Data analysis was done using appropriate statistical tests
    CRITIQUE
    Result- Results well presented in tables and pie chart

    Discussion- Well done

    Limitation- Well stated

    Reproducibility- The methodology can be reproduced in any


    public hospital including our facility.

    Recommendations- Well stated

    Clinical relevance - The study is relevant in our clinical practice.

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