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A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants

Primary Purpose

Feeding; Difficult, Newborn, Necrotizing Enterocolitis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multi-strain Probiotic
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Feeding; Difficult, Newborn

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants with a birth weight < 1500g
  • admission to NICU at The Nebraska Medical Center

Exclusion Criteria:

  • infants who have congenital anomalies
  • have a diagnosis of a congenital metabolic disease
  • are made a ward of the State or
  • are born to a mother < 19 years of age

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Multi-strain Synbiotic

    Multi-strain Probiotic

    Arm Description

    Multi-strain probiotic with prebiotics

    Multi-strain Probiotic without prebiotics.

    Outcomes

    Primary Outcome Measures

    Comparing a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts
    Infants will be given the synbiotic or probiotic supplementation within the first week of life (upon inititation of enteral feedings) until approximately 34 weeks corrected gestational age.

    Secondary Outcome Measures

    Compare the difference between two groups (multi-strain synbiotic vs. multi-strain probiotic) on demographic data and selected standard clinical infant outcomes.
    Two probiotic groups will be compared on demographics: mean [birth wt(g), birth length(cm), birth hc(cm), GA at birth, 1-& 5- minute APGAR scores], race, gender, prenatal antibiotics(y/n), and enteral feeding type(breastmilk, formula, both); and on selected infant outcomes: Feeding Intolernce(number of times the feeding care plan is disrupted), NEC(y/n), late-onset sepsis(y/n), IVH(y/n;Grade I-IV), PDA(y/n), CLD(y/n), mean [endotracheal ventilation(days), inspired oxygen, discharge wt(g),discharge length(cm), discharge hc(cm), days to reach full feedings, length of stay, days on antibiotics].
    Compare the difference between infants successfully colonized with probiotic organisms (>10^2 colonies on a 10^4-fold dilution plate)to infants not successfully colonized on demographics and selected standard clinical outcomes
    Two colonization groups will be compared on demographics: mean[birth wt(g), birth length(cm),birth hc(cm),GA at birth,1-& 5- minute APGAR scores],race, gender,prenatal antibiotics(y/n),and enteral feeding type(breastmilk, formula, both); and on selected infant outcomes: Feeding Intolernce(number of times the feeding care plan is disrupted), NEC(y/n), late-onset sepsis(y/n), IVH(y/n;Grade I-IV), PDA(y/n), CLD(y/n), mean [endotracheal ventilation(days), inspired oxygen, discharge wt(g),discharge length(cm), discharge hc(cm), days to reach full feedings, length of stay, days on antibiotics].
    Compare infants successfully colonized with probiotic organisms(>10^2 colonies on a 10^4-fold dilution plate) to infants not successfully colonized on stress biomarker levels
    Interquartile ranges of biomarkers will be compared between the two colonization groups. Biomarkers include: serum cortisol(cord blood), salivary cortisol (DOL 1,7), serum 8-hydroxydeoxyguanosine (cord blood), urinary 8-hydroxydeoxyguanosine (DOL 1,7)
    Compare trends of stress biomarker levels in relation to demographics and selected standard infant outcomes
    Interquartile ranges of biomarkers (listed above) will be compared on the demographic data and selected standard infant outcomes (listed above) at each time (DOL 1, 7) and over-time.
    Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes.
    Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.

    Full Information

    First Posted
    March 16, 2011
    Last Updated
    August 10, 2023
    Sponsor
    University of Nebraska
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01337921
    Brief Title
    A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
    Official Title
    A Randomized Controlled Trial on a Multi-strain Synbiotic vs. a Multi-strain Probiotic on Fecal Colonization in the Very Low Birth Weight Infant
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Pending further safety information regarding polysaccharides and premature infants
    Study Start Date
    June 2011 (Anticipated)
    Primary Completion Date
    June 16, 2011 (Actual)
    Study Completion Date
    June 16, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34 weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1, DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24 months CGA.
    Detailed Description
    Feeding Intolerance and other GI issues are a major concern in a NICU hospitalized population. Successful colonization with probiotic bacteria is thought to impact the incidence of GI related issues. This study will study the impact of prebiotics on the colonization of a population of VLBW infants in the NICU setting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Feeding; Difficult, Newborn, Necrotizing Enterocolitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Multi-strain Synbiotic
    Arm Type
    Experimental
    Arm Description
    Multi-strain probiotic with prebiotics
    Arm Title
    Multi-strain Probiotic
    Arm Type
    Active Comparator
    Arm Description
    Multi-strain Probiotic without prebiotics.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Multi-strain Probiotic
    Other Intervention Name(s)
    Lactobacillus
    Intervention Description
    Multi-strain Synbiotic: 1.5 billion CFU of Lactobacillus acidophilus, Bifidobacterium bifidum,and Bifidobacterium lactis WITH galacto-oligosaccharide(GOS)/fructo-oligosaccharide (FOS) combination at 1g/dL (0.9g/dL GOS/ 0.1g/dL FOS)
    Primary Outcome Measure Information:
    Title
    Comparing a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts
    Description
    Infants will be given the synbiotic or probiotic supplementation within the first week of life (upon inititation of enteral feedings) until approximately 34 weeks corrected gestational age.
    Time Frame
    1,2, 3, 4 and 34 weeks of age
    Secondary Outcome Measure Information:
    Title
    Compare the difference between two groups (multi-strain synbiotic vs. multi-strain probiotic) on demographic data and selected standard clinical infant outcomes.
    Description
    Two probiotic groups will be compared on demographics: mean [birth wt(g), birth length(cm), birth hc(cm), GA at birth, 1-& 5- minute APGAR scores], race, gender, prenatal antibiotics(y/n), and enteral feeding type(breastmilk, formula, both); and on selected infant outcomes: Feeding Intolernce(number of times the feeding care plan is disrupted), NEC(y/n), late-onset sepsis(y/n), IVH(y/n;Grade I-IV), PDA(y/n), CLD(y/n), mean [endotracheal ventilation(days), inspired oxygen, discharge wt(g),discharge length(cm), discharge hc(cm), days to reach full feedings, length of stay, days on antibiotics].
    Time Frame
    From birth to NICU discharge (average 36 weeks corrected gestational age)
    Title
    Compare the difference between infants successfully colonized with probiotic organisms (>10^2 colonies on a 10^4-fold dilution plate)to infants not successfully colonized on demographics and selected standard clinical outcomes
    Description
    Two colonization groups will be compared on demographics: mean[birth wt(g), birth length(cm),birth hc(cm),GA at birth,1-& 5- minute APGAR scores],race, gender,prenatal antibiotics(y/n),and enteral feeding type(breastmilk, formula, both); and on selected infant outcomes: Feeding Intolernce(number of times the feeding care plan is disrupted), NEC(y/n), late-onset sepsis(y/n), IVH(y/n;Grade I-IV), PDA(y/n), CLD(y/n), mean [endotracheal ventilation(days), inspired oxygen, discharge wt(g),discharge length(cm), discharge hc(cm), days to reach full feedings, length of stay, days on antibiotics].
    Time Frame
    1 week of life to NICU discharge
    Title
    Compare infants successfully colonized with probiotic organisms(>10^2 colonies on a 10^4-fold dilution plate) to infants not successfully colonized on stress biomarker levels
    Description
    Interquartile ranges of biomarkers will be compared between the two colonization groups. Biomarkers include: serum cortisol(cord blood), salivary cortisol (DOL 1,7), serum 8-hydroxydeoxyguanosine (cord blood), urinary 8-hydroxydeoxyguanosine (DOL 1,7)
    Time Frame
    day of life 1 to day of life 7
    Title
    Compare trends of stress biomarker levels in relation to demographics and selected standard infant outcomes
    Description
    Interquartile ranges of biomarkers (listed above) will be compared on the demographic data and selected standard infant outcomes (listed above) at each time (DOL 1, 7) and over-time.
    Time Frame
    day of life 1 to day of life 7
    Title
    Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes.
    Description
    Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.
    Time Frame
    6, 16 & 24 months corrected gestational age.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infants with a birth weight < 1500g admission to NICU at The Nebraska Medical Center Exclusion Criteria: infants who have congenital anomalies have a diagnosis of a congenital metabolic disease are made a ward of the State or are born to a mother < 19 years of age
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ann Anderson-Berry, MD
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Corrine K Hanson, PhD
    Organizational Affiliation
    UNMC
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants

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