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

This study has been withdrawn prior to enrollment.
(Pending further safety information regarding polysaccharides and premature infants)
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01337921
First received: March 16, 2011
Last updated: June 24, 2011
Last verified: June 2011

March 16, 2011
June 24, 2011
June 2011
June 2012   (final data collection date for primary outcome measure)
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 3 weeks of age ] [ Designated as safety issue: No ]
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 4 weeks of age ] [ Designated as safety issue: No ]
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 34 weeks corrected gestational age ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01337921 on ClinicalTrials.gov Archive Site
  • Compare the difference between two groups (multi-strain synbiotic vs. multi-strain probiotic) on demographic data and selected standard clinical infant outcomes. [ Time Frame: From birth to NICU discharge (average 36 weeks corrected gestational age) ] [ Designated as safety issue: No ]
    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 bewteen 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 [ Time Frame: 1 week of life to NICU discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: day of life 1 to day of life 7 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day of life 1 to day of life 7 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 months corrected gestational age. ] [ Designated as safety issue: Yes ]
    Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.
  • Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes. [ Time Frame: 16 months corrected gestational age ] [ Designated as safety issue: No ]
    Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.
  • Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes. [ Time Frame: 24 months corrected gestational age ] [ Designated as safety issue: Yes ]
    Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.
Same as current
Not Provided
Not Provided
 
A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
A Randomized Controlled Trial on a Multi-strain Synbiotic vs. a Multi-strain Probiotic on Fecal Colonization in the Very Low Birth Weight Infant

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Feeding; Difficult, Newborn
  • Necrotizing Enterocolitis
Dietary Supplement: Multi-strain Probiotic
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)
Other Name: Lactobacillus
  • Experimental: Multi-strain Synbiotic
    Multi-strain probiotic with prebiotics
    Intervention: Dietary Supplement: Multi-strain Probiotic
  • Active Comparator: Multi-strain Probiotic
    Multi-strain Probiotic without prebiotics.
    Intervention: Dietary Supplement: Multi-strain Probiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
June 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01337921
065-11-FB
No
Tiffany A Moore, RN, BSN, UNMC
University of Nebraska
Not Provided
Principal Investigator: Ann Anderson-Berry, MD UNMC, the Nebraska Medical Center
Principal Investigator: Corrine K Hanson, PhD UNMC
University of Nebraska
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP