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Pending further safety information regarding polysaccharides and premature infants
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-strain Synbiotic | Experimental | Multi-strain probiotic with prebiotics |
|
| Multi-strain Probiotic | Active Comparator | Multi-strain Probiotic without prebiotics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-strain Probiotic | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1,2, 3, 4 and 34 weeks of age |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Anderson-Berry, MD | University of Nebraska | Study Chair |
| Corrine K Hanson, PhD | UNMC | Study Chair |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| From birth to NICU discharge (average 36 weeks corrected gestational age) |
| 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]. | 1 week of life to NICU discharge |
| 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) | day of life 1 to day of life 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. | day of life 1 to day of life 7 |
| 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. | 6, 16 & 24 months corrected gestational age. |
| D007410 |
| Intestinal Diseases |