A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
- Conditions
- Feeding; Difficult, NewbornNecrotizing Enterocolitis
- Interventions
- Dietary Supplement: Multi-strain Probiotic
- Registration Number
- NCT01337921
- Lead Sponsor
- University of Nebraska
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- infants with a birth weight < 1500g
- admission to NICU at The Nebraska Medical Center
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multi-strain Synbiotic Multi-strain Probiotic Multi-strain probiotic with prebiotics Multi-strain Probiotic Multi-strain Probiotic Multi-strain Probiotic without prebiotics.
- Primary Outcome Measures
Name Time Method Comparing a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts 1,2, 3, 4 and 34 weeks of age 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
Name Time Method Compare the difference between two groups (multi-strain synbiotic vs. multi-strain probiotic) on demographic data and selected standard clinical infant outcomes. From birth to NICU discharge (average 36 weeks corrected gestational age) 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 1 week of life to NICU discharge 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 day of life 1 to day of life 7 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 day of life 1 to day of life 7 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. 6, 16 & 24 months corrected gestational age. Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.