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

University of Nebraska

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Feeding; Difficult, Newborn Necrotizing Enterocolitis

Interventions

Multi-strain ProbioticDIETARY_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)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1,2, 3, 4 and 34 weeks of age

Secondary Outcomes

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 \[endotracheal ventilation(days), inspired oxygen, discharge wt(g),discharge length(cm), discharge hc(cm), days to reach full feedings, length of stay, days on antibiotics\].

Time frame: 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 \[endotracheal ventilation(days), inspired oxygen, discharge wt(g),discharge length(cm), discharge hc(cm), days to reach full feedings, length of stay, days on antibiotics\].

Time frame: 1 week of life to NICU discharge

Data from ClinicalTrials.gov

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