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This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion.
The overall goal of this study is to test prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through one primary aim, a secondary aim, and exploratory aims, indicated below:
Primary aim: Compare weight, length, and head circumference Z-score growth between the study and placebo groups.
Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more) between the study and placebo groups.
Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.
Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of supplementation on reducing intestinal inflammation between the study and placebo groups.
Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to determine whether there is a shift in microbial composition towards bifidobacteria and other microbes that are capable of metabolizing prebiotic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Experimental Arm |
|
| Control | Placebo Comparator | Placebo Control Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic | Dietary Supplement | Prebiotic experimental group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Compare weight | Enrollment through study day 45 |
| Length | Compare length | Enrollment through study day 45 |
| Head Circumference | Compare head circumference | Enrollment through study day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Adaptation | Compare time to enteral autonomy | Enrollment through study day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Neurobehavior | Compare Neonatal intensive care unit Network Neurobehavioral Scale score | Enrollment through study day 45 |
| Gut inflammation | Compare gut inflammation by measurement of fecal calprotectin |
Inclusion Criteria:
Preterm infants who meet the following inclusion criteria will be eligible for randomization:
Exclusion Criteria:
Infants with the following conditions or situations at the time of randomization will be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital and affiliated NICUs | Columbus | Ohio | 43206 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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| Dextrose Control | Dietary Supplement | Dextrose Control |
|
| Enrollment through study day 45 |
| Fecal microbiome | Compare fecal microbiome | Enrollment through study day 45 |
| D000091642 | Urogenital Diseases |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |