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NCT03306316 · ClinicalTrials.gov registry record · NA
Prebiotic in Preterm Infants
A NA study, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT03306316 is a NA study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 44 participants.
The verdict
NCT03306316, a NA study, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
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.
Interventions
- DIETARY_SUPPLEMENT Prebiotic
- DIETARY_SUPPLEMENT Dextrose Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2018-07-04 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03306316
The ClinicalTrials.gov registry entry for NCT03306316 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prebiotic is the first listed.
NCT03306316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03306316 about?
NCT03306316 is a clinical study titled "Prebiotic in Preterm Infants". 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, anthropo...
What is the current status of trial NCT03306316?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2018-07-04. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT03306316?
The interventions under investigation include: Prebiotic (DIETARY_SUPPLEMENT), Dextrose Control (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03306316?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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