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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: Completed NA study, sponsored by Nationwide Children's Hospital.
NCT03306316 is a NA study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Compare weight
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 |
What the finished NCT03306316 record still lists
NCT03306316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Prebiotic is the first listed.
NCT03306316 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03306316's enrollment target sits among peer trials
44 1423rd of 2000 higher than 566 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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