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NCT04977817 · ClinicalTrials.gov registry record
Probiotics/TPN in the NICU
A clinical trial of Necrotizing Enterocolitis of Newborn and Total Parenteral Nutrition, sponsored by Pediatrix.
- Completed
- Registry status
- 150
- Enrollment target
- 2
- Study locations
NCT04977817: Completed study of Necrotizing Enterocolitis of Newborn and Total Parenteral Nutrition, sponsored by Pediatrix.
NCT04977817 is a study of Necrotizing Enterocolitis of Newborn and Total Parenteral Nutrition that has completed, run by Pediatrix. The registered enrollment target is 150 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04977817, a study of Necrotizing Enterocolitis of Newborn and Total Parenteral Nutrition, has completed, sponsored by Pediatrix.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants \< 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at Desert Neonatal Intensive Care Units (NICU). The primary endpoint of capturing the number of days of TPN administration can reflect that an infant is progressing towards readiness for the initiation or advancement of enteral feedings at an earlier interval. The relationship between probiotic administration and the incidence of NEC, culture positive sepsis, and mortality is of interest to us and will be captured. Finally, the assessment of the tolerance of probiotic administration and the potential positive impact on growth and development in these premature infants may validate our current practices.
Primary Outcome
Evaluate the effects of a probiotic dietary supplement (Similac Probiotic Tri-Blend) on number of days on total parenteral nutrition (TPN) in infants admitted to the Neonatal Intensive Care Unit (NICU).
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Similac Probiotic Tri-Blend
Study Locations (2)
Arizona
- Banner Children's at Desert - Mesa
- Banner University Medical Center Phoenix - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2022-08-26 |
What the finished NCT04977817 record still lists
NCT04977817 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Necrotizing Enterocolitis of Newborn appearing as the primary indexed condition, and to 1 intervention - of which Similac Probiotic Tri-Blend is the first listed.
NCT04977817 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT04977817 about?
NCT04977817 is a clinical study titled "Probiotics/TPN in the NICU". The purpose of this study is to evaluate the effect of probiotic administration on TPN dependence in infants \< 32 weeks GA and BW 1500 grams or less in the Banner - University Medical Center Phoenix and Banner Children's at Desert Neonatal Intensive Care Units (NICU). The primary endpoint of captur...
What is the current status of trial NCT04977817?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2021-11-03. Estimated completion is 2022-08-26.
What conditions does trial NCT04977817 study?
This clinical trial studies the following conditions: Necrotizing Enterocolitis of Newborn, Total Parenteral Nutrition.
What interventions are being tested in trial NCT04977817?
The interventions under investigation include: Similac Probiotic Tri-Blend (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04977817?
This trial is sponsored by Pediatrix, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04977817 being conducted?
This trial has 2 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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