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NCT03889197 · ClinicalTrials.gov registry record · Phase 4
Physiologic Approach to Sodium Supplementation in Premature Infants
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
NCT03889197: Completed Phase 4 study, sponsored by Indiana University.
NCT03889197 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 90 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03889197, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
Study Summary
Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, \<1500 grams at birth) infants as assessed by discharge weight. This study will evaluate if a sodium supplementation algorithm guided by spot urine sodium measurements can improve postnatal growth.
Primary Outcome
Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.
Interventions
- DRUG Sodium supplementation guided by urine sodium concentration algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 4 |
What the finished NCT03889197 record still lists
NCT03889197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium supplementation guided by urine sodium concentration algorithm is the first listed.
NCT03889197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03889197 about?
NCT03889197 is a clinical study titled "Physiologic Approach to Sodium Supplementation in Premature Infants". Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, \<1500 grams at birth) infants as assessed by discharge weight. This study will evaluate if a sodium supplementation algorithm guided by spot urine sodium measurements can improve postnatal growth.
What is the current status of trial NCT03889197?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2019-07-01. Estimated completion is 2023-08-15.
What interventions are being tested in trial NCT03889197?
The interventions under investigation include: Sodium supplementation guided by urine sodium concentration algorithm (DRUG).
Who is sponsoring clinical trial NCT03889197?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03889197's enrollment target sits among peer trials
90 886th of 2000 higher than 1,088 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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