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NCT01795638 · ClinicalTrials.gov registry record · Phase 4
Sodium Supplementation and Growth in Very Low Birth Weight Infants
A Phase 4 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT01795638: Clinical Trial Phase 4 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01795638 is a Phase 4 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01795638, a Phase 4 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several reports have indicated a positive sodium balance is critical in ensuring good weight gain in very low birth weight infants, however these infants are susceptible to low serum sodium concentrations. Urine sodium values are sometimes used to diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but there is no evidence for this practice in preterm neonates. Our central hypothesis is that early supplementation with sodium will ensure positive sodium balance in very low birth weight infants and will result in optimal weight gain and enhanced long term outcomes. Secondarily we hypothesize that low sodium concentrations in the urine will not correlate with low serum sodium values.
Primary Outcome
Average weight gain in g/kg/day and also as a % birthweight over the first six weeks of the study will be compared between the two study arms
Interventions
- DRUG Placebo
- DRUG Sodium chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
Why NCT01795638 stopped before completion
NCT01795638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01795638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01795638 about?
NCT01795638 is a clinical study titled "Sodium Supplementation and Growth in Very Low Birth Weight Infants". Adequate growth during the neonatal period is critical for optimal long term outcomes. Despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. Several...
What is the current status of trial NCT01795638?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2009-10. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01795638?
The interventions under investigation include: Placebo (DRUG), Sodium chloride (DRUG).
Who is sponsoring clinical trial NCT01795638?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01795638's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 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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