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NCT01125163 · ClinicalTrials.gov registry record · NA
Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT01125163: Completed NA study, sponsored by The University of Texas Health Science Center, Houston.
NCT01125163 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125163, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstrual age (or at discharge if sooner)?
Primary Outcome
For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA
Interventions
- DIETARY_SUPPLEMENT multivitamin
- DIETARY_SUPPLEMENT Iron Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-02 |
| Phase | NA |
What the finished NCT01125163 record still lists
NCT01125163 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which multivitamin is the first listed.
NCT01125163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01125163 about?
NCT01125163 is a clinical study titled "Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants". In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstru...
What is the current status of trial NCT01125163?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2010-05. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01125163?
The interventions under investigation include: multivitamin (DIETARY_SUPPLEMENT), Iron Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01125163?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01125163's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 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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