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NCT01783041 · ClinicalTrials.gov registry record · Phase 2
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
A Phase 2 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
NCT01783041: Completed Phase 2 study, sponsored by Montefiore Medical Center.
NCT01783041 is a Phase 2 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 144 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01783041, a Phase 2 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
Study Summary
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life. The micronutrient carnitine, which is present in breast milk and stored in the fetus late in pregnancy, has been shown to protect against brain injury in animal studies. Without supplementation, almost all preterm infants develop carnitine deficiency soon after birth. Thus it is important to determine if carnitine supplementation protects against brain injury and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will not develop carnitine deficiency and will have improved growth in the first two weeks of life and higher scores on developmental tests when compared to control infants who did not receive carnitine.
Primary Outcome
Time (in days) for infants in both arms of the study to regain birthweight - data presented as mean +/- SD.
Interventions
- DRUG 5% Dextrose
- DRUG L-carnitine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2013-01 |
| Est. Completion | 2021-12-28 |
| Phase | Phase 2 |
What the finished NCT01783041 record still lists
NCT01783041 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which 5% Dextrose is the first listed.
NCT01783041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01783041 about?
NCT01783041 is a clinical study titled "Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants". Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life. The micronutrient carnitine, which is present in breast milk and stored in the fetus late in pregnancy, has been shown to prote...
What is the current status of trial NCT01783041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2013-01. Estimated completion is 2021-12-28.
What interventions are being tested in trial NCT01783041?
The interventions under investigation include: 5% Dextrose (DRUG), L-carnitine (DRUG).
Who is sponsoring clinical trial NCT01783041?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01783041's enrollment target sits among peer trials
144 500th of 2000 higher than 1,494 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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