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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 is a Phase 2 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 144 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01783041
The ClinicalTrials.gov registry entry for NCT01783041 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 5% Dextrose is the first listed.
NCT01783041 reports 0 study locations.
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.
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