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COMPLETED Phase 2

Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age

NCT01508455 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks through \< 36 weeks gestational age.

Conditions Studied

Interventions

  • DRUG Midazolam
  • DRUG Dexmedetomidine
  • DRUG Morphine
  • DRUG Fentanyl

Study Locations (4)

Kentucky

  • — Louisville

Pennsylvania

  • — Pittsburgh

South Carolina

  • — Greenville

West Virginia

  • — Morgantown

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2012-03
Est. Completion 2012-05
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01508455

The ClinicalTrials.gov registry entry for NCT01508455 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospira, now a wholly owned subsidiary of Pfizer, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Anesthesia appearing as the primary indexed condition, and to 4 interventions — of which Midazolam is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01508455 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Kentucky, Pennsylvania, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01508455 about?

NCT01508455 is a clinical study titled "Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age". The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks through \< 36 weeks gestational age.

What is the current status of trial NCT01508455?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2012-03. Estimated completion is 2012-05.

What conditions does trial NCT01508455 study?

This clinical trial studies the following conditions: Anesthesia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01508455?

The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG), Morphine (DRUG), Fentanyl (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01508455?

This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01508455 being conducted?

This trial has 4 study locations across Kentucky, Pennsylvania, South Carolina, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial