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Safety of Fluconazole Treatment of Premature and Full-term Newborn Infants

NCT02079298 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-09-02

No results posted yet for this study

Summary

This study will investigate pharmacological interventions between fluconazole and ibuprofen when they are given to premature newborn babys. This in order to find out if the drugs are influencing each other when they are given at the same time. The study is meant to find out if there are reasons to adjust the dose when fluconazole and ibuprofen are given together.

Conditions

  • Ductus Arteriosis, Patent
  • Bacterial Infections and Mycoses

Interventions

DRUG

Treatment with fluconazole.

DRUG

2. Treatment with both fluconazole and Ibuprofen.

DRUG

3. Treatment with ibuprofen.

OTHER

4. No treatment with either fluconazole nor ibuprofen.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Anders Rane, MD, PhD, Senior professor

    lead OTHER

Principal Investigators

  • Anders Rane, Prof. MD · Karolinska Institutet

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02079298 on ClinicalTrials.gov