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Population PK/PD of Off Label Drugs in Premature Neonates

NCT02421068 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 246

Last updated 2024-04-03

No results posted yet for this study

Summary

This study will provide information on the pharmacokinetics, safety and effectiveness of off--label drugs used in critically ill premature infants: doxapram, fentanyl, midazolam, paracetamol, phenobarbital, sildenafil, levetiracetam, ibuprofen and fluconazole. PK/PD analysis with NONMEM (non-linear mixed effects modelling) will result in (adapted) dosage guidelines, thus contributing towards an improvement in the quality of care and cost efficiency. Furthermore the development of Dried Blood Spot (DBS) analysis is investigated for these drugs as a minimally invasive method for conventional patient care and to perform pharmacological studies in children. The adapted dosage guidelines will be implemented directly into clinical practice in collaboration with the NKFK. Therefore the study is designed as an observational multicenter study to be able to collect sufficient data for the drugs of interest.

Conditions

  • Premature Birth

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Leiden Amsterdam Centre for Drug Research (LACDR)

    collaborator UNKNOWN

  • Dutch Knowledge Centre for Pediatric Pharmacotherapy (NKFK)

    collaborator UNKNOWN

  • Centre for Human Drug Research, Netherlands

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Sinno H.P. Simons

    lead OTHER

Principal Investigators

  • Ronald de Groot, MD, PhD · Radboud University Medical Center

  • Dick Tibboel, MD, PhD · Erasmus Medical Center

  • David Burger, PharmD, PhD · Radboud University Medical Center

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Netherlands

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 NCT02421068 on ClinicalTrials.gov