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Indomethacin PK-PD in Extremely Preterm Neonates

NCT04025177 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-10-06

No results posted yet for this study

Summary

This is a phase II open-label study evaluating the pharmacokinetics and pharmacodynamics of targeted early use of indomethacin for PDA treatment in preterm neonates \<27 weeks' gestational age.

Conditions

  • Patent Ductus Arteriosus After Premature Birth

Interventions

DRUG

Indomethacin Injection

The dose of indomethacin will be 0.1 mg/kg/dose, based on birth weight, intravenously every 24 hours for a total of 3 doses. Doses 2 and 3 may be administered between 23.5 and 24.5 hours after the previous dose. Doses will be rounded to two significant figures.

Sponsors & Collaborators

  • St. Boniface Hospital

    collaborator OTHER

  • Health Sciences Centre, Winnipeg, Manitoba

    collaborator OTHER

  • University at Buffalo

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Deepak Louis, MD · University of Manitoba

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-08-31
Completion
2022-02-28
FDA Drug
Yes

Countries

  • Canada

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 NCT04025177 on ClinicalTrials.gov