NCT04025177

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

October 6, 2021

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

May 27, 2019

Last Update Submit

September 28, 2021

Conditions

Patent Ductus Arteriosus After Premature Birth

Keywords

IndomethacinPharmacokineticsPreterm birthPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Area under the curve from serial Indomethacin levels

    Blood samples will be drawn from patients to determine the serum indomethacin levels to determine the area under the curve

    At 48 hour following the last dose

Secondary Outcomes (4)

  • Percentage of Participants with Patent Ductus Arteriosus Closure

    Within 48 hrs after the last dose

  • Percentage of Participants with Intraventricular hemorrhage

    Within the first 7 days of life.

  • Duration of mechanical ventilation of each patient

    trough hospital discharge, an average of up to 36 weeks gestational age

  • Percentage of Participants with Adverse Events

    trough hospital discharge, an average of up to 36 weeks gestational age

Study Arms (1)

Neonates with an open PDA

EXPERIMENTAL

Neonates born between 23 (0/7) and 26 (6/7) weeks gestational age with an open PDA, according to clinical protocol criteria, and no contraindication to the use of indomethacin.

Drug: Indomethacin Injection

Interventions

Indomethacin InjectionDRUG

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.

Neonates with an open PDA

Eligibility Criteria

Age23 Weeks - 26 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female infant born between 23 (0/7) and 26 (6/7) week GA
  • Infant diagnosed with PDA according to clinical protocol criteria
  • Able to adhere to indomethacin administration protocol
  • The patient is born in the study center.
  • Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
  • In the investigator's opinion, the subject's parent(s)/legal guardian(s) understand(s) and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.

You may not qualify if:

  • known major congenital malformations (renal, cardiac, gastrointestinal and central nervous system)
  • genetic syndromes-inborn errors of metabolism
  • severe renal compromise
  • intrauterine growth retardation with birth weight \<3rd centile
  • thrombocytopenia \<50,000/mm3
  • moderate to severe pulmonary hypertension
  • clinical sepsis -meningitis- hepatitis
  • anticipated drug-drug-interactions (specifically CYP2C9, CYP2C19 and UGT 1-1)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Boniface General Hospital Research Centre

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Deepak Louis, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

July 18, 2019

Study Start

January 1, 2020

Primary Completion

August 1, 2021

Study Completion

February 1, 2022

Last Updated

October 6, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)