Patent Ductus Arteriosus After Premature BirthPhase 2INDONCT04025177
Indomethacin PK-PD in Extremely Preterm Neonates
A Phase 2 study testing Indomethacin Injection in people with Patent Ductus Arteriosus After Premature Birth, run by University of Manitoba at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 26 weeks
- Conditions the study is for
- Patent Ductus Arteriosus After Premature Birth
- What is being tested?
- Indomethacin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2020to Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 26 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Boniface General Hospital Research Centre
Winnipeg, Manitoba, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Indomethacin Used for PDA Treatment in Extremely Preterm Neonates <27 Weeks Gestational Age
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.
Read the detailed description
Neonates will be enrolled following an echocardiogram performed within 12 hours after birth that confirms an open PDA (with no other contraindications for indomethacin treatment). After enrollment, neonates will receive intravenous indomethacin at a dose of 0.1mg/kg every 24 hours for 3 days. Indomethacin levels will be measured at regular intervals. Urine output and serum electrolytes will be monitored prior to each dose of indomethacin. An echocardiogram will be repeated after completion of indomethacin treatment (between 72-120 hours of age) to reassess the status of PDA.
- Being tested
- Indomethacin Injection
- Keywords
- Indomethacin, Pharmacokinetics, Preterm birth, Pharmacodynamics
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Indomethacin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 48 hour following the last dose
Secondary outcomes (4)
Percentage of Participants with Patent Ductus Arteriosus Closure
Confirmed by echocardiogram
Measured: Within 48 hrs after the last dose
Percentage of Participants with Intraventricular hemorrhage
Confirmed by cranial ultrasound performed and graded using Papile's classification system
Measured: Within the first 7 days of life.
Duration of mechanical ventilation of each patient
Number of days the infant was intubated and ventilated.
Measured: trough hospital discharge, an average of up to 36 weeks gestational age
Percentage of Participants with Adverse Events
development of any type A adverse reactions in the infants receiving indomethacin therapy
Measured: trough hospital discharge, an average of up to 36 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study startJan 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: Halted due to feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus Arteriosus After Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- St. Boniface Hospital, Health Sciences Centre, Winnipeg, Manitoba, University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Deepak Louis, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025177
- Sponsor's protocol ID
- B2018:095
- Acronym
- INDO
- Status last verified
- Mar 2020
- First submitted
- 27 May 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Indomethacin Used for PDA Treatment in Extremely Preterm Neonates <27 Weeks Gestational Age
- ClinicalTrials.gov ID
- NCT04025177
- Acronym / sponsor ID
- INDO / B2018:095
- Keywords
- Indomethacin, Pharmacokinetics, Preterm birth, Pharmacodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Halted due to feasibility issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- St. Boniface Hospital, Health Sciences Centre, Winnipeg, Manitoba, University at Buffalo
- Study start
- Jan 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neonates will be enrolled following an echocardiogram performed within 12 hours after birth that confirms an open PDA (with no other contraindications for indomethacin treatment). After enrollment, neonates will receive intravenous indomethacin at a dose of 0.1mg/kg every 24 hours for 3 days. Indomethacin levels will be measured at regular intervals. Urine output and serum electrolytes will be monitored prior to each dose of indomethacin. An echocardiogram will be repeated after completion of indomethacin treatment (between 72-120 hours of age) to reassess the status of PDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with an open PDA | Experimental | Drug: Indomethacin InjectionNeonates 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. |
Who may qualify
- Ages
- 23 to 26 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin InjectionThe 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. | Drug | Neonates with an open PDA |
Primary outcome
Area under the curve from serial Indomethacin levels
Time frame: At 48 hour following the last dose
Blood samples will be drawn from patients to determine the serum indomethacin levels to determine the area under the curve
4 secondary outcomes
Percentage of Participants with Patent Ductus Arteriosus Closure
Time frame: Within 48 hrs after the last dose
Percentage of Participants with Intraventricular hemorrhage
Time frame: Within the first 7 days of life.
Duration of mechanical ventilation of each patient
Time frame: trough hospital discharge, an average of up to 36 weeks gestational age
Percentage of Participants with Adverse Events
Time frame: trough hospital discharge, an average of up to 36 weeks gestational age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No
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Management of the PDA Trial
Infant, Premature, Patent Ductus Arteriosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Louis, MD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indomethacin Injection in people with Patent Ductus Arteriosus After Premature Birth, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve from serial Indomethacin levels (time frame: At 48 hour following the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.