Patent Ductus ArteriosusCANRxPDANCT04347720
Canadian National PDA Treatment Study
An observational study of Patent Ductus Arteriosus and Extreme Prematurity, run by IWK Health Centre at 22 sites in Canada.
Trial summary
Patent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in preterm infants. Persistent PDA may result in higher rates of death, chronic lung disease (CLD), pulmonary hemorrhage, necrotizing enterocolitis (NEC), acute kidney injury (AKI), intraventricular hemorrhage (IVH) and cerebral… Read more about this study
- Who is it for?
- Ages Up to 12 weeks
- Conditions the study is for
- Patent Ductus Arteriosus, Extreme Prematurity
- What is being tested?
- Indomethacin, Ibuprofen and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,663 participants
- Where
- 22 sitesCanada
- Study dates
- 1 Jan 2020to 31 Dec 2023
- How long will I take part?
- 20 Weeks
- Phase
- Observational
- 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 Up to 12 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All infants born less than 29 weeks of gestation admitted to the participating sites will be included in the study. The population of interest will be those preterm infants <29 weeks gestational age (including outborns) with echocardiography confirmed PDA who will be treated according to attending team. Infants <29 weeks GA with echocardiography-confirmed PDA but never received treatment will be included as the control population. Infants <29 weeks GA who were never diagnosed with PDA will be included as the reference population
Who may be able to join
- Extremely preterm infants (<29 weeks gestational age) with an echocardiography confirmed PDA who will be treated according to attending team
Who cannot join
- Any infant who received pharmacotherapy for a clinically symptomatic PDA without prior echocardiographic confirmation of the presence of PDA will be excluded from all analyses.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Canada22 sites
Foothills Medical Centre
Calgary, Alberta
Royal Alexandra Hospital
Edmonton, Alberta
IWK Health Center
Halifax, Nova Scotia, B3K 6R8
Kingston Health Sciences Centre
Kingston, Ontario
London Health Sciences Centre
London, Ontario
The Moncton Hospital
Moncton, New Brunswick
CHU Sainte-Justine
Montreal, Quebec
Royal Columbian Hospital
New Westminster, British Columbia
Children's Hospital of Eastern Ontario
Ottawa, Ontario
Centre Hospitalier Universitaire de Quebec
Québec, Quebec
Regina General Hospital
Regina, Saskatchewan
Saint John Regional Hospital
Saint John, New Brunswick
Royal University Hospital
Saskatoon, Saskatchewan
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Hospital for Sick Children
Toronto, Ontario
Mount Sinai Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
British Columbia Women's Hospital
Vancouver, British Columbia
Victoria General Hospital
Victoria, British Columbia
Windsor Regional Hospital
Windsor, Ontario
Health Sciences Centre
Winnipeg, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba
About this study
Official title: Relative Effectiveness and Safety of Pharmacotherapeutic Agents for Patent Ductus Arteriosus (PDA) in Preterm Infants: A National Comparative Effectiveness Research (CER) Project
Patent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in preterm infants. Persistent PDA may result in higher rates of death, chronic lung disease (CLD), pulmonary hemorrhage, necrotizing enterocolitis (NEC), acute kidney injury (AKI), intraventricular hemorrhage (IVH) and cerebral palsy. Currently available options to treat a PDA include indomethacin, ibuprofen or acetaminophen followed by surgical or interventional closure of the PDA if medical therapy fails.
Wide variation exists in PDA treatment practices across Canada. A survey conducted through the Canadian Neonatal Network (CNN) in 2019 showed that the most common choice of initial pharmacotherapy is standard dose ibuprofen. In view of the high pharmacotherapy failure rate with standard dose ibuprofen, there is a growing use of higher doses of ibuprofen with increasing postnatal age (with 32% of respondents currently adopting this practice) in spite of the fact that effectiveness and safety of higher ibuprofen doses have not been established in extremely preterm infants [<29 weeks gestational age (GA)]. In view of this large practice variation across Canadian neonatal intensive care units (NICUs), we are planning a comparative effectiveness study of the different primary pharmacotherapeutic agents used to treat the PDA in preterm infants.
Read more
Aims Primary: To compare the primary pharmacotherapeutic practices for PDA closure and evaluate their impact on clinical outcomes in extremely preterm infants (<29 weeks GA) Secondary: To understand the relevance of pharmacotherapeutic PDA treatment with respect to clinical outcomes in the real world.
Methods:
Participants: Extremely preterm infants (<29 weeks gestational age) with an echocardiography confirmed PDA who will be treated according to attending team
Interventions:
- Standard dose ibuprofen [10-5-5 regimen, i.e., 10mg/kg followed by 2 doses of 5mg/kg at 24h intervals]
- Adjustable dose ibuprofen [10-5-5 regimen if treated within the first week. Higher doses of ibuprofen up to a 20-10-10 regimen if treated after the postnatal age cut-off for lower dose as per the local center policy]
- Intravenous indomethacin [0.1-0.3mg/kg every 12-24h for a total of 3 doses].
- Acetaminophen [Oral/intravenous] (15mg/kg every 6h) for 3-7 days
Outcomes:
Primary: Failure of primary pharmacotherapy (Need for further medical and/or surgical/interventional treatment following an initial course of pharmacotherapy).
Secondary: (a) Receipt of 2nd course of pharmacotherapy; (b) Surgical/interventional PDA closure; (c) CLD (d) NEC (stage 2 or greater) (e) Severe IVH (Grade III-IV) (f) Definite sepsis (g) Stage 1 or greater AKI; (h) Post-treatment serum bilirubin; (i) Phototherapy duration; (j) All-cause mortality during hospital stay.
Read the detailed description
In this study, we intend to generate real-world evidence (RWE) by analyzing real-world data (RWD) (defined as data generated during routine clinical practice) from a registry-based Comparative Effectiveness Research study.
The Canadian Neonatal Network (CNN) is a well-established patient registry that includes members from 31 hospitals and 17 universities across Canada. The Network maintains a standardized NICU database and provides a unique opportunity for researchers to participate in collaborative projects. We will use the principles of Hypotheses Evaluating Treatment Effectiveness (HETE) research, which are designed to evaluate the presence or absence of a pre-specified effect and/or its magnitude. The network has recent experience in conducting such a study where one CIHR-funded study to evaluate effectiveness of two modes of non-invasive ventilation in preterm infants is already underway in 20 NICUs across Canada.
The CNN's coordinating facility is located within the Maternal-Infant Care (MiCare) Research Center, Lunenfeld-Tanenbaum Research Institute (LTRI) at Mount Sinai Hospital (Toronto). Each participating site has highly trained abstractors who enter data from patient charts into the CNN database. The abstractors will also enter data specific to our project, which will allow us to obtain real-world data at a minimal cost with easy access to investigators for troubleshooting.
Statistical Analysis overview: Since the proposed study is a CER using RWD, we will examine and account for potential confounders at the analyses stage. As recommended for HETE studies using RWD, accuracy of results will be checked by performing complementary sensitivity analyses. The analyses will be conducted in 2 stages: unit-level protocol effectiveness analysis and a secondary drug-dosage effectiveness analysis.
- Conditions
- Patent Ductus Arteriosus, Extreme Prematurity
- Being tested
- Indomethacin, Ibuprofen, Acetaminophen
- Keywords
- indomethacin, ibuprofen, acetaminophen
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndomethacinDrug
Also called indocid
Intravenous formulation
IbuprofenDrug
Also called Advil, NeoProfen
Intravenous and oral formulations
AcetaminophenDrug
Also called paracetamol
Intravenous and oral formulations
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin Arm | Intravenous indomethacin at 0.1-0.3 mg/kg IV every 12-24h for a total of 3 doses as choice of initial pharmacotherapy. Receives: Drug: Indomethacin | |
| Standard dose ibuprofen Arm | Standard dose ibuprofen [Oral/intravenous] at 10 mg/kg followed by 2 doses of 5mg/kg at 24 h intervals irrespective of postnatal age as choice of initial pharmacotherapy. Receives: Drug: Ibuprofen | |
| Adjustable dose ibuprofen Arm | Adjustable dose ibuprofen [Oral/intravenous] as choice of initial pharmacotherapy. The dose of ibuprofen will be 10 mg/kg followed by 2 doses of 5 mg/kg at 24 h intervals if treated within the first 7 days after birth. Higher doses of ibuprofen up to 20 mg/kg followed by 2 doses of 10 mg/kg at 24 h intervals if treated after the postnatal age cut-off for lower dose as per the local center policy Receives: Drug: Ibuprofen | |
| Acetaminophen Arm | Acetaminophen [Oral/intravenous] at 15mg/kg every 6h for 3-7 days as choice of initial pharmacotherapy. Receives: Drug: Acetaminophen | |
| Control group | Infants <29 weeks GA with echocardiography-confirmed PDA but never received any pharmacotherapy | |
| Reference group | Infants <29 weeks GA who were never diagnosed with PDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of primary pharmacotherapy
Receipt of further medical and/or surgical/interventional treatment following an initial course of pharmacotherapy
Measured: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcomes (10)
Receipt of 2nd course of pharmacotherapy
Measured: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Surgical/interventional PDA closure
Measured: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Chronic lung disease
Oxygen or respiratory support requirement at 36 weeks' postmenstrual age or at discharge
Measured: birth through 36 weeks post menstrual age
Necrotizing enterocolitis
Stage 2 or greater as per Bell's criteria
Measured: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Severe intraventricular hemorrhage
Grade III-IV according to Papile Criteria
Measured: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Definite sepsis
Clinical symptoms and signs of sepsis and a positive bacterial culture in a specimen obtained from normally sterile fluids or tissue obtained at postmortem
Measured: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Acute Kidney Injury
Stage 1 or greater according to the Neonatal AKI KDIGO classification
Measured: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Post-treatment serum bilirubin
Measured: within 7 days of initiation of pharmacotherapy
Maximum serum AST and ALT (u/L) during treatment or within 1 week of treatment completion
Measured: within 7 days of completion of pharmacotherapy
All-cause mortality during hospital stay
Measured: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Jan 2020
- Primary completion31 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,663 participants (actual)
- Target duration
- 20 Weeks
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, Children's Hospital of Eastern Ontario, CHU de Quebec-Universite Laval, Foothills Medical Centre, Victoria General Hospital, The Hospital for Sick Children, Health Sciences Centre, Winnipeg, Manitoba, St. Justine's Hospital, Queen's University, MOUNT SINAI HOSPITAL, Royal Alexandra Hospital, Regina General Hospital, Royal University Hospital Foundation, St. Boniface Hospital, The Moncton Hospital, Horizon Health Network, Sunnybrook Health Sciences Centre, Windsor Regional Hospital, Royal Columbian Hospital Foundation, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, London Health Sciences Centre, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Souvik Mitra, MD MSc FRCPC, IWK Health Centre
- Investigators
- Souvik Mitra, MD, MSc, Principal investigator, IWK Health Center, Halifax, CanadaAmish Jain, MBBS, PhD, Principal investigator, Mount Sinai Hospital, CanadaPrakeshkumar Shah, MD, FRCPC, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347720
- Sponsor's protocol ID
- 1025627
- Acronym
- CANRxPDA
- Status last verified
- Jun 2024
- First submitted
- 12 Apr 2020
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mitra S, Jain A, Ting JY, Ben Fadel N, Drolet C, Abou Mehrem A, Soraisham A, Jasani B, Louis D, Lapointe A, Dorling J, Khurshid F, Hyderi A, Kumaran K, Bodani J, Weisz D, Alvaro R, Adie M, Stavel M, Morin A, Bhattacharya S, Kanungo J, Canning R, Ye XY, Hatfield T, Gardner CE, Shah P. Relative effectiveness and safety of pharmacotherapeutic agents for patent ductus arteriosus (PDA) in preterm infants: a protocol for a multicentre comparative effectiveness study (CANRxPDA). BMJ Open. 2021 May 5;11(5):e050682. doi: 10.1136/bmjopen-2021-050682.
PubMed 33952559
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Effectiveness and Safety of Pharmacotherapeutic Agents for Patent Ductus Arteriosus (PDA) in Preterm Infants: A National Comparative Effectiveness Research (CER) Project
- ClinicalTrials.gov ID
- NCT04347720
- Acronym / sponsor ID
- CANRxPDA / 1025627
- Conditions
- Patent Ductus Arteriosus, Extreme Prematurity
- Keywords
- indomethacin, ibuprofen, acetaminophen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,663 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, Children's Hospital of Eastern Ontario, CHU de Quebec-Universite Laval, Foothills Medical Centre, Victoria General Hospital, The Hospital for Sick Children, Health Sciences Centre, Winnipeg, Manitoba, St. Justine's Hospital, Queen's University, MOUNT SINAI HOSPITAL, Royal Alexandra Hospital, Regina General Hospital, Royal University Hospital Foundation, St. Boniface Hospital, The Moncton Hospital, Horizon Health Network, Sunnybrook Health Sciences Centre, Windsor Regional Hospital, Royal Columbian Hospital Foundation, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, London Health Sciences Centre, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Apr 2020 (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.
Patent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in preterm infants. Persistent PDA may result in higher rates of death, chronic lung disease (CLD), pulmonary hemorrhage, necrotizing enterocolitis (NEC), acute kidney injury (AKI), intraventricular hemorrhage (IVH) and cerebral palsy. Currently available options to treat a PDA include indomethacin, ibuprofen or acetaminophen followed by surgical or interventional closure of the PDA if medical therapy fails.
Wide variation exists in PDA treatment practices across Canada. A survey conducted through the Canadian Neonatal Network (CNN) in 2019 showed that the most common choice of initial pharmacotherapy is standard dose ibuprofen. In view of the high pharmacotherapy failure rate with standard dose ibuprofen, there is a growing use of higher doses of ibuprofen with increasing postnatal age (with 32% of respondents currently adopting this practice) in spite of the fact that effectiveness and safety of higher ibuprofen doses have not been established in extremely preterm infants [<29 weeks gestational age (GA)]. In view of this large practice variation across Canadian neonatal intensive care units (NICUs), we are planning a comparative effectiveness study of the different primary pharmacotherapeutic agents used to treat the PDA in preterm infants.
Aims Primary: To compare the primary pharmacotherapeutic practices for PDA closure and evaluate their impact on clinical outcomes in extremely preterm infants (<29 weeks GA) Secondary: To understand the relevance of pharmacotherapeutic PDA treatment with respect to clinical outcomes in the real world.
Methods:
Participants: Extremely preterm infants (<29 weeks gestational age) with an echocardiography confirmed PDA who will be treated according to attending team
Interventions:
- Standard dose ibuprofen [10-5-5 regimen, i.e., 10mg/kg followed by 2 doses of 5mg/kg at 24h intervals]
- Adjustable dose ibuprofen [10-5-5 regimen if treated within the first week. Higher doses of ibuprofen up to a 20-10-10 regimen if treated after the postnatal age cut-off for lower dose as per the local center policy]
- Intravenous indomethacin [0.1-0.3mg/kg every 12-24h for a total of 3 doses].
- Acetaminophen [Oral/intravenous] (15mg/kg every 6h) for 3-7 days
Outcomes:
Primary: Failure of primary pharmacotherapy (Need for further medical and/or surgical/interventional treatment following an initial course of pharmacotherapy).
Secondary: (a) Receipt of 2nd course of pharmacotherapy; (b) Surgical/interventional PDA closure; (c) CLD (d) NEC (stage 2 or greater) (e) Severe IVH (Grade III-IV) (f) Definite sepsis (g) Stage 1 or greater AKI; (h) Post-treatment serum bilirubin; (i) Phototherapy duration; (j) All-cause mortality during hospital stay.
Detailed description
In this study, we intend to generate real-world evidence (RWE) by analyzing real-world data (RWD) (defined as data generated during routine clinical practice) from a registry-based Comparative Effectiveness Research study.
The Canadian Neonatal Network (CNN) is a well-established patient registry that includes members from 31 hospitals and 17 universities across Canada. The Network maintains a standardized NICU database and provides a unique opportunity for researchers to participate in collaborative projects. We will use the principles of Hypotheses Evaluating Treatment Effectiveness (HETE) research, which are designed to evaluate the presence or absence of a pre-specified effect and/or its magnitude. The network has recent experience in conducting such a study where one CIHR-funded study to evaluate effectiveness of two modes of non-invasive ventilation in preterm infants is already underway in 20 NICUs across Canada.
The CNN's coordinating facility is located within the Maternal-Infant Care (MiCare) Research Center, Lunenfeld-Tanenbaum Research Institute (LTRI) at Mount Sinai Hospital (Toronto). Each participating site has highly trained abstractors who enter data from patient charts into the CNN database. The abstractors will also enter data specific to our project, which will allow us to obtain real-world data at a minimal cost with easy access to investigators for troubleshooting.
Statistical Analysis overview: Since the proposed study is a CER using RWD, we will examine and account for potential confounders at the analyses stage. As recommended for HETE studies using RWD, accuracy of results will be checked by performing complementary sensitivity analyses. The analyses will be conducted in 2 stages: unit-level protocol effectiveness analysis and a secondary drug-dosage effectiveness analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Weeks
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Indomethacin Arm | – | Drug: IndomethacinIntravenous indomethacin at 0.1-0.3 mg/kg IV every 12-24h for a total of 3 doses as choice of initial pharmacotherapy. |
| Standard dose ibuprofen Arm | – | Drug: IbuprofenStandard dose ibuprofen [Oral/intravenous] at 10 mg/kg followed by 2 doses of 5mg/kg at 24 h intervals irrespective of postnatal age as choice of initial pharmacotherapy. |
| Adjustable dose ibuprofen Arm | – | Drug: IbuprofenAdjustable dose ibuprofen [Oral/intravenous] as choice of initial pharmacotherapy. The dose of ibuprofen will be 10 mg/kg followed by 2 doses of 5 mg/kg at 24 h intervals if treated within the first 7 days after birth. Higher doses of ibuprofen up to 20 mg/kg followed by 2 doses of 10 mg/kg at 24 h intervals if treated after the postnatal age cut-off for lower dose as per the local center policy |
| Acetaminophen Arm | – | Drug: AcetaminophenAcetaminophen [Oral/intravenous] at 15mg/kg every 6h for 3-7 days as choice of initial pharmacotherapy. |
| Control group | – | –Infants <29 weeks GA with echocardiography-confirmed PDA but never received any pharmacotherapy |
| Reference group | – | –Infants <29 weeks GA who were never diagnosed with PDA |
Who may qualify
- Ages
- Up to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All infants born less than 29 weeks of gestation admitted to the participating sites will be included in the study. The population of interest will be those preterm infants <29 weeks gestational age (including outborns) with echocardiography confirmed PDA who will be treated according to attending team. Infants <29 weeks GA with echocardiography-confirmed PDA but never received treatment will be included as the control population. Infants <29 weeks GA who were never diagnosed with PDA will be included as the reference population
Key inclusion criteria (1 listed)
- Extremely preterm infants (<29 weeks gestational age) with an echocardiography confirmed PDA who will be treated according to attending team
Key exclusion criteria (1 listed)
- Any infant who received pharmacotherapy for a clinically symptomatic PDA without prior echocardiographic confirmation of the presence of PDA will be excluded from all analyses.
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 |
|---|---|---|
| IndomethacinAlso: indocidIntravenous formulation | Drug | Indomethacin Arm |
| IbuprofenAlso: Advil, NeoProfenIntravenous and oral formulations | Drug | Adjustable dose ibuprofen Arm, Standard dose ibuprofen Arm |
| AcetaminophenAlso: paracetamolIntravenous and oral formulations | Drug | Acetaminophen Arm |
Primary outcome
Failure of primary pharmacotherapy
Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Receipt of further medical and/or surgical/interventional treatment following an initial course of pharmacotherapy
10 secondary outcomes
Receipt of 2nd course of pharmacotherapy
Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Surgical/interventional PDA closure
Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Chronic lung disease
Time frame: birth through 36 weeks post menstrual age
Necrotizing enterocolitis
Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Severe intraventricular hemorrhage
Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Definite sepsis
Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Acute Kidney Injury
Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Post-treatment serum bilirubin
Time frame: within 7 days of initiation of pharmacotherapy
Maximum serum AST and ALT (u/L) during treatment or within 1 week of treatment completion
Time frame: within 7 days of completion of pharmacotherapy
All-cause mortality during hospital stay
Time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 33952559Mitra S, Jain A, Ting JY, Ben Fadel N, Drolet C, Abou Mehrem A, Soraisham A, Jasani B, Louis D, Lapointe A, Dorling J, Khurshid F, Hyderi A, Kumaran K, Bodani J, Weisz D, Alvaro R, Adie M, Stavel M, Morin A, Bhattacharya S, Kanungo J, Canning R, Ye XY, Hatfield T, Gardner CE, Shah P. Relative effectiveness and safety of pharmacotherapeutic agents for patent ductus arteriosus (PDA) in preterm infants: a protocol for a multicentre comparative effectiveness study (CANRxPDA). BMJ Open. 2021 May 5;11(5):e050682. doi: 10.1136/bmjopen-2021-050682.
- Project funding information on the Canadian Institutes of Health Research (CIHR) Funding Decision DatabaseLink provided by the sponsor.
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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.
Souvik Mitra, MD, MSc principal investigator
IWK Health Center, Halifax, Canada
Amish Jain, MBBS, PhD principal investigator
Mount Sinai Hospital, Canada
Prakeshkumar Shah, MD, FRCPC principal investigator
Mount Sinai Hospital, Canada
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus and Extreme Prematurity, run by IWK Health Centre at 22 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Failure of primary pharmacotherapy (time frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347720, which also lists 1 linked publication.
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 21 Jun 2024.