Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
NCT ID: NCT05011149
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2022-01-10
2024-09-30
Brief Summary
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Purpose of the study: The overall purpose of this pilot study is to assess the feasibility of conducting a large study to explore the following research question: In preterm infants born \<26 weeks' gestation, is a strategy of selective early medical treatment of a symptomatic PDA better than no treatment at all in the first week of life?
The main feasibility objectives of this study are:
1. To assess how many eligible infants can be enrolled in the study
2. To assess how many enrolled infants properly complete the study protocol
Importance: To our knowledge this will be the first study on PDA management in preterm infants that specifically aims to enroll preterm infants born at \<26 weeks of gestational age who are at the highest risk for PDA-related problems but have been mostly under-represented in previous PDA studies.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Selective early medical treatment (SMART) strategy
Infants who are randomized to experimental group will follow the SMART treatment protocol, which includes echocardiographic screening every 72 hours to categorize PDA disease severity by combining clinical and echocardiographic features. At any evaluation if patients are found to have a "severe PDA" on echocardiography, irrespective of clinical symptoms, or a "moderate PDA" on echocardiography with at least moderate clinical illness, they will receive pharmacotherapy aimed at PDA closure (The PDA severity has been divided into mild, moderate or severe based on pre-defined clinical and echocardiographic criteria).
Ibuprofen
Pharmacotherapy, when indicated (ie, for "severe PDA" on echocardiography, irrespective of clinical symptoms, or a "moderate PDA" on echocardiography with at least moderate clinical illness), will be provided in the form of ibuprofen as first line agent at a standard dosing of 10 mg/kg followed by 2 doses of 5mg/kg every 24 h. The route of administration may be intravenous or enteral, as determined by the treating team.
For treated infants, follow-up echocardiography will be conducted at the end of the 3-day course and second course of treatment will be initiated if they still fulfill study treatment criteria as mentioned above. If any treatment-eligible infant has a contraindication to ibuprofen, use of acetaminophen will be permitted as an alternative agent.
Early conservative management strategy
Infants randomized to this arm will not undergo any further echocardiographic assessment or pharmacological treatment of the PDA regardless of the clinical signs. If the infant gets an echocardiographic assessment for a reason different than PDA assessment (such as hypotension or oxygenation failure) and a PDA is incidentally noted that fits the treatment criteria, the infant will not be initiated on pharmacotherapy. After 7 days of age, decision on PDA assessment and treatment will be at the discretion of the treating physician.
No interventions assigned to this group
Interventions
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Ibuprofen
Pharmacotherapy, when indicated (ie, for "severe PDA" on echocardiography, irrespective of clinical symptoms, or a "moderate PDA" on echocardiography with at least moderate clinical illness), will be provided in the form of ibuprofen as first line agent at a standard dosing of 10 mg/kg followed by 2 doses of 5mg/kg every 24 h. The route of administration may be intravenous or enteral, as determined by the treating team.
For treated infants, follow-up echocardiography will be conducted at the end of the 3-day course and second course of treatment will be initiated if they still fulfill study treatment criteria as mentioned above. If any treatment-eligible infant has a contraindication to ibuprofen, use of acetaminophen will be permitted as an alternative agent.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* congenital heart disease (excluding patent foramen ovale, atrial septal defect or ventricular septal defect with a defect size less than 2mm)
* other major congenital anomaly
* decision to withhold/withdraw care
72 Hours
ALL
No
Sponsors
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BC Children's Hospital Research Institute
OTHER
CHU de Quebec-Universite Laval
OTHER
Sunnybrook Health Sciences Centre
OTHER
Mount Sinai Hospital, Canada
OTHER
Sharp Mary Birch Hospital for Women & Newborns
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Dalhousie Medical Research Foundation
UNKNOWN
Children's Hospital of Orange County, OC, California, United States
UNKNOWN
University of Alberta
OTHER
University of Oklahoma
OTHER
IWK Health Centre
OTHER
Responsible Party
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Dr. Souvik Mitra, MD MSc FRCPC
Associate Professor & Neonatologist
Principal Investigators
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Souvik Mitra, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University & IWK Health
Locations
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Children's Hospital of Orange County
Orange, California, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
OU College of Medicine, University of Oklahoma
Oklahoma City, Oklahoma, United States
Stollery Children's Hospital
Edmonton, Alberta, Canada
British Columbia Women's Hospital
Vancouver, British Columbia, Canada
IWK Health Center
Halifax, Nova Scotia, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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John Cleary
Role: primary
Marjorie Makoni, MD
Role: primary
Abbas Hyderi
Role: primary
Michael Castaldo
Role: primary
Souvik Mitra
Role: primary
Audrey Hébert
Role: primary
References
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Mitra S, Hebert A, Castaldo M, Disher T, El-Naggar W, Dhillon S, Alhassen Z, Koo J, Katheria AC, Hyderi A, Kumaran K, Makoni M, Weisz DE, Jain A, Bacchini F, Cameron A, Hatfield T, Dorling J, McNamara PJ, Thabane L. Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial protocol (SMART-PDA). BMJ Open. 2024 Jul 24;14(7):e087998. doi: 10.1136/bmjopen-2024-087998.
Related Links
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Project funding information on the Canadian Institutes of Health Research (CIHR) Funding Decision Database
Other Identifiers
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459750
Identifier Type: -
Identifier Source: org_study_id
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