Selective Early Medical Treatment of the Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot Randomized Controlled Trial

Who is this study for? Extremely low gestational age infants with patent ductus arteriosus
What treatments are being studied? Ibuprofen
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Background: Among preterm infants, those born at a gestational age less than 26 weeks are considered the most vulnerable with a high risk of short- and long-term health problems that include chronic lung disease, brain bleeds, gut injury, kidney failure and death. Patent ductus arteriosus (PDA) is the most common heart condition with almost 70% preterm infants in this gestational age group being diagnosed with a PDA. Though many PDAs spontaneously resolve on their own, research suggests that if the PDA persists, it may contribute to a number of these short- and long-term health problems. Non-steroidal anti-inflammatory medications such as ibuprofen are commonly used to treat a PDA. Such drugs can also have harmful effects on the gut and kidneys of extremely preterm infants. Therefore, we are unsure if early treatment of a symptomatic PDA in this age group is at all beneficial. Given the wide variation in PDA treatment approaches in this age group, a randomized trial design, where extremely preterm infants with a symptomatic PDA are randomly assigned to early treatment or no early treatment, is essential to address this question. 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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 days
Healthy Volunteers: f
View:

• Preterm infants less than 26 completed weeks (i.e., up to and including 25 weeks and 6 days) of gestation

Locations
United States
California
Children's Hospital of Orange County
RECRUITING
Orange
Sharp Mary Birch Hospital for Women & Newborns
TERMINATED
San Diego
Oklahoma
OU College of Medicine, University of Oklahoma
RECRUITING
Oklahoma City
Other Locations
Canada
Stollery Children's Hospital
RECRUITING
Edmonton
IWK Health Center
RECRUITING
Halifax
Centre Hospitalier Universitaire de Quebec
RECRUITING
Québec
Mount Sinai Hospital
WITHDRAWN
Toronto
Sunnybrook Health Sciences Centre
WITHDRAWN
Toronto
British Columbia Women's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Souvik Mitra, MD, MSc
souvik.mitra@iwk.nshealth.ca
+1-902-470-6490
Backup
Amish Jain, MBBS, PhD
amish.jain@sinaihealth.ca
Time Frame
Start Date: 2022-01-10
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 100
Treatments
Experimental: 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).
No_intervention: 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.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), CHU de Quebec-Universite Laval, Dalhousie Medical Research Foundation, BC Children's Hospital Research Institute, Children's Hospital of Orange County, OC, California, United States, University of Oklahoma, University of Alberta, Mount Sinai Hospital, Canada, Sunnybrook Health Sciences Centre, Sharp Mary Birch Hospital for Women & Newborns
Leads: IWK Health Centre

This content was sourced from clinicaltrials.gov