Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT

Status unconfirmed · Phase 3

Conditions studied: Patent Ductus Arteriosus After Premature Birth

In brief

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.

Key facts

Study ID

NCT05011149

Run by

IWK Health Centre

People needed

100

Starts

2022-01-10

Expected to finish

2024-09-30

Last updated by the study team

2024-06-21

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• no PDA on initial screening echocardiography
• 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

Where it is running

• Centre Hospitalier Universitaire de Quebec — Québec, Quebec, Canada (enrolling)
• British Columbia Women's Hospital — Vancouver, British Columbia, Canada (enrolling)
• IWK Health Center — Halifax, Nova Scotia, Canada (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• OU College of Medicine, University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Stollery Children's Hospital — Edmonton, Alberta, Canada (enrolling)
• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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