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NCT05011149 · ClinicalTrials.gov registry record · Phase 3
Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
A Phase 3 study of Patent Ductus Arteriosus After Premature Birth, sponsored by IWK Health Centre.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 9
- Study locations
NCT05011149 is a Phase 3 study of Patent Ductus Arteriosus After Premature Birth that is actively recruiting participants, run by IWK Health Centre. The registered enrollment target is 100 participants. The trial reports 9 study locations across 7 states.
The verdict
NCT05011149, a Phase 3 study of Patent Ductus Arteriosus After Premature Birth, is actively recruiting participants, sponsored by IWK Health Centre.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Ibuprofen
Study Locations (9)
California
- Children's Hospital of Orange County - Orange
- Sharp Mary Birch Hospital for Women & Newborns - San Diego
Ontario
- Mount Sinai Hospital - Toronto
- Sunnybrook Health Sciences Centre - Toronto
Oklahoma
- OU College of Medicine, University of Oklahoma - Oklahoma City
Alberta
- Stollery Children's Hospital - Edmonton
British Columbia
- British Columbia Women's Hospital - Vancouver
Nova Scotia
- IWK Health Center - Halifax
Quebec
- Centre Hospitalier Universitaire de Quebec - Québec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-01-10 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05011149
The ClinicalTrials.gov registry entry for NCT05011149 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IWK Health Centre, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Patent Ductus Arteriosus After Premature Birth appearing as the primary indexed condition, and to 1 intervention - of which Ibuprofen is the first listed.
NCT05011149 reports 9 study locations spanning 7 distinct geographic areas - top geographies include California, Ontario, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05011149 about?
NCT05011149 is a clinical study titled "Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT". 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 t...
What is the current status of trial NCT05011149?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2022-01-10. Estimated completion is 2024-09-30.
What conditions does trial NCT05011149 study?
This clinical trial studies the following conditions: Patent Ductus Arteriosus After Premature Birth.
What interventions are being tested in trial NCT05011149?
The interventions under investigation include: Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT05011149?
This trial is sponsored by IWK Health Centre, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05011149 being conducted?
This trial has 9 study locations across California, Oklahoma, Alberta, British Columbia, Nova Scotia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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