Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial (SMART-PDA).
Souvik Mitra, Audrey Hebert, Michael P Castaldo...
https://pubmed.ncbi.nlm.nih.gov/42150872Actively Recruiting
Phase 3
Age: 0 - 72Hours
All Genders
ID05011149
Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants A Pilot Randomized Controlled Trial
Led by IWK Health Centre · Updated on 2024-06-21
100
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
I
IWK Health Centre
Lead Sponsor
B
BC Children's Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the best approach to managing patent ductus arteriosus (PDA) in extremely preterm infants born before 26 weeks of gestation. PDA is a common heart condition in this vulnerable group, affecting nearly 70% of these infants, and is linked to serious short- and long-term health complications. This pilot randomized controlled trial aims to assess the feasibility of a larger study comparing selective early medical treatment versus no early treatment of symptomatic PDA during the first week of life. The study randomly assigns infants to one of two groups. The experimental group follows a selective early medical treatment protocol involving echocardiographic screening every 72 hours to evaluate PDA severity using clinical and imaging features. If criteria for moderate or severe PDA are met, infants receive ibuprofen pharmacotherapy aimed at closing the PDA. The control group receives early conservative management without further PDA assessments or treatments during the first week. After 7 days, PDA care decisions are left to the treating physician. During the trial, researchers monitor enrollment rates and protocol adherence as primary outcomes at 7 days postnatal age. Secondary outcomes include safety assessments, data completeness, mortality, PDA closure methods, lung and brain health measures, and hospitalization duration through discharge at approximately 20 weeks postnatal age. The study collects clinical data, echocardiography results, and treatment details, aiming to improve PDA management strategies for this high-risk population.
CONDITIONS
Brief Title
Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
Who Can Participate
Age: 0 - 72Hours
All Genders
Eligibility Criteria
You may qualify if you...
- Preterm infants less than 26 completed weeks (up to and including 25 weeks and 6 days) of gestation
You will not qualify if you...
- No PDA on initial screening echocardiography
- Congenital heart disease excluding patent foramen ovale, atrial septal defect, or ventricular septal defect smaller than 2mm
- Other major congenital anomalies
- Decision to withhold or withdraw care
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 7 days postnatal age
Participants randomized to the experimental group receive selective early medical treatment with ibuprofen or acetaminophen if indicated based on echocardiographic and clinical criteria. Participants randomized to the control group receive early conservative management without pharmacological treatment.
Echocardiographic screening every 72 hours; pharmacotherapy course of 3 days with possible second course if needed
Follow-up
Duration - Through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Participants are monitored through hospital discharge for clinical outcomes including mortality, complications, and need for surgical or additional interventions.
Ongoing clinical assessments during hospital stay
Trial Site Locations
Total: 9 locations
1
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
2
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
Terminated
3
OU College of Medicine, University of Oklahoma
Oklahoma City, Oklahoma, United States, 73117
Actively Recruiting
4
Stollery Children's Hospital
Edmonton, Alberta, Canada
Actively Recruiting
5
British Columbia Women's Hospital
Vancouver, British Columbia, Canada
Actively Recruiting
6
IWK Health Center
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
7
Mount Sinai Hospital
Toronto, Ontario, Canada
Withdrawn
8
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Withdrawn
9
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Actively Recruiting
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Research Team
S
Souvik Mitra, MD, MSc
A
Amish Jain, MBBS, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial protocol (SMART-PDA).
Souvik Mitra, Audrey Hébert, Michael Castaldo...
https://pubmed.ncbi.nlm.nih.gov/39053961