RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-10
Study Completion:2024-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05011149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 72 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Preterm infants less than 26 completed weeks (i.e., up to and including 25 weeks and 6 days) of gestation
  1. * no PDA on initial screening echocardiography
  2. * congenital heart disease (excluding patent foramen ovale, atrial septal defect or ventricular septal defect with a defect size less than 2mm)
  3. * other major congenital anomaly
  4. * decision to withhold/withdraw care

Contacts and Locations

Study Contact

Souvik Mitra, MD, MSc
CONTACT
+1-902-470-6490
souvik.mitra@iwk.nshealth.ca
Amish Jain, MBBS, PhD
CONTACT
amish.jain@sinaihealth.ca

Principal Investigator

Souvik Mitra, MD, MSc
PRINCIPAL_INVESTIGATOR
Dalhousie University & IWK Health

Study Locations (Sites)

Children's Hospital of Orange County
Orange, California, 92868
United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
United States
OU College of Medicine, University of Oklahoma
Oklahoma City, Oklahoma, 73117
United States

Collaborators and Investigators

Sponsor: IWK Health Centre

  • Souvik Mitra, MD, MSc, PRINCIPAL_INVESTIGATOR, Dalhousie University & IWK Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-10
Study Completion Date2024-09-30

Study Record Updates

Study Start Date2022-01-10
Study Completion Date2024-09-30

Terms related to this study

Keywords Provided by Researchers

  • extremely preterm infant
  • early medical treatment
  • randomized controlled trial

Additional Relevant MeSH Terms

  • Patent Ductus Arteriosus After Premature Birth