Recruiting
Phase 3

Patent Ductus Arteriosus

Sponsor:

IWK Health Centre

Code:

NCT05011149

Conditions

Patent Ductus Arteriosus After Premature Birth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Ibuprofen

Study Details

Brief 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

Patent Ductus Arteriosus After Premature Birth

Study ID

NCT05011149

Start date

Jan 10, 2022

Status verified date

Jun, 2024

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Ibuprofen

Pharmacotherapy, when indicated (ie, for "severe PDA" on echocardiography, irrespective of clinical symptoms, or a "moderate PDA" on echocardiography with at least moderate clinical illness), will be provided in the form of ibuprofen as first line agent at a standard dosing of 10 mg/kg followed by 2 doses of 5mg/kg every 24 h. The route of administration may be intravenous or enteral, as determined by the treating team.

For treated infants, follow-up echocardiography will be conducted at the end of the 3-day course and second course of treatment will be initiated if they still fulfill study treatment criteria as mentioned above. If any treatment-eligible infant has a contraindication to ibuprofen, use of acetaminophen will be permitted as an alternative agent.

Primary outcome measure

  • Proportion of eligible infants recruited during the study period [ Time Frame: 7 days postnatal age ]
  • Proportion of randomized infants with no reported protocol deviations [ Time Frame: 7 days postnatal age ]

Central Contacts and Locations

Central contacts

Souvik Mitra, MD, MSc

+1-902-470-6490souvik.mitra@iwk.nshealth.ca

Amish Jain, MBBS, PhD

amish.jain@sinaihealth.ca

Locations

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

OU College of Medicine, University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Stollery Children's Hospital

Recruiting

Edmonton, Alberta, Canada

British Columbia Women's Hospital

Recruiting

Vancouver, British Columbia, Canada

IWK Health Center

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Centre Hospitalier Universitaire de Quebec

Recruiting

Québec City, Quebec, Canada

More Information

Sponsor

IWK Health Centre

Last update posted

Jun 21, 2024

Last verified

Jun, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2024-06-21.