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Study aims to predict which preterm babies need treatment for a heart vessel that often closes on its own

NCT ID NCT03782610

Knowledge-focused Sponsor: Nationwide Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 526 preterm infants born before 30 weeks who have a condition called patent ductus arteriosus (PDA), where a fetal blood vessel stays open too long. Researchers collect heart ultrasound, blood, and urine tests over the first month to predict which babies will close the vessel on their own and which are at risk for lung or brain problems. The goal is to avoid unnecessary treatments and focus care on infants who truly need it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

526 people

The number who actually took part.

Started

Apr 2019

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A cohort of consecutively enrolled preterm infants born between 23- and 30-weeks gestation with patent ductus arteriosus (PDA) documented on echocardiogram within 72-hours postnatal.

Ages

Up to 72 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Born between 23-weeks + 0 days (23\_0/7 wks) and 29-weeks + 6 days (29\_6/7 wks) gestation, inclusive * Admitted to a study neonatal intensive care unit (NICU) within 72-hours of birth * PDA noted on initial screening echo at \<72 postnatal hours Exclusion Criteria: * Life-threatening congenital abnormalities, including congenital heart disease (other than PDA or small atrial septal defects/patent foramen ovale/muscular VSD) * Parents have chosen to allow natural death (placed a do not resuscitate order)

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia patent ductus arteriosus Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchopulmonary dysplasia Neurodevelopmental abnormality Patent ductus arteriosus Preterm infant

Contacts and locations

Locations

  • Nationwide Children's Hospital Main Campus Neonatal Intensive Care Unit

    Columbus, Ohio, 43205, United States

  • Nationwide Children's Hospital Neonatal Intensive Care Unit at OhioHealth Grant Medical Center

    Columbus, Ohio, 43215, United States

  • Nationwide Children's Neonatal Intensive Care Unit at OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Nationwide Children's Neonatal Intensive Care Unit at The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

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