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Premature baby heart study aims to uncover hidden risks

NCT ID NCT02016599

Knowledge-focused Sponsor: University of Iowa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is closely watching heart and lung changes in extremely low birth weight babies (under 1000 grams) during their first week of life. Researchers want to understand why some preemies develop low blood pressure and related complications. By using standard and new monitoring methods, they hope to find early warning signs that could improve care for these fragile infants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand and predict heart and lung problems in premature babies, potentially leading to earlier interventions.
What could go wrong
This is an observational study, not a treatment trial. It aims to gather information, not to test a new therapy, so direct benefits for participants are unlikely.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Dec 2032

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

All ELBW infants are eligible for enrollment. There will not be a placebo group. Data from the first 100 patients will be used to develop the clinical deterioration indices and data from the next 100 patients will be used to validate the indices.

Ages

Up to 1 week

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: * Infant born at less than or equal to 1000 grams * Admitted to NICU Exclusion Criteria: * Infant does not meet inclusion criteria * Infant has life-threatening congenital defect * Infant has congenital hydrops

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Conditions

The condition(s) this trial relates to.

hypotensive disorder

As listed by the trial registrant

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

Hypotension Neonatal prematurity

Contacts and locations

Locations

  • University of Iowa

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.