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New iPad app aims to help parents navigate tough choices in extreme preterm birth

NCT ID NCT05264779

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests an iPad app called Periviable GOALS that helps parents facing a very early preterm birth (22-25 weeks) understand their options and clarify their values. The app includes videos and outcome information designed for people with varying literacy levels. Researchers will measure whether using the app improves shared decision-making and satisfaction among 300 parents at multiple hospitals.

What this could mean

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

Active substance
Periviable GOALS decision support tool (iPad app with videos and outcome information)
What this could lead to
If it works, this tool could help parents and doctors make more informed, less stressful decisions about care for extremely premature babies.
What could go wrong
This is a behavioral intervention trial, not a drug or device. It may not change outcomes for babies, and results may not apply to all hospitals or families.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

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

Started

Jun 2022

Expected to finish

Feb 2027

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.

Ages

18 years and older

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 for Pregnant Persons: * Adults (18 years or older) * Pregnant between 22 0/7 to 25 6/7 weeks gestation (this window may be slightly different for each recruitment site, as the gestational window that defines periviable delivery varies by institution). * Presenting to Labor \& Delivery at an approved study site with a pregnancy complication that poses the potential threat of or need for periviable delivery (e.g., rupture of membranes, preterm labor, shortened cervix, pre-eclampsia, and growth restriction). * Must have been counseled on their neonatal treatment options (e.g. resuscitation, comfort care) by their healthcare team prior to being approached by the study team. Inclusion Criteria for Important Others: * Adults (18 years or older) * 1 per pregnant person * Is identified by the pregnant person as someone who will be involved in making decisions for the baby * Must be present at the time of randomization to participate Exclusion Criteria: * Under 18 years of age * Incarcerated * Medically unstable (i.e. in active labor and dilated 6cm or more) * Emotionally unstable * Have not been counseled by their healthcare team regarding neonatal treatment options * Are not admitted to Labor \& Delivery for reasons indicative of a threatened early delivery * If they are experiencing a known fatal fetal anomaly * Are not present at the time of randomization (only for important others)

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Conditions

The condition(s) this trial relates to.

Obstetric Labor Complications Obstetric Labor, Premature pregnancy disorder Premature Birth

As listed by the trial registrant

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

Obstetric labor complications Obstetric labor, premature Pregnancy complications Pregnancy preterm Premature birth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brown University

    NOT_YET_RECRUITING

    Providence, Rhode Island, 02912, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of California San Diego

    RECRUITING

    San Diego, California, 92121, United States

  • The University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • The University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

  • The University of Texas at Austin

    RECRUITING

    Austin, Texas, 78712, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Massachusetts

    RECRUITING

    Worcester, Massachusetts, 01605, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

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