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Can a doula in the NICU ease Parents' trauma?

NCT ID NCT06521398

Symptom relief Sponsor: University of Pennsylvania 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether providing doula support and care coordination to parents of preterm babies in the NICU can reduce stress, depression, and anxiety. Twenty English-speaking mothers of babies born before 34 weeks are being recruited. The doula helps connect families to mental health and medical services, and continues support after the baby leaves the hospital.

What this could mean

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

Active substance
Doula support and care coordination
What this could lead to
If it works, this could point toward a simple, low-cost way to improve mental health for parents of preterm babies in the NICU.
What could go wrong
This is a very small early trial with only 20 participants, so results may not apply to everyone. The intervention is supportive, not medical, so it may not reduce severe mental health conditions.

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 20 people

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

Started

Sep 2024

Expected to finish

Aug 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

16 years and older

Sex

Female participants only

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: * HUP postpartum patients who are at least 16 years old at the time their newborns' birth * Infant born at HUP * Preterm birth \<34 weeks * English language speaking Exclusion Criteria: * Unable to read or sign informed consent * Parents of infants transferred into HUP NICU * If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks * HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth

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Conditions

The condition(s) this trial relates to.

Premature Birth post-traumatic stress disorder prevention target postpartum depression prevention target

As listed by the trial registrant

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

Postpartum anxiety Postpartum depression Premature birth Stress disorders, post-traumatic

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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