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New bassinet aims to make Skin-to-Skin contact safer for newborns

NCT ID NCT06533449

Knowledge-focused Sponsor: Johns Hopkins University 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a special bassinet designed to keep mother and baby together safely after birth. 160 new mothers used either the new Couplet Care bassinet or a standard one. Researchers surveyed mothers about sleep, breastfeeding, and satisfaction, and reviewed medical charts. The goal was to see if the new design improves safety and experience for skin-to-skin contact and rooming-in.

What this could mean

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

Active substance
Couplet Care Bassinet (a redesigned hospital bassinet)
What this could lead to
If successful, this bassinet could help hospitals safely support skin-to-skin contact and rooming-in, improving breastfeeding and maternal satisfaction.
What could go wrong
This is a small, completed study focused on patient experience and safety outcomes, not a treatment. Results may not apply to all hospitals or populations.

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

160 people

The number who actually took part.

Started

Jan 2025

Finished

May 2026

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

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: (from protocol) * postpartum female participant * at least 18 years of age * who can communicate in English Exclusion Criteria: * If postpartum female has had multiple infants (twins or more) or * participant has an infant who is not rooming-in, such as for infant or maternal intensive care

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Conditions

The condition(s) this trial relates to.

Breast Feeding Patient Satisfaction sleep disorder

As listed by the trial registrant

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

Breastfeeding Patient satisfaction Sleep

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

More trials for these conditions

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