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Newborn bedtime routine study: is it doable for parents?

NCT ID NCT06318637

Knowledge-focused Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether parents of newborns find a simple bedtime routine (bath, lotion massage, and quiet activity) acceptable and easy to do. 132 families took part. The goal was to see if such a routine is practical for caregivers, not to test any medical treatment.

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

132 people

The number who actually took part.

Started

Apr 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

2 weeks and older

Sex

Anyone

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: Infant: * Full term at birth (gestational age greater than or equal to \[\>=\] 37 weeks) * A singleton birth. (Having other infants/children in the household will be allowed but only 1 child per household may be enrolled) * Breastfed, formula-fed, or combination Caregiver: * Able to read, write, speak, and understand English * Must be the parent (biological or adoptive) and legal guardian of the infant participant who is willing and able to present proof of legal guardianship (example: birth certificate/hospital discharge paperwork along with valid ID of legal guardian, etc.) Exclusion Criteria: Caregiver and infant: * Has known allergies or adverse reactions to common topical skincare products or the ingredients in the investigational study materials * Has a history of or a concurrent health condition/situation which, in the opinion of the Principal Investigator (PI) or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study * Is simultaneously participating in any other clinical study or has participated in a clinical study since infant's birth * Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor * Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, or erythema)

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As listed by the trial registrant

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

Newborn

Contacts and locations

Locations

  • SGS North America, Inc.

    Richardson, Texas, 75081, United States

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