NewbornNCT06318637
Evaluation of the Acceptability and Feasibility of a Bedtime Routine for Neonates
A study testing Daily Activities and Body Lotion in people with Newborn, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns. Read more about this study
- Who is it for?
- Ages 2 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Newborn
- What is being tested?
- Daily Activities and Body Lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Evaluation of the Acceptability and Feasibility to Caregivers of a Bedtime Routine for Neonates
The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.
- Conditions
- Newborn
- Being tested
- Baby Wash/Shampoo, Daily Activities, Body Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby Wash/ShampooOther
Marketed baby wash/shampoo to be used as needed.
Daily ActivitiesOther
Participants to follow their typical daily activities with their baby.
Body LotionOther
Marketed body lotion to be used as needed.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants in the control group will follow their typical daily activities with their baby throughout the study, including their typical bathing, skincare, and sleep practices. Receives: Other: Daily Activities |
| Interventional Group (Wash/Shampoo and Lotion) | Experimental | Participants in the intervention group will use the provided wash/shampoo, and face and body lotion for their baby. At Baseline, participants caregivers in the intervention group will be provided with instructions for institution of a daily bedtime routine for their infant, which includes a massage with a moisturizing lotion. Receives: Other: Baby Wash/Shampoo; Other: Body Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bedtime Routine Acceptability and Feasibility to Caregivers
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
Measured: At Day 10
Bedtime Routine Acceptability and Feasibility to Caregivers
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
Measured: At Day 17
Bedtime Routine Acceptability and Feasibility to Caregivers
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
Measured: At 3 months
Bedtime Routine Acceptability and Feasibility to Caregivers
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start18 Apr 2024
- Primary completion12 Aug 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Rodgers, Ph.D., Principal investigator, SGS North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318637
- Sponsor's protocol ID
- CCSSKB005432
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Acceptability and Feasibility to Caregivers of a Bedtime Routine for Neonates
- ClinicalTrials.gov ID
- NCT06318637
- Acronym / sponsor ID
- CCSSKB005432
- Conditions
- Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Daily ActivitiesParticipants in the control group will follow their typical daily activities with their baby throughout the study, including their typical bathing, skincare, and sleep practices. |
| Interventional Group (Wash/Shampoo and Lotion) | Experimental | Other: Baby Wash/Shampoo, Other: Body LotionParticipants in the intervention group will use the provided wash/shampoo, and face and body lotion for their baby. At Baseline, participants caregivers in the intervention group will be provided with instructions for institution of a daily bedtime routine for their infant, which includes a massage with a moisturizing lotion. |
Who may qualify
- Ages
- 2 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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.)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby Wash/ShampooMarketed baby wash/shampoo to be used as needed. | Other | Interventional Group (Wash/Shampoo and Lotion) |
| Daily ActivitiesParticipants to follow their typical daily activities with their baby. | Other | Control Group |
| Body LotionMarketed body lotion to be used as needed. | Other | Interventional Group (Wash/Shampoo and Lotion) |
Primary outcome
Bedtime Routine Acceptability and Feasibility to Caregivers
Time frame: At Day 10
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
Bedtime Routine Acceptability and Feasibility to Caregivers
Time frame: At Day 17
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
Bedtime Routine Acceptability and Feasibility to Caregivers
Time frame: At 3 months
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
Bedtime Routine Acceptability and Feasibility to Caregivers
Time frame: At 6 months
Will collect agreement data to statements on bedtime routine acceptability using a 5-point Likert scale, ranging from strongly agree to strongly disagree. Will collect bedtime routine information, including wash up/bath, massage/apply lotion and quiet activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Rodgers, Ph.D. principal investigator
SGS North America, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Activities and Body Lotion in people with Newborn, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bedtime Routine Acceptability and Feasibility to Caregivers (time frame: At Day 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.