Evaluation of the Acceptability and Feasibility of a Bedtime Routine for Neonates
NCT ID: NCT06318637
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2024-04-18
2025-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control Group
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.
Daily Activities
Participants to follow their typical daily activities with their baby.
Interventional Group (Wash/Shampoo and Lotion)
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.
Baby Wash/Shampoo
Marketed baby wash/shampoo to be used as needed.
Body Lotion
Marketed body lotion to be used as needed.
Interventions
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Baby Wash/Shampoo
Marketed baby wash/shampoo to be used as needed.
Daily Activities
Participants to follow their typical daily activities with their baby.
Body Lotion
Marketed body lotion to be used as needed.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
2 Weeks
ALL
Yes
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Nancy Rodgers, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
SGS North America, Inc.
Locations
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SGS North America, Inc.
Richardson, Texas, United States
Countries
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Other Identifiers
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CCSSKB005432
Identifier Type: -
Identifier Source: org_study_id
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