Newborn
Conditions
Brief summary
The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.
Interventions
OTHERBaby Wash/Shampoo
Marketed baby wash/shampoo to be used as needed.
OTHERDaily Activities
Participants to follow their typical daily activities with their baby.
OTHERBody Lotion
Marketed body lotion to be used as needed.
Sponsors
Johnson & Johnson Consumer Inc. (J&JCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Weeks to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bedtime Routine Acceptability and Feasibility to Caregivers | 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. |
Countries
United States
Outcome results
None listed