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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06318637
Other study ID # CCSSKB005432
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 18, 2024
Est. completion date December 23, 2024

Study information

Verified date May 2024
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact Robert Vera
Phone +01 972 392 1529
Email Robert.Vera@sgs.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 23, 2024
Est. primary completion date December 23, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Weeks and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
United States SGS North America, Inc. Richardson Texas

Sponsors (1)

Lead Sponsor Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At Day 10
Primary 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. At Day 17
Primary 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. At 3 months
Primary 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. At 6 months
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