Newborn Clinical Trial
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | SGS North America, Inc. | Richardson | Texas |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Consumer Inc. (J&JCI) |
United States,
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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