Evaluation of the Acceptability and Feasibility of a Bedtime Routine for Neonates

Johnson & Johnson (J&J)

Status: Completed

Conditions: Newborn

Treatments: Other: Body Lotion; Other: Daily Activities; Other: Baby Wash/Shampoo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06318637

CCSSKB005432

Details and patient eligibility

About

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

Enrollment: 132 patients

Sex: All

Ages: 2+ weeks old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Daily Activities

Interventional Group (Wash/Shampoo and Lotion)

Experimental group

Description:

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.

Treatment:

Other: Baby Wash/Shampoo

Other: Body Lotion