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

Not Applicable

Recruiting

• Conditions: Newborn
• Interventions: Other: Baby Wash/Shampoo; Other: Daily Activities; Other: Body Lotion

• Registration Number: NCT06318637
• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-19
• Study Start: 2024-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-08-18
• Study Completion: 2025-08-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Group (Wash/Shampoo and Lotion)	Body 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.
Interventional Group (Wash/Shampoo and Lotion)	Baby Wash/Shampoo	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.
Control Group	Daily Activities	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.

Primary Outcome Measures

Name	Time	Method
Bedtime Routine Acceptability and Feasibility to Caregivers	At 6 months	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.

Trial Locations

Locations (1)

SGS North America, Inc.; 🇺🇸 Richardson, Texas, United States