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

NCT06318637 | Completed

• 1 other identifier: CCSSKB005432
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Newborn

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Other: Daily Activities

Interventional Group (Wash/Shampoo and Lotion)

EXPERIMENTAL

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.

Other: Baby Wash/Shampoo; Other: Body Lotion

Interventions

Baby Wash/Shampoo OTHER

Marketed baby wash/shampoo to be used as needed.

Interventional Group (Wash/Shampoo and Lotion)

Daily Activities OTHER

Participants to follow their typical daily activities with their baby.

Control Group

Body Lotion OTHER

Marketed body lotion to be used as needed.

Interventional Group (Wash/Shampoo and Lotion)

Eligibility Criteria

• Age: 2 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

SGS North America, Inc.

Richardson, Texas, 75081, United States

Location

MeSH Terms

Interventions

Activities of Daily Living

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nancy Rodgers, Ph.D.

  SGS North America, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: April 18, 2024
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)