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Completed

NCT Number: NCT06318637

Evaluation of the Acceptability and Feasibility 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.

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Key information

Conditions

Newborn

Age range

2 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SGS North America, Inc.

Richardson, Texas, 75081, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Baby Wash/Shampoo

Other

Marketed baby wash/shampoo to be used as needed.

Daily Activities

Other

Participants to follow their typical daily activities with their baby.

Body Lotion

Other

Marketed body lotion to be used as needed.

Primary outcomes

  1. Bedtime Routine Acceptability and Feasibility to Caregivers

    Time frame: At Day 10

    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.

  2. Bedtime Routine Acceptability and Feasibility to Caregivers

    Time frame: At Day 17

    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.

  3. Bedtime Routine Acceptability and Feasibility to Caregivers

    Time frame: At 3 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.

  4. Bedtime Routine Acceptability and Feasibility to Caregivers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Industry

Registry information

Official study title

A Clinical Evaluation of the Acceptability and Feasibility to Caregivers of a Bedtime Routine for Neonates

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2024
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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