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

September 23, 2025 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Richardson, Texas, United States, 75081
        • SGS North America, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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
Participants to follow their typical daily activities with their baby.
Experimental: Interventional Group (Wash/Shampoo and 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.
Other: Baby Wash/Shampoo
Marketed baby wash/shampoo to be used as needed.
Other: Body Lotion
Marketed body lotion to be used as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At Day 10
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.
At Day 17
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.
At 3 months
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.
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

  • Principal Investigator: Nancy Rodgers, Ph.D., SGS North America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2024

Primary Completion (Actual)

August 12, 2025

Study Completion (Actual)

August 12, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCSSKB005432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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