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

Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318637
• Other study ID #: CCSSKB005432
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: December 23, 2024

Study information

• Verified date: May 2024
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: Robert Vera
• Phone: +01 972 392 1529
• Email: Robert.Vera[@]sgs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 23, 2024
• Est. primary completion date: December 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Weeks and older

Eligibility

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)

Related Conditions & MeSH terms

• Newborn

Intervention

Other:
• Baby Wash/Shampoo
Marketed baby wash/shampoo to be used as needed.
• Daily Activities
Participants to follow their typical daily activities with their baby.
• Body Lotion
Marketed body lotion to be used as needed.

Locations

Country	Name	City	State
United States	SGS North America, Inc.	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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