Assessing a bedtime routine for newborns

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

This study is trying to see if a bedtime routine using products like baby wash and lotion is helpful and practical for parents taking care of their newborns.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 2 Weeks and up
• Sex: All
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide (industry)
• Locations: 1 site (Richardson, Texas)
• Trial ID: NCT06318637 on ClinicalTrials.gov

What this trial studies

This study evaluates the acceptability and feasibility of implementing a bedtime routine for newborns through caregiver questionnaires. It focuses on understanding how caregivers perceive the use of specific products like baby wash, shampoo, and lotion during daily activities. The study aims to gather insights on the practicality of such routines in enhancing infant care. By involving parents as participants, the study seeks to identify potential benefits and challenges associated with establishing a consistent bedtime routine for infants.

Who should consider this trial

Good fit: Ideal candidates for this study are full-term newborns (37 weeks gestational age or more) who are either breastfed, formula-fed, or a combination of both, along with their English-speaking legal guardians.

Not a fit: Patients who have known allergies to topical skincare products or significant health conditions that may confound the study results may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective bedtime routines that promote better sleep and overall well-being for newborns.

How similar studies have performed: While this specific approach may be novel, similar studies assessing bedtime routines for infants have shown positive outcomes in enhancing sleep quality.

Eligibility criteria

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)

Where this trial is running

Richardson, Texas

• SGS North America, Inc. — Richardson, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Nancy Rodgers, Ph.D. — SGS North America, Inc.
• Study coordinator: Robert Vera

Conditions: Newborn