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Behavioural Intervention
Bedtime Routine for Newborns
N/A
Recruiting
Led By Nancy Rodgers, Ph.D.
Research Sponsored by Johnson & Johnson Consumer Inc. (J&JCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand if parents find it manageable and suitable to establish a bedtime routine for newborns through a questionnaire.
Who is the study for?
This clinical trial is for newborns. Specific eligibility criteria are not detailed, but typically participants would be healthy infants with caregivers willing to follow the study's routine and complete questionnaires.
What is being tested?
The trial is testing a bedtime routine that includes using body lotion, daily activities, and baby wash/shampoo on neonates. Caregivers will report their experiences through a questionnaire.
What are the potential side effects?
Since this trial involves common baby care products and routines, side effects may include skin reactions like rashes or irritation from the products used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bedtime Routine Acceptability and Feasibility to Caregivers
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional Group (Wash/Shampoo and Lotion)Experimental Treatment2 Interventions
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.
Group II: Control GroupActive Control1 Intervention
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.
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Who is running the clinical trial?
Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
54 Previous Clinical Trials
5,481 Total Patients Enrolled
1 Trials studying Newborns
82 Patients Enrolled for Newborns
Nancy Rodgers, Ph.D.Principal InvestigatorSGS North America, Inc.
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