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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | 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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| Interventional Group (Wash/Shampoo and Lotion) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baby Wash/Shampoo | Other | Marketed baby wash/shampoo to be used as needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Infant:
Caregiver:
Exclusion Criteria:
Caregiver and infant:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Rodgers, Ph.D. | SGS North America, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS North America, Inc. | Richardson | Texas | 75081 | United States |
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.
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| ID | Term |
|---|---|
| D000203 | Activities of Daily Living |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Daily Activities | Other | Participants to follow their typical daily activities with their baby. |
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| Body Lotion | Other | Marketed body lotion to be used as needed. |
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| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |