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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD072821-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician anticipatory guidance about safe sleep and identify physician, patient and parent characteristics associated with coverage of the topic at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies (BHB)'s safe sleep campaign messages and services among our study participants.
This intervention trial uses a randomized controlled design and will be conducted in the Harriet Lane Clinic. The study conditions are: Standard Care Group (SG), Attention-Matched Control Group that receives a scald burn prevention intervention (CG), and Intervention Group that receives a safe sleep intervention (IG). Parents or legal guardians will be enrolled during the newborn visit (when the baby is approximately 4-7 days old). While waiting to be seen for their 2-week well-child visit, the parent will complete the Baseline Interview and be randomized to SG, IG, or CG. All participants will receive Standard of Care during all of their well-child visits, which will include standard anticipatory guidance delivered by the pediatric resident. The IG and CG interventions will be delivered in the clinic during the 2-week visit after the baseline survey has been completed. The first follow-up will be conducted at the home of the parent after completing the 2-week visit, when the baby is approximately 3-6 weeks old. The second follow-up will be conducted at the home of the parent after the 2-month well-child visit, when the child is approximately 2-4 months of age. Each home visit consists of an interview covering safe sleep and scald topics, an observation of the baby's sleep environment, and testing the water temperature. The 2-week and 2-month well-child visits will be audio-recorded, and parent or legal guardians will be asked to complete a Visit Exit Checklist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Study Condition | No Intervention | The Standard of Care control group will not receive any additional services at the newborn visit. | |
| Attention-Matched Control Condition | Active Comparator | The Attention-Matched Control Condition will include the Scald Prevention Intervention. |
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| Safe Sleep Intervention Condition | Experimental | The Intervention Condition will include the Safe Sleep Intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safe Sleep Intervention | Behavioral | A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on the baby's sleep practices. Participant will also receive a free pack'n play, sleep sack, and educational resources on safe sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants | Assessed with a 125-item questionnaire. | Follow-up #1 (3-6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home | Assessed with a 45-item questionnaire. | Follow-up #1 (3-6 weeks) |
| Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Dissemination of City Health Department's Safe Sleep Campaign Messages and Services Among Participants | Assessed with a 13-item questionnaire. | Baseline survey (2 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea C Gielen, ScD, ScM | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harriet Lane Clinic | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31254631 | Derived | Burrell TD, McDonald EM, Mahoney P, Musci RJ, Shields W, Gielen A, Solomon BS. Content of Infant Safe Sleep Counseling and Maternal Reported Practices in an Urban Clinic. Acad Pediatr. 2019 Sep-Oct;19(7):801-807. doi: 10.1016/j.acap.2019.06.014. Epub 2019 Jun 26. | |
| 28939661 | Derived | McDonald EM, Davani A, Price A, Mahoney P, Shields W, Musci RJ, Solomon BS, Stuart EA, Gielen AC. Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. Inj Prev. 2019 Jun;25(3):146-151. doi: 10.1136/injuryprev-2017-042421. Epub 2017 Sep 22. |
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| ID | Term |
|---|---|
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Scald Prevention Intervention | Behavioral | A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on practices regarding scald risks in the home. Participant will also receive a bath thermometer, candy/frying thermometer, and educational resources on scald prevention. |
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Assessed with an 11-item coding sheet and transcription file. |
| 2-week well-child visit and 2-month well-child visit |
| D066088 |
| Infant Death |