Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Sudden Infant Death Syndrome Clinical Trial

Official title: Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Infant Death
• Sudden Infant Death
• Sudden Infant Death Syndrome

• NCT number: NCT03070639
• Study type: Interventional
• Source: Johns Hopkins Bloomberg School of Public Health
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Completion date: June 2017