Rachel Y Moon1, Fern R Hauck2, Eve R Colson3, Ann L Kellams1, Nicole L Geller4, Timothy Heeren5, Stephen M Kerr4, Emily E Drake6, Kawai Tanabe2, Mary McClain4, Michael J Corwin4. 1. Department of Pediatrics, School of Medicine, University of Virginia, Charlottesville. 2. Department of Family Medicine, School of Medicine, University of Virginia, Charlottesville. 3. Department of Pediatrics, Yale University, New Haven, Connecticut. 4. Slone Epidemiology Center, Boston University, Boston, Massachusetts. 5. Department of Biostatistics, School of Public Health, Boston University, Boston, Massachusetts. 6. Department of Family, Community, and Mental Health Systems, School of Nursing, University of Virginia, Charlottesville.
Abstract
Importance: Inadequate adherence to recommendations known to reduce the risk of sudden unexpected infant death has contributed to a slowing in the decline of these deaths. Objective: To assess the effectiveness of 2 interventions separately and combined to promote infant safe sleep practices compared with control interventions. Design, Setting, and Participants: Four-group cluster randomized clinical trial of mothers of healthy term newborns who were recruited between March 2015 and May 2016 at 16 US hospitals with more than 100 births annually. Data collection ended in October 2016. Interventions: All participants were beneficiaries of a nursing quality improvement campaign in infant safe sleep practices (intervention) or breastfeeding (control), and then received a 60-day mobile health program, in which mothers received frequent emails or text messages containing short videos with educational content about infant safe sleep practices (intervention) or breastfeeding (control) and queries about infant care practices. Main Outcomes and Measures: The primary outcome was maternal self-reported adherence to 4 infant safe sleep practices of sleep position (supine), sleep location (room sharing without bed sharing), soft bedding use (none), and pacifier use (any); data were collected by maternal survey when the infant was aged 60 to 240 days. Results: Of the 1600 mothers who were randomized to 1 of 4 groups (400 per group), 1263 completed the survey (78.9%). The mean (SD) maternal age was 28.1 years (5.8 years) and 32.8% of respondents were non-Hispanic white, 32.3% Hispanic, 27.2% non-Hispanic black, and 7.7% other race/ethnicity. The mean (SD) infant age was 11.2 weeks (4.4 weeks) and 51.2% were female. In the adjusted analyses, mothers receiving the safe sleep mobile health intervention had higher prevalence of placing their infants supine compared with mothers receiving the control mobile health intervention (89.1% vs 80.2%, respectively; adjusted risk difference, 8.9% [95% CI, 5.3%-11.7%]), room sharing without bed sharing (82.8% vs 70.4%; adjusted risk difference, 12.4% [95% CI, 9.3%-15.1%]), no soft bedding use (79.4% vs 67.6%; adjusted risk difference, 11.8% [95% CI, 8.1%-15.2%]), and any pacifier use (68.5% vs 59.8%; adjusted risk difference, 8.7% [95% CI, 3.9%-13.1%]). The independent effect of the nursing quality improvement intervention was not significant for all outcomes. Interactions between the 2 interventions were only significant for the supine sleep position. Conclusions and Relevance: Among mothers of healthy term newborns, a mobile health intervention, but not a nursing quality improvement intervention, improved adherence to infant safe sleep practices compared with control interventions. Whether widespread implementation is feasible or if it reduces sudden and unexpected infant death rates remains to be studied. Trial Registration: clinicaltrials.gov Identifier: NCT01713868.
RCT Entities:
Importance: Inadequate adherence to recommendations known to reduce the risk of sudden unexpected infantdeath has contributed to a slowing in the decline of these deaths. Objective: To assess the effectiveness of 2 interventions separately and combined to promote infant safe sleep practices compared with control interventions. Design, Setting, and Participants: Four-group cluster randomized clinical trial of mothers of healthy term newborns who were recruited between March 2015 and May 2016 at 16 US hospitals with more than 100 births annually. Data collection ended in October 2016. Interventions: All participants were beneficiaries of a nursing quality improvement campaign in infant safe sleep practices (intervention) or breastfeeding (control), and then received a 60-day mobile health program, in which mothers received frequent emails or text messages containing short videos with educational content about infant safe sleep practices (intervention) or breastfeeding (control) and queries about infant care practices. Main Outcomes and Measures: The primary outcome was maternal self-reported adherence to 4 infant safe sleep practices of sleep position (supine), sleep location (room sharing without bed sharing), soft bedding use (none), and pacifier use (any); data were collected by maternal survey when the infant was aged 60 to 240 days. Results: Of the 1600 mothers who were randomized to 1 of 4 groups (400 per group), 1263 completed the survey (78.9%). The mean (SD) maternal age was 28.1 years (5.8 years) and 32.8% of respondents were non-Hispanic white, 32.3% Hispanic, 27.2% non-Hispanic black, and 7.7% other race/ethnicity. The mean (SD) infant age was 11.2 weeks (4.4 weeks) and 51.2% were female. In the adjusted analyses, mothers receiving the safe sleep mobile health intervention had higher prevalence of placing their infants supine compared with mothers receiving the control mobile health intervention (89.1% vs 80.2%, respectively; adjusted risk difference, 8.9% [95% CI, 5.3%-11.7%]), room sharing without bed sharing (82.8% vs 70.4%; adjusted risk difference, 12.4% [95% CI, 9.3%-15.1%]), no soft bedding use (79.4% vs 67.6%; adjusted risk difference, 11.8% [95% CI, 8.1%-15.2%]), and any pacifier use (68.5% vs 59.8%; adjusted risk difference, 8.7% [95% CI, 3.9%-13.1%]). The independent effect of the nursing quality improvement intervention was not significant for all outcomes. Interactions between the 2 interventions were only significant for the supine sleep position. Conclusions and Relevance: Among mothers of healthy term newborns, a mobile health intervention, but not a nursing quality improvement intervention, improved adherence to infant safe sleep practices compared with control interventions. Whether widespread implementation is feasible or if it reduces sudden and unexpected infantdeath rates remains to be studied. Trial Registration: clinicaltrials.gov Identifier: NCT01713868.
Authors: M S Kramer; B Chalmers; E D Hodnett; Z Sevkovskaya; I Dzikovich; S Shapiro; J P Collet; I Vanilovich; I Mezen; T Ducruet; G Shishko; V Zubovich; D Mknuik; E Gluchanina; V Dombrovskiy; A Ustinovitch; T Kot; N Bogdanovich; L Ovchinikova; E Helsing Journal: JAMA Date: 2001 Jan 24-31 Impact factor: 56.272
Authors: Lauren A Smith; Nicole L Geller; Ann L Kellams; Eve R Colson; Denis V Rybin; Timothy Heeren; Michael J Corwin Journal: Acad Pediatr Date: 2016-02-04 Impact factor: 3.107
Authors: Michael J Corwin; Samuel M Lesko; Timothy Heeren; Richard M Vezina; Carl E Hunt; Frederick Mandell; Mary McClain; Allen A Mitchell Journal: Pediatrics Date: 2003-01 Impact factor: 7.124
Authors: Rachel Y Moon; Michael J Corwin; Stephen Kerr; Timothy Heeren; Eve Colson; Ann Kellams; Nicole L Geller; Emily Drake; Kawai Tanabe; Fern R Hauck Journal: Pediatrics Date: 2019-05 Impact factor: 7.124
Authors: Ann Kellams; Stephen M Kerr; Rachel Y Moon; Fern R Hauck; Timothy Heeren; Eve Colson; Margaret G Parker; Fiona Rice; Michael J Corwin Journal: Acad Pediatr Date: 2022-02-04 Impact factor: 2.993
Authors: Rachel Y Moon; Jennifer LoCasale-Crouch; Khara L P Turnbull; Eve Colson; Ann Kellams; Timothy Heeren; Stephen Kerr; Fern R Hauck; Michael J Corwin Journal: Acad Pediatr Date: 2020-03-19 Impact factor: 3.107
Authors: Eve R Colson; Paula Schaeffer; Fern R Hauck; Lauren Provini; Mary McClain; Michael J Corwin; Emily E Drake; Ann L Kellams; Nicole L Geller; Kawai Tanabe; Rachel Y Moon Journal: J Obstet Gynecol Neonatal Nurs Date: 2019-04-08
Authors: Cara B Safon; Timothy C Heeren; Stephen M Kerr; Daphney Clermont; Michael J Corwin; Eve R Colson; Rachel Y Moon; Ann L Kellams; Fern R Hauck; Margaret G Parker Journal: Breastfeed Med Date: 2021-02-04 Impact factor: 1.817
Authors: Jennifer M Bombard; Katherine Kortsmit; Lee Warner; Carrie K Shapiro-Mendoza; Shanna Cox; Charlan D Kroelinger; Sharyn E Parks; Deborah L Dee; Denise V D'Angelo; Ruben A Smith; Kim Burley; Brian Morrow; Christine K Olson; Holly B Shulman; Leslie Harrison; Carri Cottengim; Wanda D Barfield Journal: MMWR Morb Mortal Wkly Rep Date: 2018-01-12 Impact factor: 17.586