Design and Evaluation of a Single Family Room NICU

1. Design and Evaluation of a Single Family Room NICU Barry Lester, PhD, Mary Sullivan, PhD, Rose Bigsby,ScD, Abbot Laptook, MD, James Padbury, MD and Vera Van Middlesworth Brown Center for the Study of Children at Risk

3. Rationale Infants in the NICU are affected by environmental factors Single room NICU has potential to: • Improve outcomes • Sensitivity to developmental needs • Family involvement in care • Privacy • Staff Satisfaction

4. Rationale BUT….Urban Legend Concerns: • Infant safety • More staff • Isolation (staff and families) • Families present during procedures • Stress • Logistics Walsh et al. Advances in Neonatal Care. 2006;6:261-270 Carlson et al. Advances in Neonatal Care. 2006;6:271-280

5. How to Study? 1. RCT: Ideal or is it? Infants not representative of NICU Bias in care 2. Observational Study in Hybrid NICU Medical status of Infants in single room 3. Alternative: Observational Prospective “Before and After” Study

6. Sites Selected: • Vanderbilt University Children’s Hospital Nashville, Tennessee • Blank Children’s Hospital Des Moines, Iowa • Northside Hospital Atlanta, Georgia • Scottish Rite Children’s Hospital Atlanta, Georgia • Children’s Hospitals – St. Paul St. Paul, Minnesota Women & Infants

7. Women & Infants Existing NICU E 9,400 sq. ft. D C B A

8. Floor 2 NICU 70 rooms

10. Women & Infants Mock Up 175 sq. ft.

11. Family Center

12. Specific Aim 1 Compare the medical and neurobehavioral status at discharge of infants in an Open Bay NICU with infants in a Single Room NICU

13. Specific Aim 2 Determine the role of potentially mediating factors in explaining differences in the medical and neurobehavioral status at discharge of infants in an Open Bay NICU with infants in a Single Room NICU

14. NICU Design and Infant Outcome Open Bay vs. Single Room Infant Medical & Neurobehavioral Outcomes Family Centered Care Developmental Care Parent/Family Factors Staff Behavior/Attitudes Medical Practices

15. Medical Outcomes

16. Neurobehavioral Outcomes

17. Mediators: Family Centered Care • Cochrane Collaboration Family Centered Care Clustered Rating Scale Administered to parents and staff

18. Mediators: Developmental Care • Evaluating Your Practice According to Four Standards of Developmental Care • Sound and light • Elements of Developmental Care in NICU

20. Pilot Data

21. Mediators: Parenting Factors

22. Mediators: Staff Attitudes

23. Mediators: Changes in Medical Practice • Pulmonary • Cardiovascular • Nutrition/GI • Infectious disease • CNS measures

24. Setting: Women and Infants • Regional Perinatal Center • 10th largest obstetrical service in U.S. • 9,600 annual births • 75% births in R.I. • 1,300 in NICU (of which 175 transports) • 440<2000 grams (2004)

25. Sample Open Bay (n=880) vs Single Room (n=880) • <2000 grams • In NICU for at least 2 weeks • Nipple feeding

26. Power

27. Timeline

28. NICU Recruitment Database RECRUITMENT REPORT Summarizes recruitment and Completion data STUDY PROCEDURE COMPLETION Staff record what instruments have been collected ELIGIBILITY TRACKING Study staff add update information about recruitment status CERNER dob-birthweight-etc. • SUBJECT IDENTIFICATION • NICU Admissions with BW < 2000 grams • Demographic information for eligibility / recruitment DailyUpdate

29. Report pulls current data and summarizes for up to date tracking as needed.

30. Data Analysis • Traditional Statistics ANOVA, Logistic Regression • Advanced Statistics Structural Equation Modeling (SEM) with latent factors

31. Full Structural Equation Model

32. Family Centered Care Medical Practice Developmental Care Infant Outcome NICU Parent/ family Staff Behavior/ Attitude Structural Equation Model

33. Infant Outcome NICU β=.70 Hypothetical: NICU Main Effect

34. Family Centered Care Medical Practice Developmental Care β=.23 β=.21 β=.27 β=.19 β=.24 β=.20 Infant Outcome NICU β=.50 β=.20 β=.28 β=.22 β=.18 Parent/ family Staff Behavior/ Attitude Hypothetical: NICU Reduced Effect Comparative Fit Index >.95

35. Medical Practice Family Centered Care Developmental Care β=.33 β=.31 β=.37 β=.29 β=.34 β=.30 Infant Outcome NICU β=.N.S β=.30 β=.38 β=.32 β=.28 Parent/ family Staff Behavior/ Attitude Hypothetical: NO NICU Effect Comparative Fit Index >.95

36. Limitations • “Before-After” design • Secular changes • Generalizability • “Water” • Long term follow-up

37. Summary Single Room NICU • Major response to improving care • Face validity • Evidenced based research to determine effects (+/-) on infant, family, staff • Findings will have a substantial impact on NICU care of premature infant