May 19, 2009 Finger Lakes Region Perinatal Forum Meeting Andrea Scheurer MD

1. Delivery Room Triage of Infants of Medication Dependant Diabetic Mothers: Validation of a Risk Score for Hypoglycemia May 19, 2009 Finger Lakes Region Perinatal Forum Meeting Andrea Scheurer MD

2. Disclosures • This research was funded in part by the Finger Lakes Region Perinatal Forum Mini-Grant Program.

3. What we know Increased risk for hypoglycemia. May have hypoglycemia but be symptom free. Frequent determination of blood glucose level is necessary. What we don’t know Which infants will actually develop hypoglycemia. Which infants will need IV therapy. Best place to admit these infants. Different protocols in different hospitals. Infants of Diabetic Mothers

4. Previous Protocol at Strong/Highland TransfertoNBN Remain asymptomatic Develop symptoms or need IV glucose Stay in NICU/SCN Admit to NICU or SCN IMDDM IMDDM: Infant of Medication Dependant Diabetic Mother (Medication = insulin, glyburide, or other oral hypoglycemic)

5. Infants of Diabetic MothersImplications of the Previous Protocol • Separation of mothers and infant. • Impacts breastfeeding initiatives * • Interferes with initiation of breastfeeding within 1 hour of birth • Delays rooming-in 24 hours a day • Makes breastfeeding on demand a challenge • Impacts mother-infant bonding • Increased monetary cost * Steps 4,7,and 8 of Ten Steps To Successful Breastfeeding, The Academy of Breastfeeding Medicine, Protocol # 7

6. Background • Haidar-Ahmad developed and tested a 4-component hypoglycemic risk score in IMDDM. • Risk score helped predict which IMDDM were at risk for development of hypoglycemia requiring IV dextrose.

7. Objective • To validate this hypoglycemia risk score in a population of IMDDM at a level I community hospital.

8. Design/Methods • Eligible infants were IMDDM (insulin or glyburide). • 35 wks and without other indications for SCN care. • Risk score components were collected retrospectively. • 1 point • Maternal age ≥ 35 yrs (AMA). • Maternal blood glucose before delivery ≥120mg/dl (MBG). • Infant size for dates (LGA/SGA). • 2 points • Infant delivery room blood glucose <40 or ≥120mg/dl (DRBG). • Total risk score was calculated • 0 to 5 point total.

9. Design/Methods • Primary outcome was hypoglycemia requiring IV dextrose. • The total risk score for each infant was calculated. • The infants were divided into 2 groups: • Low risk • Risk score of ≤ 1. • High risk • Risk score of ≥ 2.

10. Design/Methods • The score was considered valid if an infant with a low risk score was at least 90% likely NOT to develop hypoglycemia requiring IV dextrose. • (95% CI of NPV 0.9-1.0). • To achieve this with α = 0.05 and power = 0.8, a sample size of 71 patients was required.

11. Results

12. Results

13. Conclusion • Conclusion • Validated a 4-component risk score as a strong and reliable predictor of hypoglycemia requiring IV dextrose among IMDDM at SMH and HH.

14. Outcome • Change in clinical practice • The risk score was implemented at SMH and HH to triage IMDDMs from delivery room to appropriate level of care for glucose monitoring. • A blood glucose monitoring protocol was followed for all infants regardless of admit location.

15. Is this infant symptomatic or <35 weeks? Is this an infant of a diabetic mother? No No Birth Center/NBN Routine Newborn Care Yes Yes Was mother taking insulin or an oral hypoglycemic agent* during pregnancy? Birth Center/NBN Newborn of Diabetic Mother Protocol No Admit to NICU *Glyburide, Metformin, or other Yes Assign Risk Score **If maternal BG unknown use total score of remaining components Total Score 0 to 1 Birth Center/NBN Newborn of Diabetic Mother Protocol Total Score 2 to 5 Admit to NICU

16. Hypothesis # 2 • By keeping low risk infants with their mothers after birth we hope to improve maternal-infant bonding, early breastfeeding success, and overall maternal satisfaction.

17. Time to First Breast-Feed

18. Thank you!

19. Goal • Examine the impact of the change in practice on breastfeeding initiation/success and maternal satisfaction with hospital course.

20. Design/Methods • Population • Strong and Highland Hospital • Postpartum women with babies born at ≥ 35 weeks • Written survey of 300 mothers • Total of 60 medication dependant diabetics (30/30) • Total of 120 healthy mothers whose infants stayed on birth center (60/60) • Total of 120 mothers whose infants went to NICU/SCN for asymptomatic chorio (60/60)

21. Design/Methods • Primary Outcome • Mothers with diabetes • Increased maternal satisfaction with their hospital course during the first day of their infants life. • Increase on average by 0.5 points (1-10). • Additional Anticipated Results • Earlier initiation of breastfeeding and improved maternal-infant bonding in the first day of life.

22. Design/Methods • Statistics • Stata 10 Effect Size Table ( 0.05, power 0.8) • Mean satisfaction score of 2 groups: 7 vs. 7.5 with SD 1 for both groups • 63 surveys per group

23. Data Analysis • Comparison of mean satisfaction scores • Student’s t test will be used for pair-wise comparisons of the group means • Analysis of variance (ANOVA) will be used for comparison of means of all three groups

24. Dear New Mother, • The following questions are being asked about your post-partum hospital experience and your satisfaction with your hospital stay. This information is being collected as part of a research study and all information will remain confidential. Thank you. • 1. What did you plan to feed your baby before your baby was born? Breastmilk , Formula , or Both  • 2. Did you try to breastfeed your baby during your hospital stay?  Yes  or No  • If No, please skip to question number 6. • 3. When did you first put your baby to breast?  Within the first hour after birth  Between 1 and 4 hours of age  • After 4 hours of age  • 4. Did your baby’s first attempt at breastfeeding occur as soon after birth as you hoped? Yes  or No  • If no, why not? ______________________________________ • If no, was this a source of stress for you?  Yes  or No  • 5. When did your second attempt at breasfeeding occur? Less than 4 hours after the first attempt  • More than 4 hours after the first attempt  • 6. Was your baby admitted to the Neonatal Intensive Care Unit? Yes or No  • 6a. If yes, did you expect this to happen? Yes  or No   • 6b. If yes, how long did your baby stay in the NICU? Less than 1 day  • More than 1 day  •                    6c. If yes, was the separation from your baby stressful for you? Yes or No  • 6d. If yes, did this make breastfeeding more of a challenge? Yesor No  • 7. What do you plan to feed your baby at home? Breastmilk , Formula , or Both  • 8. Using the scale below, please circle the number that describes how satisfied you were with the amount of time you were able to spend with your baby during his/her first day of life? • 1 2 3 4 5 6 7 8 9 10 • Very Dissatisfied Satisfied Very • Dissatisfied Satisfied

25. Survey Collection 105/150 70%

26. Mean Satisfaction Score:All Mothers 8.26 CI:7.6-8.8 8.34 CI: 7.6-9 Two-sample t-test, p value 0.8

27. Statistically Significant Results • Well infant mother satisfaction vs. IMDDM mother satisfaction. • Time to first breastfeed: Well vs. IMDDM

28. Mean Satisfaction Score:Well vs. IMDDM 9.1 CI: 8.7-9.6 7.1 CI: 6.2-8.0 Two sample t-test, p value 0.00

29. Satisfaction Score:IMDDM 38%

30. Satisfaction Score:Well 6.5%

31. Time to First Feed:Well vs. IMDDM p=0.00, Pearson chi2

32. Almost Statistically Significant • Trend towards statistical significance • Time to first breastfeed: HH vs. SMH

33. Time to First Breast Feed:SMH vs. HH p=0.22, Pearson chi2

34. Time to First Breastfeed:SMH vs. HH p=0.09, Pearson chi2

35. Not Statistically Significant • Mean satisfaction score in chorio vs. IMDDM. • Hospital differences in feeding plans. • Hospital differences in home feeding plans. • Hospital differences in viewing breastfeeding as a challenge if infant admitted to NICU/SCN.

36. Mean Satisfaction Score:IMDDM vs. Chorio 7.4 CI: 6.1-8.7 7.1 CI: 6.2-8.0 P value 0.6 Two Sample t-test

37. What’s to Come? • Continued tracking of score use • Incorporate HH data • September 2009 (1 year) • Currently collecting surveys • Anticipate completion by end of April 2009 • Final data analysis • Comparing surveys before and after risk score use • PAS • Retrospective study component 2009

38. Future Possibilities • Apply score to LGA infants? • Apply score for GDMA1 or Type II (no meds)?

39. Sources • Cornblath M, et al. Controversies Regarding Definition of Neonatal Hypoglycemia: Suggested Operational Thresholds. PEDIATRICS 2000; 105: 1141-45. • Brand PLP, et al. Neurodevelopmental outcome of hypoglycemia in healthy, large for gestational age, term newborns. Arch Dis Child 2005; 90: 78-81. • Plagemann A, et al. Impact of Early Neonatal Breast-feeding on Psychomotor and Neuropsychological Development in Children of Diabetic Mothers. Diabetes Care 2005; March Vol 28. • Johnson TS, et al. Fetal Growth Curves: Does Classification of Weight-for-Gestational Age Predict Risk of Hypoglycemia in the Term Newborn? J of Midwifery & Women’s Health 2006; 51: 39-44. • Riskin A, et al. Infant of a diabetic mother. UpToDate Jan 2008. • Avery, et al. Diseases of the Newborn. • McGowan, Jane. Neonatal Hypoglycemia. Neoreviews July 1999. • Cordero L, et al. Management of Infants of Diabetic Mothers. Arch Pediatr Adolesc Med 1998; 152: 249-254. • Van Howe RS, et al. Hypoglycemia in Infants of Diabetic Mothers: Experience in a Rural Hospital. Am J Perin 2006; 23: 105-110. • Yang J, et al. Fetal and Neonatal Outcomes of Diabetic Pregnancies. Obstetrics & Gynecology 2006; 108 no 3, part 1: 644-650. • Nold JL, et al. Infants of diabetic mothers. Pediatr Clinic N Am 2004; 51: 619-637. • Bertini AM, et al. Perinatal Outcomes and the use of oral hypoglycemia agents. J. Perinat. Med. 2005; 33: 519-523. • Rozance PJ, et al. Hypoglycemia in newborn infants: Features associated with adverse outcomes. Biol Neonate 2006.; 90 (2): 74-86. • Cowett, Richard. Neonatal Care of the Infant of the Diabetic Mother. NeoReviews 2002. E190 • Chan, SW. Neonatal Hypoglycemia. UpToDate Jan 2008. • Stewart DR, et al. Neonatal Small Left Colon Syndrome. Ann. Surgery December 1997.

40. Infants of Diabetic MothersPrevious Study at Strong • Haidar-Ahmad et al • January 2003-June 2005 • Retrospective study • Asymptomatic infants of medication dependant diabetic mothers (IMDDM) • ≥35 weeks • Primary Outcome • Hypoglycemia (BG< 40mg/dL) requiring intravenous dextrose

41. Infants of Diabetic MothersPrevious Study at Strong • Haidar-Ahmad et al • Data • Four statistically significant risk factors • Risk score for needing IV dextrose •  risk score  risk IV dextrose

42. Hypoglycemia Risk Score

43. Risk Score and Primary Outcome Fisher’s exact = P<0.001

44. NBN/BIRTH CENTER vs. NICU/SCN

45. During this study period 9.5% of infants born at SMH required transfer to NICU. NBN/BIRTH CENTER vs. NICU/SCN

46. If we use score = 0 to triage to the NBN: Reduce admissions to NICU by 43% PPV = 0.16 Sensitivity = 1 NPV = 1 Specificity = 0.47 If we use score = 0 or 1 to triage to the NBN: Reduce admissions to NICU from DR by 83% PPV = 0.4 Sensitivity = 0.67 NPV = 0.96 Specificity = 0.9 Risk of transfer to NICU/SCN from NBN/Birth Center is 15% IMDDM Study:Results of Haidar-Ahmad

47. Infants of Diabetic Mothers:Ongoing Research • Hypothesis #1 • A hypoglycemia risk score can be used in the delivery room to predict need for intravenous glucose in asymptomatic infants of medication dependant diabetic mothers.

48. Infants of Diabetic Mothers:Ongoing Research • Hypothesis #2 • Avoiding unnecessary separation of mother and infant after birth will change maternal satisfaction and aid in earlier establishment of breastfeeding.

49. Goals of my IMDDM study • Retrospectively apply and validate the score • Change in practice protocol for admission location of asymptomatic IMDDMs ≥ 35wks • Compare maternal satisfaction and breastfeeding success during hospital stay

50. Test Validation in a Retrospective IMDDM Cohort • Population • IMDDM ≥35 weeks and their mothers at Highland • Design • Two sided continuity corrected chi-square test of equal proportions ( 0.05, power 0.8) • 10% of infants with a risk score 0-1 will require IV dextrose • 40% infants with a risk score >1 will require IV dextrose • 71 charts to review • Primary Outcome • Hypoglycemia requiring intravenous dextrose