Neurodevelopmental Outcomes of FICare & FICare Cases of Intubated Infants

Transcription

1 Neurodevelopmental Outcomes of FICare & FICare Cases of Intubated Infants Dr. Mingyan Hei, MD, Ph.D. Department of Pediatrics the Third Xiangya Hospital of Central South University Changsha, Hunan, PR China

2 There is no Conflicts of Interests. Adelaide, Mingyan Hei, China 2

3 China Hunan The capital city Changsha 2015, in Hunan province: Total population is 633 million (urban population 50.89%) Birth rate is Mortality rate is 6.86 Number of NICUs with bed No. > 40 is Government White Book of Economy & Social Development of Hunan Adelaide, Mingyan Hei, China 3

4 The capital city of Hunan: Changsha 2015: Birth rate: Mortality rate under 5 years old: 4.77 Mortality rate under 1 years old: 2.88 Neonatal mortality rate: Statistic Data from Department of Maternity & Child Health of Hunan Adelaide, Mingyan Hei, China 4

5 A Neurodevelopmental Study FICare Cases of Intubated Infants Adelaide, Mingyan Hei, China 5

6 A Neurodevelopmental Study Adelaide, Mingyan Hei, China 6

7 Title of Initial FICare study in China: Impact and Cost-effectiveness of the Family Integrated Care Model on the Outcomes of Stable Preterm newborns in Intensive Care Units (NICUs) in China: A Cluster Randomized Controlled Trial. (Funds: CIHR CTP87518, CMB OC ) Adelaide, Mingyan Hei, China 7

8 Inclusion Criteria 1. GA 28 weeks~35 weeks; and 2. Have been receiving enteral feeds for >24 hours; and 3. Have vital signs been stable for >24 hours. Adelaide, Mingyan Hei, China 8

9 Exclusion Criteria 1. Require either invasive or noninvasive ventilation support; 2. Require surgical intervention(s); 3. Are receiving palliative care; 4. Are likely to be discharged within 1wk; 5. Weigh less than 400 g at birth; 6. Parents have language barrier; and/or 7. Parents do not sign the consent form. Adelaide, Mingyan Hei, China 9

10 Adelaide, Mingyan Hei, China 10

11 Adelaide, Mingyan Hei, China 11

12 Adelaide, Mingyan Hei, China 12

13 Both Moms and Babies are doing great! Adelaide, Mingyan Hei, China 13

14 Working hours (upper) and Limited visiting hours (lower) in most NICUs in China Adelaide, Mingyan Hei, China 14

15 Let parents stay in the NICU and integrate them into the team. Adelaide, Mingyan Hei, China 15

16 NBNA CGA 37wk FICare Control Fig 1. NBNA CGA 37wk Adelaide, Mingyan Hei, China 16

17 Peri- FICare studies and funds RMB 100,000 To expand centers from 6 to 10. CCNCRP (2014/2015/2016) RMB 60,000 To do of age. CMB OC USD 135,000 CIHR CTR87518 (2014) RMB 60,000 To do aeeg study. CAD 20,000 Infant-care Team. Adelaide, Mingyan Hei, China 17

18 Human neurodevelopment is closely related to the maturity of brain, which happens in the last 4~6 weeks of the gestation. -- Bhutta AT et al. JAMA, 2002, 288 (6): Zacharia A et al. AJNR, 2006, 27 (5): Kinney HC et al. Semin Perinatol, 2006, 30 (2): Adelaide, Mingyan Hei, China 18

19 The objective of this study was to understand the neurodevelopment of FICare infants at 18M of age. Adelaide, Mingyan Hei, China 19

20 Methods A prospective parallel case-control study. Study period: July 2015 ~July Venue: Department of Child Healthcare in the Third Xiangya Hospital of Central South University. Adelaide, Mingyan Hei, China 20

21 FICare group: preterm infants enrolled in previous FICare study with gestational age (GA) 28-35wks. Control group: preterm infants matched with gender, birth weight (BW), BW percentile and days of life (DOL) at followup (1:1 ratio) who did not enter FICare in NICU. Adelaide, Mingyan Hei, China 21

22 No. of FICare infants met inclusion criteria, n = 100 Excluded No. of infants, n= 33 Parents refuge to sing on the consent, n = 14 Died before 18M of age, n = 0 Hospitalization within 2 weeks before 18M of age, n = 4 Expected not to be discharged from hospital within 2 weeks at 18M of age, n = 2 Lost of contact with the paretns, n = 11 Delayed BSID for more than 2 weeks d/t unknown reasons, n = 2 No. of FICare infants enrolled n = 67 Non FICare infants matched with gender, birth weight (BW), BW percentile and days of life (DOL) at follow-up (1:1 ratio) Final sample size n=134 (n=67 in each of FICare and Control group) Figure 1. Protocol of patient enrollment Adelaide, Mingyan Hei, China 22

23 Parameters: Demographic data: GA, BW, gender, etc. Family and parent background: Maternal education year Socioeconomic Status (SES), by Graffar method Home Observation for Measurement of the Environment (HOME) Mental Development Index (MDI) and Psychomotor Development Index (PDI) by Bayley Scales of Infant Development (BSID). Adelaide, Mingyan Hei, China 23

24 Statistical Analysis SPSS 20.0 chi-square test, t test, Pearson coefficient test and Spearman coefficient Adelaide, Mingyan Hei, China 24

25 FICare (n=67) Control (n=67) Χ 2 /t Male, n(%) 35(52) 34(51) GA, wk BW, g SGA, n (%) 5(8) 6(9) Apgar<7@5min, n(%) 2 (3) 1 (2) C/S born, n(%) 27(40) 29(43) PPROM> 18h, n(%) 28(42) 18(26) RDS 38(57) 33(49) Suspected/ Sepsis 34(51) 29(43) Asphyxia 14(21) 11(16) Hypoglycemia 11(16) 13(19) Intubated >72h, n(%) 9(13) 8(12) NCPAP>1wk, n(%) 8(12) 9(13) Table 1. Demographic & Clinical Data Adelaide, Mingyan Hei, China 25 P

26 FICare (n=67) Control (n=67) Χ 2 /t P Maternal Dis Hypertension 11(16) 12(18) GDM 4(6) 7(10) Thyroid Dis 2(3) 4(6) Maternal Education Yr, yr SES HOME Table 2. Maternal & Family Data Adelaide, Mingyan Hei, China 26

27 FICare Control (n=67) (n=67) Χ 2 /t P BSID, d BSID, kg MDI PDI Table 3. MDI & PDI at 18M of age Adelaide, Mingyan Hei, China 27

28 GA n MDI MDI FICare Control df PDI FICare Control PDI 28~ ~ ~ ~ ~ ~ ~ Table 4 MDI & PDI difference between 2 groups The MDI and PDI of all groups were positively related to GA (r=0.398, P= r=0.272, P=0.001), but the difference between 2 groups was not related to GA (r=0.679, P=0.094; r=-0.393, P=0.383). Adelaide, Mingyan Hei, China 28 df

29 Baby FuYi, GA 33wk6d, BW 1730g. Now 2yr5m old. Her Mom had hysterectomy d/t HPT. Adelaide, Mingyan Hei, China 29

30 Baby GeeGee, GA 30wk1d, BW 1010g. SGA. Now 2yr 4mon. Very naughty, active & talkative. Baby TingTing, GA 29wk1d, BW 1100g. Had huge feeding problems + apnea + corpus callosum displasia. Now 2yr 4mon. Healthy and happy. Adelaide, Mingyan Hei, China 30

31 About BSID It fits for infants between 2~30M of age. Totally 244 items (81 items for MDI, 163 for PDI). The 1 st choice for assessing the pre- and post-development of infants. -- Bayley N. Child Dev., 1965, 36: Rose O et al. Pediatrics, 2016, 131(5): e Adelaide, Mingyan Hei, China 31

32 Control infants were matched with FICare infants only by GA, BW, and BW-GA percentile. Not by disease. -- Variation issue. To do hierarchy (subgrouping). The difference between 2 groups was not related to GA, indicating that we cannot say The smaller the infants, the better effect the FICare. Adelaide, Mingyan Hei, China 32

33 Why not cluster randomization Loss of follow-up! FICare Control Site % 12.3% Site % <5% Site 3 <5% <5% Site % 21.6% Site 5 <5% (late joined in) Site 6 (late joined in) / Table 5. Followup rate in each center at 18M Adelaide, Mingyan Hei, China 33

34 Reasons for the lose of follow-up Parents did not agree to sign the consent. Infants were in hospitalization within 2 weeks peri-18m of age. Loss of contact with the parents. Parents considered it to be too troublesome to go to the hospital for followup (currently living in other cities). Parents consider their infants very good and just did not want to go for the follow-up. Adelaide, Mingyan Hei, China 34

35 City F/U F/U Method Rate of F/U Ref & year Shenzhen 18M & 24M Phone call Beijing 18M Community & Home visit 81.5% & 49.2% 66.7% & 83.1% Wei Z et al Zhou WJ et al, 2013 Shanghai 18M Home visit 75.2% Ma JQ Wei Z et al. Chin J Child Healthcare, 2012, 20 (4): Zhou WJ et al. J Beijing Univ. (Med), 2013, 45(2): Ma JQ. J Shanghai Community Univ., 2015 Adelaide, Mingyan Hei, China 35

36 About the SES & HOME in this study FICare (n=67) Control (n=67) Χ 2 /t P SES HOME The family is at middle-upper level of Chinese society. HOME indicates generally stable and typical family structures in China. Adelaide, Mingyan Hei, China 36

37 About SES by Graffar method Total score: 45 Parameters: No. of family members, parent marriage status, the highest education degree of parents, parents employment status, self-own house or rental house, house area, running water status, rental or self-own furniture, self-assessment of crowdness of the house. The average SES in China is ~ Bradley RH et al. Annu Rev Psychol, 2002, 53: Shu M. City, 2008, 155(6): Chen W et al. J Demographics, 2012, 32(16): 3-8 Adelaide, Mingyan Hei, China 37

38 Total score: 65 About HOME score For assessing the influence of mood, social activity, behavior of parents to the infants. Parameters: 45 items in 5 regimens (parental responsibility, parents selfregulation, house tidiness and maintenance, family study atmosphere, diversity of parent s knowledge. The HOME in China is 30~ Crosnoe R et al. Child Dev, 2010, 81(3): Bradley RH et al. Annu Rev Psychol, 2002, 53: Chen W et al. J Demographics, 2012, 32(16): Zhang SW et al. J Demographics, 2008, 28 (3): Adelaide, Mingyan Hei, China 38

39 Neurodevelopmental outcomes at 18M of age for FICare infants is quite positive! Adelaide, Mingyan Hei, China 39

40 FICare Cases of Intubated Infants Adelaide, Mingyan Hei, China 40

41 1. Venue: Preterm NCIU of Hunan Children s Hospital (Director is Dr. Xirong Gao, Chief nurse is Ms Yue-E Xiong) Dr. Xirong Gao 2. Total No. of FICare cases: 141 (1) Enrolled in the previous multicenter RCT trail: 47 (2) Further excluded: 28 (21 with GA <28wk, and 7 with GA > 35wk) (3) Extension of FICare: 21 intubated infants and 45 NCPAP infants. Ms. Yue-E Xiong Adelaide, Mingyan Hei, China 41

42 Case 1 1. ID , male, GA:27 +1 w,bw:900g 2. C/S born in a municipal hospital with Apgar 1-8,5-9, and transferred on DOL06 3. Discharge Diagnosis: 1. ELBWI (GA27 +1 wks) 2. NRDS 3. BPD 4. ROP (stage II) 5. Sepsis (clinical diagnosis) 6. Anemia of Prematurity Adelaide, Mingyan Hei, China 42

43 Respiratory support (for 143 days): - SIMV(65 days) - HFOV(4 days) - NIPPV(21 days) - ncpap(10 days) - Nasal catheter oxygen(43 days) Adelaide, Mingyan Hei, China 43

44 Started FICare on DOL60 (on SIMV) & total FICare 95d; Discharge wt 4660g & 80ml q3h (137ml/lg/d) Adelaide, Mingyan Hei, China 44

45 Case 2 1. ID , M, GA 24w3d,BW 1100g,Apgar 1-3,5-6, Transferred on DOL 21d 3. Discharge Diagnosis : 1. ELBWI (GA wks ) 2. Severe BPD 3. Neonatal sepsis(candida infection) 4. ROP(stage III) 5. Congenital heart disease(vsd,pfo) 6. Anemia of Prematurity Adelaide, Mingyan Hei, China 45

46 Respiratory support (Totally for 131 days): - SIMV (39 days) - HFOV (22 days) - NIPPV (12 days) - ncpap (30 days) - NC O2 (28 days) Adelaide, Mingyan Hei, China 46

47 Start FICare on DOL 66 (on NIPPV), & totally FICare for 110days. Discharged on DOL155 with Wt 4900g & 83ml Q3h (TFI 135.5ml/kg/d) Adelaide, Mingyan Hei, China 47

48 Other Cases (1) Adelaide, Mingyan Hei, China 48

49 Other Cases (2) Adelaide, Mingyan Hei, China 49

50 Happy discharge home! Adelaide, Mingyan Hei, China 50

51 Take home messages Adelaide, Mingyan Hei, China 51

52 FICare in NICU is beneficial to the development of preterm infants at 18M of age. Further follow-up study should be continued as at 24M, 3yr, 6yr, and older age. But the loss of follow-up might be a big issue. Mechanisms of positive neuroprotective effect of FICare to preterm infants should be carried on. FICare for intubated infants is feasible, but more study should be futher completed. Adelaide, Mingyan Hei, China 52

53 Acknowledgements Grants: Canada Institute of Health Research (CTP87518) & Chinese Medical Board (CMB OC ) Policy support from the Third Xiangya Hospital of Central South University. Pediatricians and nurses in each joint NICU. Colleagues in MSH. Adelaide, Mingyan Hei, China 53

54 Doctors and nurses in the Third Xiangya Hospital of Central South University. Doctors and nurses in the Preterm NICU of Hunan Children s Hospital. Adelaide, Mingyan Hei, China 54

55 Welcome to Changsha, China Adelaide, Mingyan Hei, China 55

56 Thank you for your attention! Adelaide, Mingyan Hei, China 56