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ASSESSING THE IMPACT OF HOLDING FEEDINGS DURING PRBC TRANSFUSION ON THE INCIDENCE OF TRAGI Justin Ayala Delaine Winn Rachana Singh, MD, MS Robert Rothstein,

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Presentation on theme: "ASSESSING THE IMPACT OF HOLDING FEEDINGS DURING PRBC TRANSFUSION ON THE INCIDENCE OF TRAGI Justin Ayala Delaine Winn Rachana Singh, MD, MS Robert Rothstein,"— Presentation transcript:

1 ASSESSING THE IMPACT OF HOLDING FEEDINGS DURING PRBC TRANSFUSION ON THE INCIDENCE OF TRAGI Justin Ayala Delaine Winn Rachana Singh, MD, MS Robert Rothstein, MD

2 OVERVIEW  NEC Background  Previous / Future Studies  Our historical prospective chart review

3 NECROTIZING ENTEROCOLITIS (NEC)  Acute necrosis of the intestinal mucosa leading to bacterial translocation and infection of gut  Results in death of bowel tissue  Affects 7-13% of all very low birth weight (VLBW) infants 1  Incidence in US = 0.3-2.4 / 1000 births 1  Mortality rate = 10-44% 1  Treated medically (antibiotics) or surgically X-ray of an infant with NEC showing pneumatosis intestinalis

4 PREVENTING AND CARING FOR NEC  Incidence of NEC inversely proportional to gestational age (GA)  Etiology unknown – thought to be multifactorial  Known risk factors include:  Prematurity  Anemia of Prematurity (AOP)  Early and rapid advancement enteral feeds  Use of post-natal steroids  PDA and indomethacin treatment  Breast milk vs. formula feedings  Presence of umbilical catheters

5  No preventative measures known  Efforts include: - Slow feeding advancements - Promote breast milk feedings - Limit antibiotic use  Adverse long-term outcomes 5  Failure to thrive  Short Gut Syndrome (SGS)  Neurodevelopmental Disability  Intestinal stricture  Malabsorption Intestinal autopsy showing NEC and pneumatosis intestinalis (image via CDC) PREVENTING AND CARING FOR NEC

6 PREVIOUS STUDIES  Transfusion Associated Necrotizing Enterocolitis (TANEC)  2006: First study linking PRBC transfusions to NEC 2  Subsequent studies confirm relationship  NEC onset has temporal relationship with Tx  <48 hrs post Tx Of all NEC cases, 20-35% are transfusion associated 3,4

7 TRANSFUSION RELATED NEC (TANEC/TRAGI)  “TANEC/TRAGI” now an established Dx  = A sub- class of NEC seen in healthy growing preterm infants  Link between AOP and NEC also established 1  AOP = low hct = higher risk of NEC PROBLEM:  Anemia = NEC risk  Tx = NEC risk  Tx = Intervention for anemia

8 RESEARCH GAPS  How can the risk of TANEC be minimized?  Feedings may play role  Transfusion may start a cascade of inflammation by unknown mechanisms  Enteral Feedings during transfusion may cause additional stress QUESTION: Do feedings affect incidence of TANEC?

9 RESEARCH GAPS  Recent studies show incidence of NEC increases when patient is fed before, during, and after transfusions 6  Randomized control trials = ideal  Ongoing study 6 : Withhold feeds peri-transfusion: ≤2 before, 2 after, 1 during  Most NICUs lack special feeding protocol for time surrounding Tx  Difficult to analyze relationship

10 OUR STUDY  Intervention :  2011 Protocol change – withhold feeds during and 24 hrs after a PRBC transfusion  Outcomes :  Compare incidence of TRAGI before and after the intervention  Hypothesis : “PRBC transfusions may increase the occurrence of TRAGI and withholding feeds during transfusions will result in lower incidence of TRAGI”

11 OUR STUDY What’s different about our study?  Cohort size: Largest cohort (appx. 1600 pts) of any study looking at association of TANEC and withholding feeds  Time of feeds held: Longest length of time (24 hrs) holding feeds at tx initiation

12 METHODS / DATA DESCRIPTION  Cohort inclusion: All neonates admitted to NICU (2008-2013) ≤34 weeks GA = ~1600 subjects  Exclusion: Known congenital heart disease / chromosomal anomalies  Comparison groups:  Infants receiving PRBC transfusions in the pre and post intervention

13 DATA COLLECTION  Demographics: GA, BW, Gender  Clinical Data:  Mat. History  APGARs/MOD/Resuscitation  Mechanical ventilation  Feeds started/discharge (BM, Formula), TPN  Central line placement  Use of Antacid  Other risk factors: Hypotension, SGS, DIC, ROP, IVH, CLD, PDA, Cholestasis, Positive blood culture, SIP Note all transfusions (excluding transfusions ≤7 days after NEC diagnosis)

14 STATISTICAL ANALYSIS  Frequency distributions for categorical variables  Means and standard deviations for continuous data  Medians and ranges for count/ordinal data  Logistic regression to compare odds of TRAGI in both time periods

15 RESULTS - DEMOGRAPHICS VariablePrePostTotalp-value Gestational age(weeks) 31.26(3.00)31.47(3.02)31.36(3.01)0.1511 Gender (%) Males Females 49.58 48.99 52.75 44.24 51.09 46.73 0.106 Birth weight (Grams, mean & SD) 1716.81 (576.82) 1734.00 (572.70) 1724.97 (574.63) 0.5522 Mode of delivery (%) C-section Vaginal 55.89 41.62 59.82 38.09 57.76 39.94 0.272 Apgar score at 1min (median, mean, SD) 8, 6.70 (2.3) 8, 6.68 (2.35) 8, 6.69,2.32 0.8523 Apgar score at 5 mins (median, mean, SD) 9, 7.92 (1.69) 9, 8.0 (1.54) 9, 7.95 (1.62) 0.4227 Maternal history: PIH PPROM Chorioamnionitis Prenatal steroids 16.29% 20.45 3.80 53.63 14.79% 18.73 2.09 58.65 15.58% 19.63 2.99 55.83 0.408 0.382 0.044 0.063

16 RESULTS - DEMOGRAPHICS  Demographics & Maternal History data equivalent between pre/post groups  No Selection bias  Chorioamnionitis = only statistically significant difference  Higher incidence in pre- intervention group

17 RESULTS – OUTCOME VARIABLES VariablePrePostTotalp-value Diagnosis of NEC (%) 2.622.492.550.955 NEC stage (n) 1, Suspicious 2, Medical NEC 3, Surgical NEC 484 484 4 10 3 8 18 7 Dx of NEC (n)161733 Transfusion 48 hrs prior to Dx of NEC (n) 2 0 2 % TANEC12.5%0%6.1 % % TANEC cases feeding at time of Tx 100 % (n=2)N/A (n=0) Surgery for NEC (n) 134

18 RESULTS – OUTCOME VARIABLES  Overall incidence of NEC = similar (16 pre vs. 17 post)  Incidence of TANEC pre = 12.5% of all NEC cases  100% (2/2) TANEC patients also feeding at time of Tx  Incidence of TANEC post = 0% of all NEC cases  Statistically significant difference

19 RESULTS – SECONDARY OUTCOMES VariablePrePostTotalp-value SGS (n, %)3 (0.36)1 (0.13)4 (0.25) Discharge Status (%) Alive Dead 94.65 2.38 95.68 2.23 95.14 2.31 Mean age at discharge (days) 31.70 (26.69)28.10 (26.34)29.96 (26.58)0.0086 Age at death (med, mean, SD) in days 7, 13.84 (19.48)4, 16.82 (37.15)7, 15.25 (28.73) Mechanical Ventilation (Yes, %) 76.9368.9573.08<0.001 Diagnosis of CLD (%) 17.127.7212.65<0.001 Steroid use for CLD(%) 3.81.312.620.787 DX of PDA (%)13.228.77 11.09 0.003 Dx of DIC (%)4.523.534.050.285 Dx of IVH (%)19.8610.4715.39<0.001 Dx of ROP (%)3.802.623.240.303 Dx of Cholestasis (%) 4.884.064.490.391

20 RESULTS – SECONDARY OUTCOMES  Between post and pre groups:  Statistically significant decrease in incidence of CLD, PDA, IVH  Statistically significant decrease in mean discharge age and mean length of use of mechanical ventilation

21 CONCLUSIONS  No patient admitted to NICU developed TANEC from 2011-2013  12.5% (2 of 16) of NEC patients (2008-10) were actually of the subset TANEC  Both patients were feeding at time of tx (feeds were not held)  0% (0 of 17) of NEC patients (2011-13) belonged to this subset This preliminary analysis suggests likely association between withholding feeds during/after tx and low incidence of TANEC

22 LIMITATIONS  Preliminary data

23 APPRECIATIONS  Summer Student Scholars Program  Rachana Singh, MD, MS  Robert Rothstein, MD  Krishna Vemuri, MD  Paul Visintainer, Ph.D.  Alexander Knee, MS  NICU staff

24 REFERENCES  1 Singh R, Visintainer PF, Frantz III ID, Shah BL, Meyer KM, Favila SA, et al. Association of necrotizing enterocolitis with anemia and packed red blood cell transfusions inpreterm infants. J Perinatol 2011;31:176–82.  2 Mally P, Golombek SG, Mishra R, La Gamma EF, Nigam S, Mohandas K et al. “Association of necrotizing enterocolitis with elective packed red blood cell transfusions in premature neonates. Am J Perinatol 2006; 23(8): 451–458.”  3 Christensen RD, Wiedmeier SE, Baer VL, Henry E, Gerday E, Lambert DK et al. Antecedents of bell stage III necrotizing enterocolitis. J Perinatol 2010; 30: 54– 57.  4 Christensen RD, Wiedmeier SE, Baer VL, Henry E, Gerday E, Lambert DK et al. Antecedents of bell stage III necrotizing enterocolitis. J Perinatol 2010; 30: 54– 57.  5  5 Springer, Shelley C. "Necrotizing Enterocolitis." Necrotizing Enterocolitis. N.p., 23 Apr. 2014. Web. 09 July 2014..  6  6 "Withholding Feeds During Red Blood Cell Transfusion and TRAGI (Tx-TRAGI)." Withholding Feeds During Red Blood Cell Transfusion and TRAGI. Zekai Tahir Burak Maternity and Teaching Hospital, 17 Apr. 2014. Web. 09 July 2014..

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