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Pediatric Renal Trials and Collaborative Studies Special Analysis William A. Carey, Lynya I. Talley, Sally A. Sehring, Janet M. Jaskula and Robert S. Mathias Pediatrics 2007;119;e468-e473; originally published online Jan 15, 2007; DOI: 10.1542/peds.2006-1754
The online version of this article, along with updated information and services, is located on the World Wide Web at: http://www.pediatrics.org/cgi/content/full/119/2/e468
PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2007 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
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We sought to determine the outcomes of initiating long-term dialysis of neonates and children aged Ͼ1 to 24 months with end-stage renal disease. E-mail: william. CA 94118-1245. University of California.ARTICLE Outcomes of Dialysis Initiated During the Neonatal Period for Treatment of End-Stage Renal Disease: A North American Pediatric Renal Trials and Collaborative Studies Special Analysis William A.edu PEDIATRICS (ISSN Numbers: Print.2006-1754 doi:10. their overall risk of mortality was similar to that observed in older children. Carey. 2006 Address correspondence to William A. Mathias. Rates of renal transplantation were signiﬁcantly lower in the neonates compared with the older children.carey@ucsf. RESULTS. Multivariate analyses were performed using Cox proportional hazards models.pediatrics. and duration of hospitalization was compared using the Wilcoxon 2-sample test. California. Moreover.2006-1754 Key Words neonate. Although neonates were more often hospitalized. 1098-4275). By querying the North American Pediatric Renal Trials and www. but neonates were more likely to recover function of the native kidney. survival Abbreviations ESRD— end-stage renal disease NAPRTCS—North American Pediatric Renal Trials and Collaborative Studies ARPKD—autosomal recessive polycystic kidney disease CNS— congenital nephrotic syndrome CI— conﬁdence interval Accepted for publication Aug 14. Sehring. University of California San Francisco. Maryland The authors have indicated they have no ﬁnancial relationships relevant to this article to disclose.org/cgi/doi/10. 2010 . Lynya I. Neonates with end-stage renal disease were more likely to receive perito- neal dialysis versus hemodialysis than older children with end-stage renal disease. Neonates with a presumptive diagnosis of end-stage renal disease may initiate long-term dialysis during the ﬁrst month of life with outcomes comparable to those of patients who initiate dialysis later in infancy. Copyright © 2007 by the American Academy of Pediatrics Collaborative Studies database. Product limit methods were implemented. Rockville. Janet M. we obtained information on 193 neonates (Յ1 month of age) and 505 children (Ͼ1–24 months of age) with a presumptive diagnosis of end-stage renal disease who initiated long-term dialysis. 3333 California St. bEMMES Corporation. end-stage renal disease. University of California San Francisco Children’s Hospital. e468 CAREY et al Downloaded from www. Suite 150K.1542/ peds. CONCLUSIONS. neonates who initiated dialysis during the ﬁrst month of life were just as likely to terminate dialysis as were the older children. 0031-4005. renal transplantation. Online. dialysis. UCSF Children’s Hospital. Carey. RNc.1542/peds. ABSTRACT OBJECTIVE.org. and the log rank test was used to compare time-to-event analyses. Division of Neonatal-Perinatal Medicine. MDa. MDa. Jaskula. San Francisco. Robert S.pediatrics. PATIENTS AND METHODS. PhDb. Sally A. MDc Divisions of aNeonatal-Perinatal Medicine and cPediatric Nephrology. San Francisco. Provided by Indonesia:AAP Sponsored on May 7. MD. Talley. Dialysis characteristics and likelihood of hospitalization were compared using the 2 test.
2 Morbidities and mortality related to the disease and its treatment are common.13 Likewise. patient mortality. the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) has maintained a voluntary dialysis registry database that includes information on thousands of pediatric patients requiring long-term dialysis. time to transplant.1. we compared neonates who initiated longterm dialysis during the calendar years 1992–1998 (past) with those who had initiated during the calendar years 1999 –2005 (recent). Thus.05. likelihood of and reason for termination of dialysis.15 For this study.1. race. each center following the requirements of its PEDIATRICS Volume 119. or other (eg. modality changes. change of medical center. PATIENTS AND METHODS Since January 1. Speciﬁcally. To describe the outcomes of children with ESRD who initiated long-term dialysis during the neonatal period. peritonitis. and time to death were performed. The reasons for termination of dialysis included renal transplant. providing care to a chronically ill child can be overwhelming. Provided by Indonesia:AAP Sponsored on May 7. In all. neonates were subcategorized on the basis of the date on which dialysis was initiated. For survival analyses. dialysis characteristics. death. and likelihood and duration of hospitalization. nearly all who responded would offer treatment to some neonates with ESRD. 2010 . 1992. irrespective of whether transplantation.pediatrics. Dialysis modalities were characterized as peritoneal dialysis or hemodialysis. primary renal diagnosis and type of dialysis at the time of initiation. Plots depicting time to transplant and time to death were created using Kaplan-Meier methods.9–12 Because of these limitations. death) were censored at the last date of contact or at the date of termination or death. change of dialysis modality. Number 2. often spanning birth to 24 months. congenital nephrotic syndrome (CNS). and hospitalization were compared using the 2 test.4 and the growth and development of surviving infants are often suboptimal. patients were categorized on the basis of age as neonates (Յ1 month) or older children (Ͼ1–24 months).5 This scarcity of published data also may account for the variability of attitudes displayed by those who provide primary and specialty care for neonates with ESRD. we analyzed data regarding patient gender and race. whereas others would be willing to treat their patients through transplantation. Product limit analyses of termination. type of dialysis. February 2007 e469 Downloaded from www. we queried the NAPRTCS database to obtain information about children who initiated long-term dialysis for treatment of ESRD within the ﬁrst 24 months of life during the calendar years 1992 to 2005.8 there are limited data regarding the outcomes of initiating long-term dialysis for treatment of ESRD during the ﬁrst month of life. we conducted the following study to determine the frequency of key outcomes of initiating long-term dialysis for treatment of presumptive ESRD during the ﬁrst month of life. To determine whether outcomes had improved over time for neonates with ESRD who initiated dialysis during the ﬁrst month of life. pancreatitis. Patient characteristics. to the diverse etiologies of neonatal ESRD and to the small numbers of patients who are available for analysis. but its implications for the patients and their families are substantial. termination characteristics. and center size. overall mortality. To categorize centers based on size. and data were compared using the log rank test. This lack of information is attributable. Although dialysis has been used to treat neonatal renal failure for decades. and other.4. Confounding factors taken into consideration include: gender. time to transplantation.3. Multivariate analyses were performed using Cox proportional hazards models. the total number of subjects enrolled in the NAPRTCS registry was computed for each center and then summed. Speciﬁcally. whereas those that had enrolled Յ40 were categorized as small. “time to transplant” was deﬁned as the interval from the date of the ﬁrst registryreported initiation of dialysis until the date of transplant. in terms of both emotional and capital resources.5–7 For families. obstructive uropa- E ND-STAGE RENAL DISEASE (ESRD) occurs infre- thy. time to death was deﬁned as the interval from the date of the ﬁrst registry-reported initiation of dialysis until the date of death.14 To provide further insight into this complex issue. All of the tests of signiﬁcance were 2-sided with ␣ at . the decision to initiate longterm dialysis in neonates with a presumptive diagnosis of ESRD is complex and may present an ethical dilemma for physicians and family members alike. In a worldwide survey of pediatric nephrologists. whereas less than half would offer such treatment for all neonates.org.quently during the ﬁrst month of life. For analyses involving time to transplant. 98 centers contributed data that were analyzed in this study. autosomal recessive polycystic kidney disease (ARPKD). Duration of hospitalization was compared using the Wilcoxon 2-sample test. centers that had enrolled Ͼ40 patients were categorized as large. recovery of native kidney function. and family choice). For analysis purposes. the neonatal dialysis experience has been lost in studies that describe the outcomes of infants of a broader age range. The median value was chosen as the cut point. or recovery of native kidney function had occurred. many neonatologists consider “unfavorable” the prospect of initiating dialysis as a bridge to renal transplant for their patients. primary renal diagnosis. Primary renal diagnoses were entered in the database as renal a-/hypo-/dysplasia (dysplasia). Those patients who were still on the initial dialysis at the last date of contact or those who terminated dialysis for a reason other than transplantation (eg. in part.
Log rank test.659a 157 (81.5) 24 (12.02.6) 129 (66.4) is by 2 test. Provided by Indonesia:AAP Sponsored on May 7. the reason for terminating dialysis differed signiﬁcantly between the 2 age groups (P Ͻ . After adjusting for confounding factors.5) is by 2 test.045 cases of dialysis-treated neonatal ESRD per million population per year. children have a relative hazard of termination because of transplantation that is 1.17 NAPRTCS reported an incidence of 0.2) P . n (%) Renal transplant Change of modality Death Recovery of native kidney Other aP Ͼ1–24 mo (n ϭ 505) 418 (82. and they were less likely to terminate because of transplantation. whereas 26 (15%) e470 CAREY et al Downloaded from www.4) 28 (5.8) 87 (17.pediatrics.3) 36 (18. On the other hand.2) 176 (34.19 –2.32 cases per 100 000 live births.16. there also was a signiﬁcant difference in the time to transplant between the 2 age groups. Table 4). RESULTS NAPRTCS data were available for 193 patients who initiated long-term dialysis during the ﬁrst month of life and for 505 patients who initiated between Ͼ1 and 24 months of age.192).1) Ͻ.8) 28 (14.8) 40 (7.0) 189 (97. neonates were more likely to recover native kidney function. the median follow-up times were 17. TABLE 3 Termination Characteristics of Those Infants Who Initiated Dialysis at Age <1 Month or >1–24 Months Յ1 mo (n ϭ 193) Terminated.2) .55 times that of neonates (95% conﬁdence interval [CI]: 1.4) 17 (10.19 NAPRTCS reported an incidence of 0. Table 2 details the distribution of primary renal diagnoses and the type of dialysis of each age group. the percentage of neonates receiving transplantation more closely approximated that of the older children within 3 years of the initiation of dialysis. Given the mean populations of the United States and Canada during the study period.0) P Ͻ. For survival analyses. Over the 5 years after initiation of dialysis.18. Neonates were more likely to be diagnosed with renal dysplasia or ARPKD. Seventeen (9%) neonates died during their initial dialysis course. n (%) Male Female Race. As shown in Fig 1.5) 89 (15.7) 48 (9.001).3) 39 (20. n (%) White Black Hispanic Other aP FIGURE 1 Time to transplant: neonates versus older children.001). Given the mean number of annual live births in the United States and Canada during the ﬁrst 12 years of the study period. n (%) Renal dysplasia Obstructive uropathy ARPKD CNS Other Type of dialysis.0) is by 2 test.9) 3 (1. Nearly all of the neonates were treated with peritoneal dialysis (98%). Overall.7) 73 (46. and they were less likely to require a change in the type of dialysis.8) 23 (14.324a 306 (60. neonates were as likely to terminate dialysis during the study period as were older children (81% vs 83%). Neonates were more likely to terminate because of death. The gender and race characteristics of the neonates were similar to those of the older children (Table 1).4) 12 (6. whereas older children were much more likely to suffer from CNS (P Ͻ . However. P Ͻ . As shown in Table 3.001a 457 (90.001a 241 (57.7) 202 (40.9) 4 (2. 46 (24%) of 193 neonates and 100 (20%) of 505 older children expired during the study period (P ϭ .5) 56 (29.418a 132 (68.001.7) 81 (19.001a 72 (37. whereas 9% of older children received hemodialysis (P Ͻ .6) 23 (14.001). Ͼ1–24 mo (n ϭ 505) 329 (65.5) 83 (16. n (%) Yes No Reason terminated. 2010 .4) 88 (17. n (%) Peritoneal dialysis Hemodialysis aP Ͼ1–24 mo (n ϭ 505) 129 (25.9) 17 (4.4) 61 (31.2) 23 (11.8) P .1) 46 (11. older children were transplanted more quickly than were neonates (P Ͻ .6 months for older children.001).4) 33 (7.org. Neonates (n ϭ 193) transitioned to renal transplantation less quickly than did older children (n ϭ 505). multivariate analysis also revealed that older TABLE 2 Dialysis Characteristics of Those Infants Who Initiated Dialysis at Age <1 Month or >1–24 Months Յ1 mo (n ϭ 193) Diagnosis.9) 54 (10.local institutional review board for participation in NAPRTCS. TABLE 1 Characteristics of Those Infants Who Initiated Dialysis at Age <1 Month or >1–24 Months Յ1 mo (n ϭ 193) Gender.6) Ͻ.8 months for neonates and 14.5) 21 (13. However.
After the initiation of dialysis.1. FIGURE 3 Time to transplant: past versus recent cohorts. However.65–1.14) 1. the vast majority of both neonates and older children required hospitalization (80% vs 73%.91) 1. As shown in Fig 2.54–0.034).15 (0.00 (0. P Ͻ . because the neonates in our study were just as likely to terminate dialysis as were older children. by 5 years postinitiation. in contrast to only 60% of the past cohort. Downloaded from www.001).88–1. after adjusting for confounding factors.01) 1.org. and Time to Death Termination HR Transplant HR (95% CI) (95% CI) Age group 1–24 vs Յ1 mo Gender Male vs female Cohort era 1992–1998 vs 1999–2005 Center size Ͼ40 vs Յ40 patients Diagnosis Dysplasia vs all others Obstruction vs all others Death HR (95% CI) 1.401). cohort era.TABLE 4 Multivariate Analyses: Time to Termination.89 (0. the decision to initiate long-term dialysis for a neonate with presumptive ESRD poses a complex ethical quandary. However.88–1.24) 1. the recent cohort of neonates tended to have better survival during the 3 years after the initiation of dialysis (P ϭ . talized.39) 0.2 This dilemma derives.pediatrics.68–0.69 (0.14. Time to Transplant.56–1. Table 4).07 (0. ϳ80% of neonates in this study had transitioned to renal transplantation. transplantation.16 (0. Log rank test. within 3 years of initiating dialysis.325 (not signiﬁcant). at least in part.77 (0. 80% of the recent cohort had undergone transplantation. and center size had no inﬂuence on the time to termination.89–1.99) 0.05) 0. Similarly.63–1. Multivariate analyses also indicated that gender.61–1.82 (0. Using the NAPRTCS database. from the paucity of published reports describing the outcomes of infants who initiate dialysis during the ﬁrst month of life.81) Hazard ratios (HR) are adjusted for variables shown.80. February 2007 e471 .39) 1. or time to death of the patients in this study (Table 4). P ϭ . multivariate analysis revealed no signiﬁcant difference in time to death between the 2 age groups (hazard ratio: 0.59–1.88) 0.98) 0. P ϭ . Data were available for 130 neonates who initiated dialysis during 1992-1998 and for 63 neonates who initiated dialysis during 1999-2005. Furthermore.67 (0.19–2. P ϭ . a primary renal diagnosis of either dysplasia or obstruction was signiﬁcantly associated with a reduction in the relative hazard for time to termination and time to death and tended toward a reduced relative hazard for time to transplant (Table 4). Log rank test.65) 0.28–0. there was no signiﬁcant difference in time to death between the neonates and older children (P ϭ .01) 0.22) 1. Among those infants who initiated dialysis during the ﬁrst month of life.036. Among those ever hospi- FIGURE 2 Time to death: neonates versus older children. These ﬁndings indicate that a signiﬁcant propor- died having terminated their initial dialysis course for another reason (eg. Fig 4).80 (0.57–1.75–1. Number 2. 95% CI: 0. DISCUSSION For physicians and parents alike. neonates had a greater mean number of hospital days than older children (54 vs 39. change of modality. The age at which dialysis was initiated had no effect on the likelihood of dialysis termination over time. Neonates who initiated dialysis between 1999 and 2005 (n ϭ 63) were as likely to transition to renal transplantation as were neonates who initiated between 1992 and 1998 (n ϭ 130).111).401 (not signiﬁcant).56-1.02 (0.80 (0.47) 1. 2010 PEDIATRICS Volume 119. Furthermore. Provided by Indonesia:AAP Sponsored on May 7. time to transplant. Neonates (n ϭ 193) and older children (n ϭ 505) had similar survival within 5 years of initiating dialysis. application of the Wilcoxon 2-sample test indicated that this survival advantage was statistically signiﬁcant (P ϭ .14 (0. ϳ1 in 8 neonates recovered native kidney function.47 (0. Overall.55 (1.45–0.30 (0.77 (0.47) 0. or recovery of native kidney function).95–1.15 (0. the goals of our study were to gain further insight into the outcome of neonates with ESRD and to provide information to physicians and families that would assist in the decision-making process.85–1.97–1.02) 0.52) 1. neonates in the recent and past cohorts transitioned to renal transplantation at similar rates (Fig 3).
we hypothesized that neonates who initiated long-term dialysis in recent years would have better outcomes than those who initiated dialysis ϳ1 decade ago. primary renal diagnosis. The converse also may have occurred: a truly small center may have been able to register each of its patients Downloaded from www. the calculated rate of dialysis-treated neonatal ESRD in our study is very similar to that reported in Britain and Ireland. Furthermore. 2010 . It is conceivable that some of the centers considered small in this study are actually large institutions that care for many infants with ESRD but lack data entry support for the enrollment of patients in the NAPRTCS database. Because the likelihood and duration of hospitalization were substantially different between the 2 age groups. because they spent ϳ8 weeks in the hospital compared with ϳ6 weeks for older children. these ﬁndings indicate that neonates with ESRD (and their families) incur signiﬁcant human and ﬁscal costs of long-term dialysis. The duration of hospitalization also was longer for neonates. these same neonates enjoyed better survival in comparison with those treated in the earlier cohort. the relative frequency of these primary renal diagnoses were taken into consideration in our comparisons of age group-speciﬁc termination and survival outcomes. in part. tion of neonatal dialysis patients will successfully transition off long-term dialysis. We speculate that the improvement in outcomes in the more recent cohort is attributable. such bias likely would be applied equally to both age groups in this study. the presence of signiﬁcant comorbid conditions may preclude long-term dialysis as a bridge to renal transplantation. this overall mortality risk was only marginally higher than that observed in older children. the ﬁndings presented in this report reﬂect the outcomes of those neonates whose associated anomalies (if any) were judged to be insufﬁcient to preclude long-term dialysis. To address this possible confounding factor.pediatrics. The associated morbidities of these conditions are quite different (ie. with ϳ1 in 4 neonates expiring after the initiation of dialysis. The fact that NAPRTCS is a volunteer registry also may have limited our ability to determine the effect of center size on termination and survival outcomes. Only 1 in 5 neonates escaped inpatient treatment after the initiation of dialysis. whereas older children were more likely to suffer from CNS. One potential limitation of this study is the difference e472 CAREY et al between the 2 age cohorts in the frequency of each primary renal diagnosis. P ϭ . to the advancement of medical and surgical techniques over time.20 Because the NAPRTCS database seems to be in accord with other published studies and registries. We found that neonates were more likely to be diagnosed with renal dysplasia or obstructive uropathy. Furthermore. Hence. countries in which the outcome of every dialysis patient is recorded in a registry biannually. and it did not reach statistical signiﬁcance. as well as to the accrual of experience by medical centers that provide care for these infants. Neonates who initiated dialysis between 1999 and 2005 (n ϭ 63) had more favorable survival than did neonates who initiated between 1992 and 1998 (n ϭ 130). the survival data presented in our study closely resemble that reported for young dialysis patients in Australia and New Zealand. we performed multivariate analyses taking into consideration. The voluntary nature of the NAPRTCS database is another limitation of this study. Neonates with renal dysplasia or obstructive uropathy are at risk for associated congenital anomalies. Provided by Indonesia:AAP Sponsored on May 7. we believe that is it a valid tool to describe the outcomes of long-term dialysis initiated during the ﬁrst month of life in North America. the majority of infants who initiated long-term dialysis during the ﬁrst 24 months of life required hospitalization. Furthermore. Although it is reasonable to speculate that some medical centers may report only their successful cases. Indeed.1 Moreover. among other factors. Although these analyses revealed that dysplasia and obstruction were associated with better survival outcomes. Wilcoxon test. However. Selection bias also may have been introduced into this study by the difference between the 2 age cohorts in the frequency of each primary renal diagnosis. so each could uniquely impact the likelihood of transplantation and long-term survival. The likelihood of mortality was considerable for all of the children in our study. respiratory insufﬁciency versus infection and thrombosis). In our study. either true malformations or deformations. These data suggest that the long-term survival rates of neonates and older infants with ESRD are similar. even after adjusting for confounding factors. When we designed this study. In such cases. thus excluding these neonates from the NAPRTCS database. because of severe oligohydramnios. product limit analysis revealed no difference in survival between the 2 age groups. we found that a greater percentage of neonates in the more recent cohort had transitioned to transplantation within 3 years of initiating dialysis.FIGURE 4 Time to death: past versus recent cohorts.org.036.
with NAPRTCS. This study was also supported as by a grant from the National Institutes of Health (HD-07162). Trompeter RS. Accessed August 6. National Center for Health Statistics.115: 449 – 454 9.23.gov/popest/estimates. Fine RN. Kari JA. by age group.22 With these and other improvements in pretransplant care. 2000.ca. 2005 16. 2006 19. Long-term outcome of peritoneal dialysis in infants. Roy S. Fernando ON. If 1 assumes a priori that high-volume centers would achieve better outcomes because of their greater experience. REFERENCES 1.136:24 –29 4.8:325–334 10. popular tables. Warady BA. 1974 to 2003. Available at: www. Long-term enteral nutrition in infants and young children with chronic renal failure. the introduction of comprehensive enteral feeding programs and growth hormone therapy has improved the growth of these infants considerably.pdf. Dillon MJ. Alexander SR.com/study/ped/resources/annlrept2004. 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Jaskula and Robert S. originally published online Jan 15.org. tables) or in its entirety can be found online at: http://www. Talley. Carey.org/cgi/content/full/119/2/e468#otherarticl es This article.pediatrics.pediatrics. 2007.org/cgi/content/full/119/2/e468#BIBL This article has been cited by 5 HighWire-hosted articles: http://www. Sally A.org/cgi/content/full/119/2/e468 This article cites 19 articles. 3 of which you can access for free at: http://www. Provided by Indonesia:AAP Sponsored on May 7.pediatrics.shtml Citations Subspecialty Collections Permissions & Licensing Reprints Downloaded from www. 2010 .org/misc/reprints.pediatrics.1542/peds. along with others on similar topics.pediatrics.pediatrics. Janet M.pediatrics.shtml Information about ordering reprints can be found online: http://www.org/misc/Permissions.org/cgi/collection/genitourinary_tract Information about reproducing this article in parts (figures.2006-1754 Updated Information & Services References including high-resolution figures.119. Lynya I.e468-e473. Mathias Pediatrics 2007. Sehring.Outcomes of Dialysis Initiated During the Neonatal Period for Treatment of End-Stage Renal Disease: A North American Pediatric Renal Trials and Collaborative Studies Special Analysis William A. DOI: 10. can be found at: http://www. appears in the following collection(s): Genitourinary Tract http://www.