http://informahealthcare.com/jmf ISSN: 1476-7058 (print), 1476-4954 (electronic) J Matern Fetal Neonatal Med, Early Online: 1–5 ! 2014 Informa UK Ltd. DOI: 10.3109/14767058.2014.960832

ORIGINAL ARTICLE

Exchange transfusion for neonatal hyperbilirubinemia: an 8-year single center experience at a tertiary neonatal intensive care unit in Turkey Nilay Hakan, Aysegul Zenciroglu, Mustafa Aydin, Nurullah Okumus, Arzu Dursun, and Dilek Dilli J Matern Fetal Neonatal Med Downloaded from informahealthcare.com by Kainan University on 04/26/15 For personal use only.

Division of Neonatology, Department of Pediatrics, Dr. Sami Ulus Maternity and Children Training and Research Hospital, Ankara, Turkey

Abstract

Keywords

Objective: The aim of present study was to evaluate the indications and the complications associated with neonatal exchange transfusion (ET) performed for hyperbilirubinemia. Methods: This study included overall 306 neonates who underwent ET between 2005 and 2012. The demographic characteristics of patients, causes of jaundice and adverse events occurred during or within 1 week after ET were recorded from their medical files. Those newborns that underwent ET were classified as either ‘‘otherwise healthy’’ or ‘‘sick’’ group. Results: Of the 306 patients who underwent ET, 244 were otherwise healthy and had no medical problems other than jaundice. The remaining 62 patients were classified as sick that had medical problems other than jaundice ranging from mild to severe. The mean gestational age was 37.6 ± 2.5 weeks and the mean peak total bilirubin levels was 25.8 ± 6.6 mg/dl. The mean age at presentation was 5.4 ± 3.8 d for all infants. The most common cause of hyperbilirubinemia was ABO isoimmunization (27.8%). None of newborns died secondary to ET. Three infants had had necrotizing enterocolitis, and also three infants had had acute renal failure. The most common encountered complications of ET procedure were hyperglycemia (56.5%), hypocalcaemia (22.5%) and thrombocytopenia (16%). Conclusions: Our data showed that ABO isoimmunization was the most common cause of hyperbilirubinemia. Even mortality was not seen, very rare but major gastrointestinal and renal complications were associated with ET. The majority of adverse events associated with ET were laboratory abnormalities mainly hyperglycemia, hypocalcaemia and thrombocytopenia which were asymptomatic and treatable.

Complication, etiology, exchange transfusion, neonatal hyperbilirubinemia

Introduction Jaundice is a common neonatal problem. This may be due to an imbalance between production and elimination of bilirubin, a breakdown product of hemoglobin, which leads to hyperbilirubinemia and predisposes to the risk of encephalopathy and long-term sequel if not managed promptly. Bilirubin formation in newborns is two to three times greater than in adults owing to the shorter life span of fetal hemoglobin compared to adult hemoglobin. Besides, the developmentally immature liver and gastrointestinal tracts of newborns are unable to excrete bilirubin as quickly as it is produced [1]. Exchange transfusion (ET) has an important role in preventing kernicterus in the treatment of indirect hyperbilirubinemia of the newborn. The bilirubin level at which ET is indicated remains controversial [2–5]. This is because it is

Address for correspondence: Dr. Mustafa Aydın, Division of Neonatology, Department of Pediatrics, Firat University School of Medicine, 23119, Elazig/Turkey. Tel: +90(424)2333555. Fax: +90(424)2388096. E-mail: [email protected]

History Received 17 June 2014 Revised 2 August 2014 Accepted 29 August 2014 Published online 22 September 2014

very difficult to define the risk of bilirubin encephalopathy in various categories of patients, such as those with or without hemolysis, healthy or sick, term or premature. The recommendations attempt to balance the benefits of preventing bilirubin toxicity with the risks of ET. However, there are few recent reports of the complications rates from ET or attempts to stratify the risk of adverse events based on clinical condition [1,6]. Therefore, the aim of this study was to investigate the etiology of severe hyperbilirubinemia and the incidence of adverse events attributable to ET in a patient population seen in our institution over the past 8 years.

Methods The study included newborn infants who underwent ET due to indirect hyperbilirubinemia in which admitted to the neonatal intensive care unit (NICU) of Dr. Sami Ulus Maternity and Children Training and Research Hospital, Ankara, Turkey. Preterm is defined as if babies born alive before 37 weeks of gestation. Based upon screening program, all newborns delivered in our hospital were assessed for clinical risk factors which causing severe hyperbilirubinemia

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and/or, if required, evaluated by pre-discharge serum bilirubin. The American Academy of Pediatrics (AAP) guidelines [4,5] are used for the management of hyperbilirubinemia for newborn infants 35 weeks’ gestation. But AAP does not guide the babies less than 35 weeks of gestation with indirect hyperbilirubinemia for phototherapy and ET. However, there are some advised institutional practices in the literature for preterm infants 535 week’s gestation [6,7], which are used in our NICU. All newborns admitted to our NICU with severe hyperbilirubinemia first received phototherapy, of them, in which phototherapy failed to fall total serum bilirubin level to desired level and/or those with signs of acute bilirubin encephalopathy underwent ET. During the 8-year period from January 2005 to December 2012, infants were selected if they had discharged with the diagnosis of severe hyperbilirubinemia and/or procedure code for ET in their medical record. After excluding records for patients who underwent only partial ET for polycythemia and severe anemia, the medical records of the 306 remaining patients were reviewed in details. The demographic characteristics and clinical data of the patients were recorded from their medical files. Laboratory investigations, including complete blood count and reticulocyte count, blood group typing, Rhesus and direct Coombs tests, blood smear, blood culture, glucose6-phosphate dehydrogenase activity, and pre- and post-ET levels of direct and indirect bilirubin, calcium, potassium, hemoglobin, and glucose in blood were performed.

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ETs were performed by the neonatology fellow or attending neonatologists, or by pediatric residents under their direct supervision. During the procedure, calcium gluconate was not used to neutralize the probable side effect of citrate. ET-related complications An adverse event was defined as any complication that occurred within 7 d of an ET. For adverse events the following definitions were used- hypoglycemia: serum glucose of 540 mg/dl; hyperglycemia: serum glucose of 4150 mg/dl; hypocalcaemia: total serum calcium level of 58 mg/dl (for preterm newborn 57.5 mg/dl); thrombocytopenia: platelet count of 5100 000/mm3; bradycardia: heart rate dropping to 580 beats per minute; apnea: cessation of respirations for 420 s; necrotizing enterocolitis (NEC) defined according to modified Bell’s criteria [9]. Such as apnea, electrolyte changes, sepsis and NEC were recorded only if they occurred after the first ET in these infants. We did not describe causes and adverse effects after second ET in our study cases. Statistical analyses Statistical analyses were performed using the SPSS 17.0 for Windows software (SPSS Inc, Chicago, IL) pocket program. The demographic and clinical characteristics of the patients were analyzed descriptively. The data were expressed as mean ± standard deviation. A p value 0.05 was considered significant.

Results Indications and comorbidities The cause of jaundice reported in the record was classified in the following way: Rh disease was defined as jaundice in Rhpositive newborns from Rh-negative mothers with elevated titers to the Rh antigen and evidence of hemolysis. ABO disease was defined as jaundice in newborns with positive direct Coombs test against the A or B antigens from type 0 mothers; hemolysis was often but not always documented. Other antigen sensitization was defined as hemolytic jaundice in Coombs positive newborns from mothers with antibodies to other blood group antigens. The causes of hyperbilirubinemia, maximum level of bilirubin at the time of ET, adverse events related to the procedure, and associated therapeutic interventions were also recorded. Those newborns admitted solely for hyperbilirubinemia were classified as healthy group. The remaining infants those with any other medical conditions were classified as sick group. This condition included hydrops fetalis, respiratory distress, need for assisted ventilation, presumed sepsis, and other morbidity. Presumed sepsis was noted if there were clinical signs of infection treated with antibiotic therapy 5 d but without a positive blood culture. All bloods used for ET were 55-d-old, washed and reconstituted with fresh frozen plasma to obtain a hematocrit of 50% to 55%. The blood was anti-coagulated with citrate phosphate dextrose adenosine-1. The double-volume (150–180 ml/kg) exchange procedures were generally completed by repeatedly removing and replacing small aliquots of blood (5–7 ml/kg) according to standard published guidelines in every case using a single line (umbilical vein) [8].

During the 8-year study period, there was 7450 general admission to the NICU, of whom 1862 (25%) were received phototherapy due to hyperbilirubinemia. Among patients who received phototherapy, 306 underwent to ET (16.4%). Of patients who underwent to ET, 15% (n ¼ 46) were hospitalized sick newborns because of any reason, 8.1% (n ¼ 25) were hospitalized otherwise healthy newborns at obstetrics and gynecology service, while the remaining most patients (76.7%, n ¼ 235) were the newborns referred from an outside hospital for severe hyperbilirubinemia. Characteristics of the study population are shown in Table 1. Of these, 244 were otherwise healthy and had no medical problems other than jaundice (group 1). The remaining 62 patients were classified as sick because of their additional medical problems (group 2); nine had required mechanical ventilation for hyaline membrane disease and the remainder had an assortment of conditions ranging from mild to severe (Table 2). The overall 306 patients underwent a total of 337 ETs. Of these, 119 patients were under 37 weeks’ gestational age. Table 1. Characteristics of the study population.

Gestational age, week Body weight, g Peak total bilirubin (mg/dl) Presenting age (day) *Otherwise healthy infants. ySick infants.

*Group 1 (n ¼ 244)

yGroup 2 (n ¼ 62)

All infants (n ¼ 306)

37.9 ± 2.0 3115 ± 544 25.8 ± 6.4 5.3 ± 3.6

36.2 ± 3.6 2646 ± 783 25.7 ± 7.6 5.7 ± 4.5

37.6 ± 2.5 3020 ± 628 25.8 ± 6.6 5.4 ± 3.8

Exchange transfusion for neonatal hyperbilirubinemia

DOI: 10.3109/14767058.2014.960832

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Table 2. Additional medical problems before exchange transfusion in the group 2 infants*. Patient

n

%

The patients required mechanical ventilation (n ¼ 9) Respiratory distress syndrome Severe asphyxia Sepsis Coarctation of aorta

4 2 2 1

6.4 3.2 3.2 1.6

20 13 7 4 3 2 1 1 1 1

32.2 21 11.4 6.5 4.9 3.2 1.6 1.6 1.6 1.6

The patients not required mechanical ventilation (n ¼ 53) Sepsis Dehydration Respiratory distress syndrome Hydrops fetalis Perinatal asphyxia Ventricular septal defect and pulmonary hypertension Glycogen storage disease type 1 Familial hemophagocytic lymphohistiocytosis Galactosemia Duodenal atresia *Sick infants.

*Group 1 (n ¼ 244)

1 2 3 Total

Table 4. Causes of neonatal hyperbilirubinemia.

Causes of jaundice n (%) Rh disease ABO incompatibility Subgroup incompatibility zG6PD deficiency Idiopathic Others

*Group 1 (n ¼ 244)

yGroup 2 (n ¼ 62)

All infants (n ¼ 306)

34 79 18 16 79 18

11 6 5 4 9 27

45 85 23 20 88 45

(13.9) (32.3) (7.3) (6.5) (32.3) (7.3)ô

(17.7) (9.6) (8) (6.5) (14.5) (43.5)x

(14.7) (27.8) (7.5) (6.5) (28.7) (14.7)

*Otherwise healthy infants. ySick infants. zGlucose-6-phosphate dehydrogenase. ôCephalohematoma (n ¼ 12), adrenal hemorrhage (n ¼ 4), pyruvate kinase deficiency (n ¼ 2). xCephalohematoma (n ¼ 7), adrenal hemorrhage (n ¼ 5), acute hemolytic transfusion reaction (n ¼ 5), hereditary spherocytosis (n ¼ 4), bruising due to leg trauma (n ¼ 4), pyruvate kinase deficiency (n ¼ 2). Table 5. Adverse events probably due to exchange transfusion.

Table 3. Number of exchange transfusions.

Number of exchange transfusions

3

Complications yGroup 2 (n ¼ 62)

Patients (n)

Transfusions (n)

Patients (n)

Transfusions (n)

226 18 – 244

226 36 – 262

53 5 4 62

53 10 12 75

*Otherwise healthy infants. ySick infants

*Group 1 yGroup 2 All infants n (%) n (%) n (%)

Death – Sepsis 1 (0.4) 3 Apnea or bradycardia required PPVz 3 (1.2) 6 Acute renal failure 1 (0.4) 2 Necrotizing enterocolitis 1 (0.4) 2 Portal vein thrombus 15 (6.1) 8 Hypoglycemia 1 (0.4) 2 Hyperglycemia 149 (61) 24 Hypocalcaemia 56 (22.9) 13 Thrombocytopenia 37 (15.1) 12

– – (4.8) 4 (1.3) (9.6) 9 (2.9) (3.2) 3 (0.9) (3.2) 3 (0.9) (12.9) 23 (7.5) (3.2) 3 (0.9) (38.7) 173 (56.5) (20.9) 69 (22.5) (19.3) 49 (16)

*Otherwise healthy infants. ySick infants. zPositive pressure ventilation.

For premature infants, the mean gestational age was 34.4 ± 2.0 weeks (26 to 36 weeks), and the mean birth weight was 2418 ± 508 g (800 to 3330 g). The male/female ratio for all newborns was 1.3. Group 2 infants underwent more multiple transfusions than group 1 infants (Table 3). During follow-up, kernicterus was determined in 17 infants whom underwent ET. Among them two were ex-preterm infants. Of the patients with kernicterus, 11 had had a serum bilirubin level of over the 30 mg/dl. Main causes of hyperbilirubinemia that required ET was ABO incompatibility (27.8%), Rh disease (14.7%), idiopathic (28.7%), and other causes (14.7%). The causes of neonatal hyperbilirubinemia that required ET are shown in Table 4. The mean peak total serum bilirubin level in all infants was 25.8 ± 6.6 mg/dl. The mean age at presentation was 5.4 ± 3.8 d for all infants. The mean duration of the ET was 84.2 ± 27.8 min (range 45–180). Multiple ET was required in 8.8% of all neonates who included to study. A total of three deaths occurred within 7 d after the ET, none of which were related to the ET. Two infants died because of each cardiac failure and familial hemophagocytic lymphohistiocytosis. The third one was extremely premature with 27 weeks’ gestational age and 850 g birth weight. He had severe hydrops and died after a few days following multiorgan system failure. Twenty-eight infants (9.1%) experienced severe complications attributable to ET. These complications included apnea

or bradycardia with cyanosis requiring positive pressure ventilation during or immediately after ET (n ¼ 9, 2.9%), rectal bleeding leading to work-up and brief medical treatment for presumed necrotizing enterocolitis (n ¼ 3, 1%), acute renal failure (n ¼ 3, 1%), and transient bacteremia (n ¼ 4, 1.3%, one Staphylococcus aureus, one Klebsiella pneumoniae, two Escherichia coli; Table 5). The most common adverse events were hematologic and biochemical laboratory abnormalities that included hyperglycemia (56.5%), hypocalcemia (22.5%) and thrombocytopenia (16%). These abnormalities resolved within 48 h of ET regardless of intervention that was at the discretion of the treating physician. Hyperglycemia occurred after 173 ET (56.5%); however, none of these patients was required insulin infusion. Hypocalcaemia occurred in 69 infants (22.5%) underwent ET, 18 of which (26%) required treatment (Table 6). Thrombocytopenia occurred following 49 ET (16%), 13 of which (26.5%) received treatment with platelet transfusions (Table 7). Overall, 77 of the 337 adverse events (22.8%) required therapy specific to the complication. The most common treatment was for laboratory abnormalities, all of which resolved within 48 h. Adverse events still present at the time of discharge were the persistence of portal vein thrombus which was asymptomatic.

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Table 6. Complications associated with hypocalcaemia.

Cardiac arrest associated with hypocalcaemia Serious, transient complicationsz Asymtomatic hypocalcemia (treated) Asymtomatic hypocalcemia (untreated)

*Group 1 (n ¼ 244) n (%)

yGroup 2 (n ¼ 62) n (%)

– 3 (1.2%) 14 (5.8%) 39 (16%)

– 1 (1.6%) 4 (6.5%) 8 (12.9%)

*Otherwise healthy infants. ySick infants. zECG changes, pedal spasm, irritability, marked jitteriness.

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Table 7. Complications associated with thrombocytopenia.

Death or permanent sequelaez Serious, transient complicationsô Asymtomatic, but needed platelet transfusion Asymtomatic thrombocytopenia (not treated)

*Group 1 (n ¼ 244) n (%)

yGroup 2 (n ¼ 62) n (%)

– 4 (1.6%) 6 (2.4%) 27 (11%)

– 3 (4.8%) 7 (11.2%) 2 (3.2%)

*Otherwise healthy infants. ySick infants. zSymptomatic pulmonary hemorrhage, intra-ventricular hemorrhage. ôPetechial rash, rectal bleeding, hematuria, bleeding umbilicus.

Discussion Severe neonatal jaundice is a pediatric emergency because it may cause to kernicterus which can result in chronic handicapping conditions like sensorineural deafness or cerebral palsy in those who survive. The goal of the management of severe neonatal jaundice is therefore to rapidly reduce the serum bilirubin level to prevent kernicterus [8,10]. ET remains the gold standard for effective treatment of severe neonatal hyperbilirubinemia. Although reports show a progressive decline over the years in the number of neonates needing ET, it is still required in up to 7% of neonates admitted to NICU with severe hyperbilirubinemia [11,12]. This decline in the number of ET is likely multifactorial with contributions from widespread use of effective phototherapy, the development of anti-Rh globin for Rh-negative mothers, advances in both prenatal and postnatal care, such as middle cerebral artery Doppler studies to non-invasively follow fetal anemia, and intravenous immunoglobulin treatment for patients with hemolysis [12–14]. However, the ET rate in developing countries, such as in Turkey, was high [15]. This is possibly due to the shortage of facilities and late presentation to the hospital. Unfortunately, the more powerful and effective phototherapy units, and different newly intervention models like the fibreoptic phototherapy blanket were not available in our NICU during study period. In addition, low socio-cultural level of our study population, and late referral from the primary level health care facilities might account for this high incidence of ETs performed in our NICU. In the literature, ABO hemolytic disease of newborns was also reported as the most common cause of ET in term neonates. ABO hemolytic disease has been reported as the cause of ET by Badiee [16], Davutoglu et al. [17], Bhat et al. [18] and Sanpavat [19] at the rates of 22.5%, 38%, 25% and 21.3%, respectively. Likely, ABO immunization was found to

be the most common cause of ET in our study. The mean age at admission was 5.4 ± 3.8 d in the present study. In the literature, the mean age at presentation was 4.4 d in Badiee’s study [16] and approximately 4.6 d in the study of Sgro et al. [20]. The requirement for more than one ET in present study was lower the rates reported by Badiee (13.2%) [16], Patra et al. (20%) [21], Sanpavat (10.9%) [19] and Abu-Ekteish et al. (11.9%) [1]. This difference could be explained by the different ethnic and geographic characteristics of our study population. There are limited data regarding the adverse events of ET in newborn infants with indirect hyperbilirubinemia. Best to our knowledge, present study is the largest series in the literature in this topic. The results of this observational study reveal a high rate of adverse events associated with ET for neonatal hyperbilirubinemia. However, in our study the majority of these events are asymptomatic, transient and treatable laboratory abnormalities such as hyperglycemia, hypocalcemia and thrombocytopenia. Steiner et al. [12], in their detailed study covering 21 years, reported a rate of hypocalcemia 38% and thrombocytopenia 38%. Hosseinpour Sakha et al. [22] described adverse events of ET during 2006– 2008. According to their study, the most common events were thrombocytopenia (36%) and hypocalcemia (25%). In our study, severe adverse events associated with ET were apnea or bradycardia with cyanosis requiring positive pressure ventilation, necrotizing enterocolitis, acute renal failure, and transient bacteremia. Furthermore, no case of ET-related mortality was observed. One of the deaths was associated severe complications of prematurity. Other deaths related to an underlying primary disease. In the mid-1970s when Keenan et al. [10] reported a serious adverse event rate of 5.2% and a mortality rate of 0.5%. In 1997, Jackson [8] reported data on 106 neonates from two NICUs who underwent 140 ETs from 1980 to 1995. He described a high rate of serious complications in the 25 neonates (12%) with significant preexisting comorbidities, as well as an overall mortality attributable to ET was 2%. In 2004, Patra et al. [21] reported data on 55 neonates who underwent 66 ETs from 1992 to 2002. They reported a high rate of ET-related adverse events (74%) and a mortality rate of 2%. In 2007, Steiner et al. [12], reported no cases of ET-related mortality in 107 patients who underwent 141 ETs from 1986 to 2006. In 2011, Bhat et al. [18] observed a mortality rate of 2.1%. The results of these studies have implications for monitoring both group 1 and group 2 infants who undergo ET. Although apnea, bradycardia, and cyanosis occur rarely during ET of healthy infants, cardiorespiratory and oxygen saturation monitoring appear indicated. In both group 1 and group 2 infants, routine measurement of both ionized calcium and platelet count after ET is indicated, given the occasionally severe complications associated with hypocalcemia and thrombocytopenia even in healthy population. Because many of the complications of ET are probably unavoidable, the best way to reduce complications is to prevent the need for ET. The use of effective phototherapy, including optimization of the wavelength and power of the lamps, and maximization of skin light exposure including use of fiberoptic pads, can greatly reduce the need for ET. Other innovative approaches for treating jaundice include

Exchange transfusion for neonatal hyperbilirubinemia

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DOI: 10.3109/14767058.2014.960832

intravenous gammaglobulin in Rh-sensitized newborns. Besides bilirubin levels should be monitored closely in newborns in which ABO isoimmunization was determined at birth [8]. This study and our clinical experience shows that many affected babies arrive late to the hospital with higher bilirubin level or signs and symptoms of bilirubin encephalopathy. This delay in seeking medical approach could be due to lack of awareness or inadequate knowledge of parents. It could also be due to failure in recognizing the risk factors for development of severe hyperbilirubinemia by health care professionals. In conclusion, our results indicated higher morbidity rates related to application of ET in the treatment of hyperbilirubinemia. It should be taken into account when weighing the risk of an event from ET against the risk of bilirubin encephalopathy. The rare possibility of sepsis, necrotizing enterocolitis and acute renal failure should also be considered. Despite these considerations, ET remains a feasible and relatively safe method to treat severe neonatal hyperbilirubinemia. In order to reduce the necessitating for ET procedure and hence avoid ET-related morbidity; bilirubin levels should be monitored closely in newborns, especially those in highrisk group, such as having ABO and Rh incompatibility.

5. 6. 7. 8. 9. 10. 11. 12.

13. 14. 15. 16.

Declaration of interest The authors report no any conflict of interest and any financial relationship.

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Exchange transfusion for neonatal hyperbilirubinemia: an 8-year single center experience at a tertiary neonatal intensive care unit in Turkey.

The aim of present study was to evaluate the indications and the complications associated with neonatal exchange transfusion (ET) performed for hyperb...
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