Incidence, Course, and Prediction of Hyperbilirubinemia in Near-Term and Term Newborns
* Division of Neonatology, Department of Pediatrics, Gülhane Military Medical Academy, Ankara, Turkey
Department of Clinical Biochemistry, Gülhane Military Medical Academy, Ankara, Turkey
Division of Neonatology, Department of Pediatrics, Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children’s Hospital, Ankara, Turkey
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
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Objective. In this study, we investigated prospectively the incidence of significant hyperbilirubinemia and demographic and laboratory characteristics and pattern of serum bilirubin levels of near-term newborns (35–37 weeks’ [245–265 days’] gestation) by comparing them with those of term newborns (38–42 weeks’ [266–294 days’] gestation) longitudinally in the first 7 days of life; we also aimed to determine the value of an early (6th-hour) serum bilirubin measurement in predicting the development of significant hyperbilirubinemia later during the first week of life in near-term newborns.
Methods. Serum total bilirubin measurements were initially made at the 6th hour of life and repeated daily for the next 4 days, and a last measurement was performed on the 7th day (150th hour) in 219 term newborns (term group) and 146 near-term newborns (near-term group). Newborns with serum total bilirubin levels of 
8 and 12 mg/dL on day 2, 12 and 15 mg/dL on day 3, and 14 and 17 mg/dL on days 4, 5, and 7 for birth weights 2000 to 2500 g and >2500 g, respectively, were defined to have significant hyperbilirubinemia, and phototherapy treatment was started. The predictive ability of the 6th-hour serum total bilirubin value in determining the development of significant hyperbilirubinemia in the near-term group was assessed on the basis of the placement of any of the first week’s serum bilirubin measurements in the 95th percentile of the study population. A Gaussian distribution curve, the 5th, 30th, 60th, and 95th percentiles, and 4 percentile tracks were obtained from mean serum total bilirubin values. On the basis of the percentile tracks with various sensitivity, specificity, and negative and positive predictive values, a nomogram demonstrating the 4 percentile tracks as risk-zone demarcators with divided risk zones was produced.
Results. Twenty-three newborns (10.5%) in the term group and 37 newborns (25.3%) in the near-term group had significant hyperbilirubinemia and required phototherapy. When the daily mean serum bilirubin levels of the 2 groups were compared, the first 4 days’ values did not significantly differ between the 2 groups, whereas the 5th and 7th days’ values were significantly higher in the near-term group. There were significant differences between the 2 groups with respect to the incidence of significant hyperbilirubinemia, hematocrit, Apgar score, and mode of delivery. On the age-specific nomogram, the zone >95th percentile was labeled as high risk, and that <5th percentile was labeled as low risk. Serum total bilirubin values between the 5th and 30th, 30th and 60th, and 60th and 95th percentiles were designated as being in the low-intermediate, intermediate, and high-intermediate risk zones, respectively. The 5th and 95th percentiles on the nomogram had the highest sensitivity (100%) and specificity (98.2%), respectively, in predicting the subsequent development of significant hyperbilirubinemia.
Conclusions. Near-term newborns should not be treated as term newborns in the approach to management of hyperbilirubinemia, because infants of 35 to 37 weeks’ gestation had significantly lower birth weights, significantly higher serum total bilirubin levels on days 5 and 7, and were 2.4 times more likely to develop significant hyperbilirubinemia than those of 38 to 42 weeks’ gestation in the present study. In near-term newborns of 35 to 37 weeks’ (245 to 265 days’) gestation, the decision to diagnose and treat significant hyperbilirubinemia should be made on the basis of risk status (percentile distribution of the serum bilirubin values on postnatal age) rather than using birth-weight-based thresholds. A nomogram constructed from daily serum bilirubin values of each population, as we present herein, can be used in assessing the age (hour)-specific jaundice risk (high, intermediate, or low) of each near-term newborn.
Key Words: early discharge • full-term • hyperbilirubinemia • jaundice risk • near-term • newborn • prediction • term
Although there is no universally accepted definition of the word "near-term" regarding gestational age of newborns, it has been used recently1 to describe those infants who are not term according to the World Health Organization definition (38–42 weeks) but who are still cared for in well-infant nurseries based on the observation that many, if not most, of these infants are of 2500 g in birth weight. Although the 1994 American Academy of Pediatrics guidelines included infants with 37 completed weeks (259 days) of gestation as term,2 infants 35 to 38 weeks of gestation may not nurse as well as more-mature infants,2,3 and neonatal problems such as hypoglycemia and respiratory distress syndrome are encountered more frequently in this group of infants than term newborns in clinical practice.4 Near-term newborns have usually been analyzed in the same category as their truly mature counterparts even in several of the more-recent studies concerning neonatal hyperbilirubinemia,5–10 although the strong correlations between decreasing gestational age and increasing risk for significant hyperbilirubinemia,3,5,11,12 decreasing hepatic bilirubin conjugation capacity,13 and decreasing activity of the uridine diphosphate glucuronyl transferase enzyme14 are well known. To our knowledge, near-term newborns have not been compared previously with term newborns with respect to the epidemiology of neonatal jaundice and course of serum bilirubin levels in the first few days of life in a longitudinal and prospective manner. In this study, we therefore aimed to investigate prospectively the incidence of significant hyperbilirubinemia, demographic and laboratory characteristics, and pattern of serum bilirubin levels of the near-term newborns by comparing them with those of the term newborns longitudinally in the first 7 days of life; we also aimed to determine the value of an early (6th-hour) serum bilirubin measurement in predicting the development of significant hyperbilirubinemia later during the first week of life in near-term newborns by comparing the near-term newborns who became jaundiced and those who did not and by constructing an age (hour)-specific percentile-based nomogram from daily serum bilirubin values of infants.
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METHODS |
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This study was performed at the Division of Neonatology of Hacettepe University Faculty of Medicine between November 2001 and May 2002. During the study period, all newborns with a gestational age between 35 and 42 completed weeks (245–294 days) were consecutively enrolled in the study. Gestational ages of newborns were determined according to the first day of the mother’s last menstrual period (by the mother’s statement) and were additionally confirmed by the Ballard scoring system15 and antenatal ultrasonographic estimation or obstetric records if present. Infants whose mothers could not recall the exact date (first day) of last menstrual period and/or those who had a critical discrepancy (
2 weeks) between 2 methods on gestational-age determination were not included in the study. Newborns with a gestational age of <35 weeks (
244 days) and >42 weeks (295 days) were defined as preterm and postterm, respectively, and were not included in the study. Other exclusion criteria were small for gestational age and large for gestational age, determined on the basis of Colorado intrauterine growth charts,16 multiple gestation, any congenital malformation, respiratory distress, glucose-6-phosphate dehydrogenase deficiency, clinical or culture-proven sepsis, and inability to initiate or maintain oral feedings within 3 hours after birth due to various reasons. Infants with 35 to 37 weeks’ (245–265 days) gestation were defined as near-term and constituted the "near-term group," whereas those with 38 to 42 weeks’ (266–294 days) gestation were defined as term and constituted the "term group."
Hematocrit count, blood group including Rhesus, a direct antiglobulin (Coombs) test, glucose-6-phosphate dehydrogenase activity, and serum direct and indirect bilirubin levels were performed routinely in all cases at entry into the study. Serum total bilirubin measurements were made initially at the 6th hour of life (a postnatal age at which all newborns could be reached at the hospital before discharge) and were repeated daily for the next 4 days; each measurement was performed just 24 hours after the previous measurement, and a last measurement was performed on the 7th day (150th hour) to follow the pattern of serum bilirubin levels in a more longitudinal manner. Serum total bilirubin levels during the study were measured with a colorimetric method (diazotized sulfanilic acid reaction, Roche Diagnostics GmbH, Mannheim, Germany). The coefficients of variation for the measurement of serum bilirubin level were 1.3% and 1.9% for within-run and between-day measurements, respectively. Infants who had any evidence of hemolysis (Rhesus hemolytic disease, anemia, a positive direct antiglobulin test, reticulocytosis, or a peripheral blood smear compatible with hemolysis) and those newborns who had a blood group system of groups A or B born to mothers with blood group O and had a first-day (6th-hour) serum bilirubin level of 6 mg/dL were excluded from the study, because almost all (88.2%) of those in the latter group have been shown previously to develop ABO hemolytic disease.17 The definition of significant hyperbilirubinemia for newborns in the study was made on a basis considering both birth weight and postnatal age ( Table 1),2,18 and newborns diagnosed to have significant hyperbilirubinemia were started on phototherapy treatment with either of our conventional phototherapy systems.19,20 Serum total bilirubin values measured after the initiation of phototherapy were excluded from additional statistical analysis but were documented and recorded. In all cases, gender, birth weight, gestational age, delivery route, feeding pattern, maternal age, Apgar scores, whether the mother smoked or had any chronic diseases (hypertension, diabetes mellitus, etc) before or during gestation, and whether there was enclosed hemorrhage, abnormal weight loss, or any siblings with neonatal jaundice were recorded. The study was approved by the local ethics committee, and informed consent was obtained from all parents of the newborns in the study.
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Statistical data were analyzed with the descriptive analysis and the independent sample t and
2 tests. Demographic and laboratory characteristics of the near-term and term groups and of the newborns with and without significant hyperbilirubinemia in the near-term group were compared with the independent sample t and 2 tests. Daily serum total bilirubin levels of the 2 groups were compared by using the independent sample t test. The predictive ability of the 6th-hour serum total bilirubin value in determining the development of significant hyperbilirubinemia in the near-term group was assessed on the basis of the placement of any of the first week’s serum bilirubin measurements in the 95th percentile of the study population. A Gaussian distribution curve, the 5th, 30th, 60th, and 95th percentiles, and 4 percentile tracks were obtained from mean serum total bilirubin values as described in detail before.7,17,21 On the basis of the percentile tracks with various sensitivity, specificity, and negative and positive predictive values, a nomogram demonstrating the 4 percentile tracks as risk-zone demarcators with divided risk zones was produced. The zone >95th percentile was labeled as high risk, and that <5th percentile was labeled as low risk. Serum total bilirubin values between the 5th and 30th, 30th and 60th, and 60th and 95th percentiles were designated as being in the low-intermediate, intermediate, and high-intermediate risk zones, respectively. |
RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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During the study period, 886 infants (493 term, 281 near-term, and 112 preterm) were born, and only 256 term and 161 near-term newborns were eligible for entry into the study. However, the study was completed with a total of 365 newborns (219 in the term group and 146 in the near-term group), because some of the parents did not want to continue participating in the study or some of the cases were lost on follow-up. Twenty-three newborns (10.5%) in the term group and 37 newborns (25.3%) in the near-term group had significant hyperbilirubinemia and required phototherapy, with any of the first week’s serum bilirubin levels exceeding the threshold levels defined for significant hyperbilirubinemia, and the difference between the incidences of significant hyperbilirubinemia in the 2 groups was statistically significant (P < .001). When the daily mean serum bilirubin levels of the 2 groups were compared, the first 4 days’ values did not differ significantly between the 2 groups, whereas the 5th and 7th days’ values were significantly higher in the near-term group (P = .04 and P < .001, respectively; Table 2). Serum bilirubin values of the newborns in the term group made a plateau at
4 to 5 days of age and began to decrease thereafter. However, serum bilirubin values of the newborns in the near-term group demonstrated a gradual increase during the first days of life and tended to persist high through the end of the first week (Fig 1).
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Demographic characteristics of the term and near-term groups are shown in Table 2. Mean birth weight and mean gestational age were significantly higher in the term group, as expected, and there also were significant differences between the 2 groups with respect to hematocrit, Apgar score, and mode of delivery, whereas maternal age, gender, feeding pattern, maternal smoking or chronic disease, enclosed hemorrhage, and the presence of a sibling with neonatal jaundice and abnormal weight loss at the end of first week were not significantly different between the 2 groups (Table 3).
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Within the near-term group, there were no significant differences between the newborns who did and the newborns who did not develop significant hyperbilirubinemia with respect to various demographic characteristics that may be associated with the risk of developing hyperbilirubinemia, including hematocrit, birth weight, gestational age, maternal age, Apgar score, gender, delivery route, feeding pattern, maternal smoking, maternal chronic disease, enclosed hemorrhage, and the presence of a sibling with neonatal jaundice and abnormal weight loss at the end of the first week (Table 4).
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The 5th, 30th, 60th, and 95th percentile tracks were determined on an hour (age)-specific percentile-based nomogram by means of the various sensitivity, specificity, and negative and positive predictive values (5th percentile track with greatest sensitivity and negative predictive value and 95th percentile track with greatest specificity and positive predictive value) in the assessment of the predictive ability of the first (6th-hour) serum bilirubin value in determining the development of significant hyperbilirubinemia, and these tracks were used as risk-zone demarcators (Table 5; Fig 2). Serum total bilirubin levels of <4 and
9.4 mg/dL at 24 hours, <5.1 and 14.5 mg/dL at 48 hours, and <6.2 and 17.1 mg/dL at 72 hours of age were <5th and >95th percentiles for postnatal age in hours, respectively. The critical serum total bilirubin levels of 2.6 and 5.5 mg/dL at the 6th hour of life (the 5th and 95th percentiles on the nomogram) had the highest sensitivity (100%) and specificity (98.2%), respectively, in predicting the subsequent development of significant hyperbilirubinemia. Predictive ability of the 30th-hour serum bilirubin measurement in determining the development of significant hyperbilirubinemia was also calculated, because most infants may have a blood sample taken only at either 24 hours or a little later before discharge (Table 5).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Infants with 35 to 37 weeks’ gestation are usually treated in well-infant nurseries as if they were term infants and managed no differently from those of
38 weeks’ gestation with respect to diagnosis, treatment, and follow-up of hyperbilirubinemia.5–10 However, in a retrospective analysis of 51 387 newborns with birth weights of 2000 g,5 newborns with 36 to 37 weeks’ gestation have been 5.7 times at risk to develop significant hyperbilirubinemia when compared with newborns with 39 to 40 weeks’ gestation, and the risk of hyperbilirubinemia has increased with decreasing gestational age (0.6 times per week of gestation). In another study, infants born at 37 weeks’ gestation were much more likely (4 times) to develop a serum bilirubin level of 13 mg/dL than those born at 40 weeks’ gestation.22 In a retrospective study performed in a well-infant population,23 infants of 35 to 36 weeks’ (245–252 days’), 36 to 37 weeks’ (253–259 days’), and 37 to 38 weeks’ (260–266 days’) gestation have been 13.2, 7.7, and 7.2 times more likely, respectively, than those of 40 weeks’ gestation to be readmitted to hospital and require phototherapy for significant hyperbilirubinemia. In the present prospective study, infants of 35 to 37 weeks’ gestation were 2.4 times more likely to develop significant hyperbilirubinemia than those of 38 to 42 weeks’ gestation, and thus they should be considered a high-risk group because 1 in every 4 near-term newborns needs phototherapy for jaundice.
The threshold levels for defining significant hyperbilirubinemia and starting phototherapy treatment in near-term (and even very low birth weight) newborns are classically based on the birth weight24,25 but not gestational age of the newborn. For example, a newborn of 35 weeks’ gestation with a birth weight of 1900 g is recommended to be treated with phototherapy at serum bilirubin levels of 8 to 12 mg/dL, whereas a 2050-g infant with any gestational age is defined as having significant hyperbilirubinemia at serum bilirubin levels of 11 to 15 mg/dL without giving too much importance on the postnatal age of the index case. On the other hand, a 74-hour-old appropriate-for-gestational-age infant of 37 weeks’ gestation may weigh either 2450 g or 2550 g; the former is offered phototherapy with serum bilirubin levels at 11 to 15 mg/dL, whereas the latter is defined as having significant hyperbilirubinemia at serum bilirubin levels of 17 mg/dL, according to the current guidelines for the management of hyperbilirubinemia.2,24,25 Furthermore, considering the gestational age-dependent physiologic deficiency of uridine diphosphate glucuronyl transferase enzyme (which at 30 and 40 weeks’ gestations has only 0.1% and 1% of the activity found in the adult, respectively14 not reaching adult values until 8 to 15 weeks of postnatal age26), treating near-term newborns as if they were term newborns could be unjust and even harmful. Confirming those previous findings and reports, the near-term newborns had higher serum total bilirubin levels on days 5 and 7 of age in addition to the higher incidence of significant hyperbilirubinemia in comparison with the term newborns in the present study, in which we performed the jaundice risk assessment on the basis of both gestational and postnatal ages. Thus, near-term newborns should not be treated as term newborns in the approach to management of hyperbilirubinemia, and the decision to diagnose and treat significant hyperbilirubinemia should be made on the basis of risk status (percentile distribution of the serum bilirubin values on postnatal age) rather than using birth-weight-based thresholds. The later peak of serum bilirubin levels at 5 to 7 days and the tendency to persist thereafter in the near-term newborns with a pattern similar to that observed in very low birth weight newborns demonstrates the necessity of a relatively longer follow-up of these infants with respect to the development and duration of significant hyperbilirubinemia.
Although Maisels3 proposed that infants of 35 to 38 weeks’ gestation are much more likely to have a greater weight loss than their truly term counterparts in the first days of life, we did not encounter a significant difference in abnormal (10%) weight loss at the end of the first week between the 2 groups in the present study. Apgar scores and the number of newborns born vaginally were significantly higher in the term newborns in our study; however, there is no significant association described between jaundice and low Apgar scores or delivery with cesarean section.
In the present prospective study, we investigated the epidemiology of hyperbilirubinemia in the 2 gestational-age subgroups by daily serum bilirubin measurements longitudinally in the first week of life and evaluated the risk status for jaundice on a gestational and postnatal age basis. Infants of 35 to 37 weeks’ gestation had significantly lower birth weights, significantly higher serum total bilirubin levels on days 5 and 7, and were 2.4 times more likely to develop significant hyperbilirubinemia than those of 38 to 42 weeks’ gestation. Near-term newborns, thus, should not be treated as term newborns in the approach to management of hyperbilirubinemia. The relatively later peak of serum bilirubin levels at 5 to 7 days and the tendency to persist thereafter in the near-term newborns (with a pattern similar to that observed in very low birth weight newborns) necessitates the relatively longer follow-up of these infants with respect to the development and duration of significant hyperbilirubinemia. In near-term newborns of 35 to 37 weeks’ (245–265 days’) gestation, the decision to diagnose and treat significant hyperbilirubinemia should be made on the basis of risk status (percentile distribution of the serum bilirubin values on postnatal age) rather than using birth-weight-based thresholds. A nomogram constructed from daily serum bilirubin values of each population, as we present herein, can be used in assessing the age (hour)-specific jaundice risk (high, intermediate, or low) of each near-term newborn. According to our age-specific nomogram, 5th and 95th percentile tracks (serum bilirubin levels of 2.6 and 5.5 mg/dL at the 6th postnatal hour, respectively) can be used in determining the safe margins of serum bilirubin values on postnatal age for the discharge of near-term newborns from the hospital.
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FOOTNOTES |
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Received for publication Dec 3, 2002; Accepted Mar 28, 2003.
Reprint requests to (S.Ü.S.) Yeni Ulus Ecz. Hükümet Cad. 8/6, Ulus-06150, Ankara, Turkey. E-mail: nstudier{at}yahoo.com
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