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Lamellar Body Count As a Predictor of Neonatal Lung Maturity in High‐Risk

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Lamellar Body Count As a Predictor of Neonatal Lung Maturity in High‐Risk International Journal of Gynecology and Obstetrics (2005) 89,19—25 www.elsevier.com/locate/ijgo CLINICAL ARTICLE Lamellar body count as a predictor of neonatal lung maturity in high-risk pregnancies D.E.M. Abd El Aala,*, A.A. Elkhirshyb, S. Atwac, M.Y. El-Kabshc aDepartment of Obstetrics and Gynecology, Faculty of Medicine, Assiut University, Assiut, Egypt bDepartment of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt cDepartment of Clinical Pathology, Faculty of Medicine, Assiut University, Assiut, Egypt Received 12 April 2004; received in revised form 20 December 2004; accepted 20 December 2004 KEYWORDS Abstract Lamellar body count; Neonatal lung Objectives: To compare the usefulness of a lamellar body count, a fluorescence maturity; polarization assay, and the foam stability index for predicting neonatal lung High-risk pregnancy maturity in high-risk pregnancies. Setting: This study was conducted at the Department of Obstetrics and Gynecology and the Department of Pediatrics, Assiut University Hospital. Design: A prospective clinical trail. Subjects and Methods: This study was performed after recruiting 73 pregnant women, 52 with high-risk pregnancies (25 had diabetes and 27 had premature labor) and 21 with a healthy full-term singleton pregnancy as controls. All women were delivered in the Department of Obstetrics and Gynecology of Assiut University Hospital. The newborns with respiratory distress syndrome (RDS) were admitted in the neonatal intensive care unit of the Department of Pediatrics. Amniotic fluid specimens were obtained near delivery. Apgar score, vital signs, anthropometric data, and complete clinical examination results were available for all newborns, and particular emphasis was placed on signs of RDS. Results: The incidence of RDS was 44.2% in the newborns of women who had experienced a high-risk pregnancy (of these, 82.6% were born preterm and 17.4% to diabetic mothers). We found that a lamellar body count is a good screening test for predicting neonatal lung maturity. It is as good as the fetal lung maturity assay by fluorescence polarization in some respects and better in others; moreover, it is better than the foam stability index test in all respects. A lamellar body count with cutoffs of 41Â103/AL and 18Â103/AL was a good predictor of low and high risks of RDS in newborns. Values between 19Â103/AL and 40Â103/AL were the best to predict an intermediate risk of RDS. * Corresponding author. Tel: +20 105212137; fax: +20 882333327. E-mail address: [email protected] (D.E.M. Abd El Aal). 0020-7292/$ - see front matter D 2005 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijgo.2004.12.030 20 D.E.M. Abd El Aal et al. Conclusion: Lamellar body count is a good screening test for predicting the degree of neonatal lung maturity. D 2005 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. 1. Introduction 2. Subjects and methods Despite the development of artificial surfactants The study is a prospective clinical trial including and advances in respiratory support, respiratory 73 pregnant women and their newborns deliv- distress syndrome (RDS) continues to be a major ered in the obstetrics department of Assiut problem in newborns. As the successful establish- University Hospital from January 2002 to Decem- ment of adequate lung function at birth is depend- ber 2002. ent on the maturity of the respiratory system [1], There were 52 women at high risk for RDS, the ability to accurately predict neonatal lung 25 women with diabetes mellitus, and 27 maturity would be a helpful adjunct in the manage- women having preterm labor. Their newborns ment of pregnancies when premature delivery is were admitted to the neonatal intensive care expected or administration of glucocorticoids is unit of the Pediatrics Department. The control needed [2]. group included 21 pregnant women with a Lamellar bodies—1- to 5-Am lamellated struc- normal full-term singleton pregnancy who were tures synthesized by type 2 granular pneumocytes vaginally delivered and had no history of new- [3]—can be counted using commercial blood cell borns affected with RDS. Cases involving a dead analyzers [4]. These storage granules contain phos- fetus or a pregnant woman receiving cortico- pholipids, cholesterol, and several surfactant-spe- steroids, having hypertensive disease, or experi- cific proteins and become pulmonary surfactant [5]. encing premature rupture of membranes were Lamellar bodies first appear in the cytoplasm of excluded. fetal pneumocytes between the 20th and the 24th Detailed history taking, complete clinical and week of gestation [6]. The lamellar bodies abdominal sonographic examinations, and random become more numerous, larger, and are continu- blood sugar estimation were performed for each ously secreted into the fetal alveoli, and fetal participating woman. Amniotic fluid specimens breathing movements and exudation of lung fluid were obtained near delivery by amniocentesis carry these lamellar bodies into the amniotic fluid under sonographic guidance under complete asep- [7]. The phospholipid content and the laminated sis (1 case); transvaginal amniotomy (43 cases); structure of these particles change as the fetal or amniotomy during Cesarean delivery (29 lung is maturing [8]. The fetal lung maturity (FLM) cases). test consists in measuring the surfactant—albumin Each newborn received a complete clinical ratio in the amniotic fluid. Other means of examination, arterial blood gases analyses at predicting neonatal lung maturity include calcu- admission and daily thereafter, a chest radiograph lating the lecithin—sphingomyelin (L/S) ratio, (within 6—12 h when possible), and follow-up care measuring amniotic fluid levels of phosphatidyl- to monitor clinical progress. glycerol [9], performing the foam stability test A minimum of 5 mL of amniotic fluid was [10] or a fluorescence polarization assay [11], and obtained in a test tube. The specimens were well measuring amniotic fluid optical density at 650 mixed by inverting the collection tube 5—10 nm [12]; all of these tests measure some aspects times or placing it on a tube rocker for 2—5 of the pulmonary surfactant contained in the min, and its contents were transferred to a clear amniotic fluid and none is perfect for prediction test tube. Since blood and meconium may of lung maturity. The ideal test must be readily interfere with most tests, the condition of the available, inexpensive, and of good predictive specimen was then reported as uncontaminated, value. bloody, meconium-stained, xanthochromic, or The aim of this study was to compare obviously contaminated with mucus. The speci- lamellar body count, fetal lung maturity assay mens were finally divided into separate aliquots: by fluorescence polarization, and foam stability 0.5—1 mL for LBC, at least 1 mL for the index in the prediction of neonatal lung fluorescence polarization FLM assay, and at least maturity. 3—3.5 mL for the FSI test. Lamellar body count as a predictor of neonatal lung maturity in high-risk pregnancies 21 2.1. LBC Table 2 Comparison between newborns with respi- ratory distress syndrome (RDS) and newborns in the Lamellar body particles were directly counted control group according to lamellar body count (LBC), using the platelet channel of a standard hema- fetal lung maturity (FLM), and foam stability index tology cell counter (Coulter Counter Model STKS; (FSI) Coulter Electronics, Hialeah, Fla) or other Test Newborns Controls P Coulter Counter model hematology cell counters with RDS value 3 [13]. LBC Â10 /AL, meanFS.D. 20F22 70F33 0.00T FLM mg/g, meanFS.D. 20.6F9.9 58.8F13.3 0.00T FSI, dilution, mean 0.44 0.47 0.00T 2.2. FLM assay by fluorescence polarization T P b 0.001. The FLM assay was done by using the TDx/Fetal Lung Maturity II (FLM II) assay kit with the Abbott reference cutoff levels are shown in Tables 2 TDx fluorescence polarization device (Abbott Labo- and 3. ratories, North Chicago, IL) [14]. 3.1. Performance characteristics of LBC at 2.3. FSI test different cutoff values When pulmonary surfactant is in sufficient con- Using the cutoff value of 15Â103/AL to indicate centration in the amniotic fluid, the fluid is able pulmonary maturity, LBC predicted 18 cases of RDS to form a highly stable surface film that can with 5 false-negatives (for a sensitivity of 78.26% support the structure of foam. Other substances and a negative predictive value [NPV] of 90.90%); in the fluid, including proteins, bile salts, and this 15Â103/AL cutoff value resulted in no false- salts of free fatty acids, are also capable of positives (for a specificity and a positive predictive forming stable foam. But these can be excluded value [PPV] of 100%). from the film by ethanol, which competes with Using 18Â103/AL as the cutoff value to indicate these other substances for a position in the pulmonary maturity, LBC sensitivity, NPV, specific- surface film [13]. ity, and PPV were found to be the same as with a cutoff value of 15Â103/AL, as in no case were LBC values between 15 and 18Â103/AL. 3. Results Using 41Â103/AL as the cutoff value predicted all RDS cases with no false-negatives, which Of the 72 cases, there were 5 cases of provided a sensitivity and an NPV significantly congenital anomalies, 3 in the preterm group higher than with a cutoff value of 15Â103/AL (1 of anencephaly, 1 of heart disease, and 1 of (100% vs. 78.26%, P=0.00 and 100% vs. 90.90, multiple anomalies) and 2 in the infants of P=0.01, respectively) but resulted in seven false- diabetic mothers (IDM) group (1 of achondropla- positives, for a specificity and PPV less than with a sia and 1 of heart disease). The percentage of RDS in the preterm and IDM groups is shown in Table 3 Comparison between the results of tests for Table 1.
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