الفهرس 
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Abstract
Neonatal sepsis, sepsis neonatorum, and neonatal septicemia are terms that have been used to describe the systemic response to infection in newborn infants during the first 28 days of life. The infection may involve the infant globally or may be limited to just one organ (such as the lungs with pneumonia). It may be acquired prior to birth (intrauterine sepsis) or after birth (extrauterine sepsis). Viral (such as herpes, rubella), bacterial (such as group B strep) and more rarely fungal (such as Candida) causes may be implicated.
This study was carried out to:
1) Assess the role of α1-AGP as a marker in the diagnosis of EOS in full term neonates.
2) Assess the role of α1-AGP as a marker in the diagnosis of EOS compared to CRP in full term neonates.
3) Estimate the relationship between α1-AGP level and mortality in neonatal sepsis.
4) Assess the role of CRP as a marker for the diagnosis of EOS.
Our prospective case control study had been carried out in NICU of Port-Fouad general hospital of Port-Said Governorate. It was conducted on 45 patients having history of risk factors and clinical picture of sepsis either with or without positive blood culture. In addition to 20 full-term healthy neonates selected from outpatient clinic taken as a control group.
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We classified our patients into:
I- Confirmed sepsis: 30 cases (newborns presenting a clinical picture and a positive blood culture).
II- Suspected sepsis: 15 cases (newborns with clinical features and abnormalities of nonspecific laboratory markers).
III- Control group: 20 cases (healthy newborns).
All of our cases were subjected to careful history taking (personal, antenatal, natal and postnatal) to catch up any risk factor for neonatal sepsis either fetal, maternal or delivery.
Full clinical examination to all cases was followed for early detection of neonatal sepsis including cardiac, respiratory, neurological, GIT, and general or systemic manifestations that suspect sepsis.
Also laboratory investigations including CBC (total leucocytic counts, neutrophil counts, I/T ratio and platelets counts), blood culture, CRP and α1-AGP were done for either confirmed or suspected cases( two reading of suspected cases on admission and after 48 hours later for α1-AGP ).
The results of the study were:
There were statistically significant differences between confirmed and control groups regarding birth weight and there were non significant differences between suspected and either confirmed or control groups. Regarding gestational age there were statistically significant differences between control and suspected groups and ________________________________________there were non significant differences between the confirmed group and either control or suspected groups although all groups were full terms.
Regarding the sex there was no statistical difference between the three groups.
Regarding the risk factors of developing neonatal sepsis there were non significant difference between the confirmed and suspected groups regarding; PROM or maternal fever as maternal risk factors for neonatal sepsis. There were non significant differences between confirmed and suspected groups regarding; MSAF, primigravida vs. multigravida, maternal preeclampsia or maternal APH. Also the results were non significant for either mode of delivery (CS vs. ND), twin pregnancy, maternal gestational DM, ETT, chorioamnionitis, obstructed labor, circulage, maternal age, recurrent abortion or prenatal care. But regarding socioeconomic level there were statistically significant differences between control and confirmed groups and there were non significant differences between suspected and either control or confirmed groups.
The results of clinical picture in this study showed that neurological signs (convulsion, lethargy, hypotonia and bulging anterior fontanel) showed non significant differences between the studied groups. Regarding skin presentations (mottling, petechiae or sclerema) there were non significant differences between the studied groups. Hypoglycemia was seen in (2cases) in confirmed sepsis
________________________________________ (6.67% of cases) and (2 cases) in suspected sepsis (13.33% of cases).
The other clinical picture either respiratory (apnea, tachypnia, cyanosis or grunting), cardiac (bradycardia, tachycardia, delayed capillary refill >3 second or shock), gastrointestinal manifestation (jaundice, vomiting or abdominal distension), our study showed non significant differences between the studied groups regarding all of these symptoms and signs.
In our study on clinical evaluation, the most frequent symptoms in confirmed group were fever followed by poor feeding, tachypnea and then jaundice, moulting followed by tachycardia, abdominal distention, lethargy and vomiting. The most frequent symptoms in suspected group were fever, poor feeding followed by jaundice and tachypnia followed by vomiting, tachycardia, abdominal distention, lethargy and moulting.
In our study the prevalence of different organisms causing septicemia for confirmed cases with positive blood culture were E coli (8 cases) followed by klebsiella cases (7 cases) and S. aureus (6 cases) followed by pseudomonas (4 cases) and for staph epidermidis , strept species (2 cases) for each and only (1 case) enterobacter. The mortality was higher in neonates whose blood cultures were positive for E coli followed by S. aureus, pseudomonas and klebsiella.
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In our study the laboratory data for the patients’ showed that there was significant decrease in platelets counts in confirmed and suspected groups less than control group and significant increase in ESR, I/T ratio and electrolytes disturbances in confirmed and suspected groups more than control group. Otherwise there was a non significant differences between either confirmed, suspected or control groups regarding other parameters (Hb, TLC and Polymorph).
Regarding serum electrolytes; abnormalities ( hypocalcaemia, hypo or hypernatremia, hypo or hyperkalemia) were seen in 16 cases in confirmed group representing 53.33% and in 5 cases in suspected group representing 33.33%. There was no statistical significant difference between both groups regarding electrolytes disturbances.
The CRP mean value for the confirmed group was 40.88± 37.97 and that for the suspected group was 22.73±20.27 and that for control group was 5.32±2.9; meaning that confirmed and suspected groups of sepsis had significantly higher levels of CRP compared to control group while there was non significant difference between confirmed and suspected groups.
There was a non significant relationship between positive CRP and death in confirmed and suspected groups.
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In our study at a higher level of CRP= > 12.2mg/dl (as the best cut off value as a marker for diagnosis of EOS) the results showed high specificity and modest sensitivity.
In the current study the predictive characteristics of CRP (>6 mg/dl) (based on previously reported cutoff values) accuracy was slightly higher in suspected group (77.1%) than confirmed group (69.2%).
The relation between 1st reading α1-AGP and CRP and the diagnosis of EOS showed that parallel accuracy (80%) of both but higher odds ratio (27.8) in α1-AGP than in CRP (16).
In our study α1-AGP mean value was 122.8±66.1 for the confirmed group and 49.9±25.76 for the suspected group and 25.5±16.49 for control group, and the results showed that confirmed group had significantly higher levels of α1-AGP compared to control and suspected groups while there was non significant difference between control and suspected groups.
In the current study in the suspected group we collected two samples for α1-AGP 1st on suspicion of sepsis and the 2nd after 48 hours for all patients, the mean value for the 1st sample was 49.9±25.76 and for the 2nd sample (after 48 hours) was 88.13±29.13 and there was highly significant increase in the mean values for α1-AGP in 2nd sample (after 48 hours) more than the 1st sample (on suspicion).
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In the current study the predictive characteristics of α1-AGP (> 52 mg/dl) (1st reading) (based on previously reported cutoff values). Results showed slightly higher accuracy in the confirmed group (78.5%) than in the suspected group (74.3%).
In this study at a lower level of α1-AGP = > 39mg/dl as best cutoff value (first reading) as marker for EOS (confirmed/suspected) showed that it had a high sensitivity and specificity as a marker for EOS prediction.
In our study at a higher level of α1-AGP = >64 mg/dl (as the best cutoff value first reading) as a marker of EOS showed that it had a high sensitivity and specificity as a marker for EOS.
And at a lower level of α1-AGP = > 39mg/dl (as best cutoff value first reading) as a marker for EOS prediction in suspected group, the reported statistical outcomes showed that it had high specificity with low sensitivity. So, single test of α1-AGP is of limited value in the early diagnosis of neonatal sepsis. So, serial measurements will be needed.
In the current study there was significant negative relationship between α1-AGP and each of birth weight and platelet count and there was significant positive relationship between α1-AGP with I/T ratio, ESR and CRP.
In those who are died and those who are alive babies α1-AGP mean value was high in those who are died compared to those who ________________________________________are alive babies. There was highly positive significant relationship between levels of α1-AGP in those who are died and those who are alive babies in confirmed group but there was non significant difference between its levels in suspected and control groups (regarding 1st reading).
Regarding 2nd reading of α1-AGP in those who are died and those who are alive babies in the suspected group, there was positive significant relationship between the levels of α1-AGP in those who are died compared to those who are alive babies in suspected group.
At higher levels of α1-AGP and CRP as the best cutoff values, ROC curve analysis showed that α1-AGP is better marker than CRP in prediction of mortality among confirmed and suspected cases of EOS ( the more area under the curve the better the test).
In this study regarding 1st reading of α1-AGP there was non significant relationship between positive α1-AGP and morality in confirmed and suspected groups.
Regarding 2nd reading of α1-AGP in suspected group there was non significant relationship between positive α1-AGP 2nd reading and morality.
from this study we can conclude that α1-AGP is a good predictive marker for detection of EOS compared to CRP.