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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE,
KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
Name of Candidate
Dr. PRASHANTH. R
and
S/O RUDRAPPA. D,
Address
#215, 15TH WARD,
(in block letters)
OPP. BASAVESHWARA TEMPLE,
THALI ROAD,
ANEKAL,
BANGALORE. PIN-562106
2.
JJM Medical College,
Name of Institution
Davangere,
Karnataka. PIN-577004
3.
Course of study and subject
Post-Graduate,
MD in Pathology
4.
Date of admission to course
5.
Title of the Topic:
29.5.2012
“CLINICO-HEMATOLOGICAL PROFILE OF
NEONATAL ANEMIA”
1
6.
Brief resume of the intended work
6.1 Need for the study
Anemia is a disorder characterized by an abnormally low red cell mass; in clinical practice,
“hemoglobin concentration” is assumed to reflect the circulating red cell mass, and an
abnormally low hemoglobin concentration defines the anemic state.1 The expected ranges of
hematocrit, hemoglobin concentration, and erythrocyte count undergo considerable changes
during fetal life and after birth.2 Neonatal anemia is defined by a hemoglobin or hematocrit
concentration of greater than two standard deviations below the mean for postnatal age.3 The
causes of neonatal anemia are blood loss during prenatal, perinatal and postnatal period,
intrinsic red blood cell destruction and decreased red cell production. Diagnosis of neonatal
anemia in most studies is considered when hemoglobin is below 13 g/dl.4,5,6,7
Anemia in the newborn period is often a complex problem owing to the normal variation in
hematological parameters, and also because, in no other period of life, anemia is known to
occur due to such varied causes.5 This necessitates the need to take up the study on neonatal
anemia.
6.2 Review of Literature
The newborn period can be characterized as one of transition, during which the neonate
leaves the relative hypoxic in-utero environment and emerges into an altered physiological
setting. To effectively make the transition, the modification of several organ systems must
take place. The hematologic system of the newly born exemplifies this process.
Hematopoiesis in the fetus and neonate is in a constant state of flux and evolution as the
newborn adapts to a new milieu. Review of the data on the extensive research undertaken to
define neonatal hematologic norms suggests the extreme variation with advancing age in what
is defined as normal, thereby making the identification of abnormal problematic.3 The mean
hemoglobin concentration of cord blood has been reported in various studies to range from
15.7 g/dl to 17.9 g/dl. Approximately 95% of all values fall between 13.7 g/dl and 20.1 g/dl.5
The differential diagnosis of non-physiologic neonatal anemia is extensive and includes not
only many of the causes of anemia seen in older patients, but also many unique to the fetus
and newborn associated with pregnancy, labor and delivery. Classifying anemia into
categories of RBC loss, including hemorrhage and hemolysis, and inadequate erythrocyte
production provides a useful framework for the evaluation, diagnosis, and treatment of the
anemic neonate.8
2
A classification according to the cause of anemia is as follows1,3,4,9,10:
I. Secondary to decreased production:
1. Congenital red cell aplasia (Diamond-Blackfan anemia)
2. Infection- acquired (bacterial sepsis)
- congenital (rubella)
3. Nutritional deficiencies (e.g., Iron deficiency)
4. Congenital leukemia
5. Physiologic anemia or anemia of prematurity
II. Secondary to increased destruction
1. Immune hemolytic anemia
-Rh, ABO or minor group incompatibility
-Maternal autoimmune hemolytic anemia
-Drug induced hemolytic anemia
2. Infection- acquired (bacterial sepsis)
- congenital (rubella, disseminated herpes)
3. Vitamin E deficiency
4. Red cell membrane disorders
-Hereditary spherocytosis
-Hereditary elliptocytosis
-Other rare disorders (e.g., hereditary stomatocytosis)
5. Thalassemia syndromes
-α thalassemia
-gamma thalassemia
6. Unstable hemoglobinopathies
III.
Secondary to blood loss
1. Occult hemorrhage prior to birth or during delivery
-Feto-maternal
-Twin-to-twin
-Feto-placental
2. Obstetric accidents, malformations of placenta or cord
3. Internal hemorrhage
-Intracranial
-Ruptured liver/spleen
4. Iatrogenic blood loss
3
The most common causes of anemia present at birth are hemorrhage and hemolysis
secondary to isoimmunization. After 24 hours of age, external or internal hemorrhage and
non-immune hemolytic disorders are more common.4
The establishment of an accurate diagnosis is essential to directing the appropriate
therapeutic interventions. Given the diverse etiology of neonatal anemia, a systematic
approach to diagnosis is often required as follows3,4,10:
1. History:
-
Appropriate data vary with the patient’s age, but often include maternal antenatal,
obstetric and delivery history, the estimated gestational age at birth, the chronologic
age, the infant’s diet, and details of any previous anemia, blood loss, transfusions,
medications, and illnesses, as well as the family history of anemia, jaundice,
splenectomy.
2. Physical examination:
-
The physical examination should evaluate the general health, growth and
development, skin for pallor, jaundice. Identification of any dysmorphic features,
abnormal masses, or skin lesions can aid the diagnosis. The patient also should be
assessed for hepatosplenomegaly, cardiovascular function, and lymphadenopathy.
3. Laboratory investigations:
-
It is beneficial to proceed with investigation in a stepwise manner. The first step
should be to establish a diagnosis of anemia by hemoglobin or hematocrit
estimation. The initial laboratory evaluation includes a complete blood count
(CBC) with RBC indexes, a reticulocyte count, and evaluation of the peripheral
blood smear. The results of the preliminary tests, combined with information from
the history and physical examination, should dictate the need for further tests, such
as determining maternal and neonatal blood grouping, analysis of serum bilirubin,
direct Coombs test, sepsis work up (CRP, cultures or titres) and other relevant
investigations (osmotic fragility test, Hb electrophoresis, specific enzyme assays,
bone marrow aspiration, etc.).
4
6.3 Objectives of the study
1. To study the hematological profile of neonatal anemia which includes hematological
parameters obtained by automated cell counter, reticulocyte count, blood grouping
(ABO and Rh), direct Coombs test and peripheral blood smear examination.
2. To study the clinical features in various causes of neonatal anemia.
7.
Materials and methods
7.1 Source of data
This study will be undertaken on neonates referred to the Department of Pathology, JJM
Medical College, Davangere for investigations, during the period July 2012 to June 2014.
(Two years’ study)
7.2 Method of collection of data (including sampling procedure, if any)
Case samples will be selected consecutively as and when they present with anemia. All
cases will be subjected to detailed clinical examination. Venous blood sample will be
collected under aseptic precautions in vials containing approximately 1.5 mg/ml EDTA
anticoagulant and subjected to investigations for hematological parameters- hemoglobin,
hematocrit, total and differential WBC count, RBC indices, platelet count, RDW, MPV, in
automated cell counter (Sysmex XT-1800i 5-part analyzer), reticulocyte count, blood
grouping, direct Coombs test, peripheral blood smear examination after staining with
Leishman’s stain using the standard protocol. Other investigations (like Hb electrophoresis,
biochemical investigations like serum total, direct and indirect bilirubin, osmotic fragility,
bone marrow aspirate examination, etc.) will be done only if indicated.
C-reactive protein, Hematologic scoring system of Rodwell and Tudehope11,12 will be
assessed in cases of anemia associated with neonatal sepsis.
5
Statistical analysis:
Pattern of anemia will be presented as frequency & percentage proportions. Average levels
of different hematological parameters will be compared within various causes of neonatal
anemia using Analysis of variance (ANOVA) & Student t- test. Categorical data will be
analyzed by Chi-square test.
Sample size: 100
Inclusion criteria:

Neonates (age– 28 days and less) clinically diagnosed as anemia with
hemoglobin level of 13 g/dl or less.
Exclusion criteria:

Neonates with severe bleeding manifestations;
and

Neonates with hemoglobin level more than 13 g/dl.
7.3 Does the study require any investigations or interventions to be conducted on
patients or other humans or animals? If so, please describe briefly.
Yes
Venous blood sample for investigations like hemoglobin, hematocrit, reticulocyte count,
direct Coombs test, RBC indices, blood grouping, peripheral blood smear and other relevant
investigations only when indicated.
Bone marrow examination only if clinically indicated.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes.
6
8.
List of references
1. Blanchette VS, Zipursky A. Assessment of anemia in newborn infants. Symposium on
perinatal hematology. Clin Perinatol 1984; 11(2): 489-510.
2. Christensen RD, Ohis RK. Anemias unique to the newborn period. In: Greer JP,
Foerster J, Rodgers GM, Paraskevas F, Glader B, Arber DA et.al., editors. Wintrobe’s
clinical hematology, Vol. 1, 12th ed. Philadelphia: Lippincott Williams and Wilkins;
2009. p. 1247-1260.
3. Bizzaro MJ, Colson E, Ehrenkranz RA. Differential diagnosis and management of
anemia in the newborn. Pediatr Clin N Am 2004; 51: 1087-1107.
4. Kulkarni ML. Common neonatal problems. In: Manual of neonatology. New Delhi:
Jaypee; 2000. p. 363-368.
5. Lokeshwar MR, Singhal T, Shah N. Anemia in the newborn. Symposium on
hematology-II (Neonatal Hematology). Ind J Pediatr 2003; 70: 893-902.
6. Kumara S, Gupta AK, Dadhich JP. Anemia in neonates. In: Gupte S, editor. R A P
Neonatology – 2, Spl. Vol. 5. New Delhi: Jaypee; 2000. p. 212-229.
7. Kumari S, Saxena A, Monga D, Malik A, Kabra M, Kurray RM. Significance of cord
problems at birth. Ind Pediatr 1992; 29: 301-303.
8. Gallagher PG. Hematology of the newborn. In: Young NS, Gerson SL, High KA.
Clinical hematology. Philadelphia: Elsevier Mosby; 2006. p. 911-919.
9. Christou HA. Anemia. In: Cloherty JP, Eichenwald EC, Hansen AR, Stark AR,
editors. Manual of neonatal care. 7th ed. Philadelphia: Lippinott Williams & Wilkins;
2012. p. 563-571.
10. Luchtman-Jones L, Wilson DB. The blood and hematopoietic system, part 1,
Hematologic problems in the fetus and neonate. In: Martin RJ, Fanaroff AA, Walsh
MC, editors. Fanaroff and Martin’s neonatal-perinatal medicine. Diseases of the fetus
and infant. Vol. 2. 9th ed. Missouri: Elsevier Mosby; 2011. p. 1303-1360.
11. Benitz WE. Adjunct laboratory tests in the diagnosis of early-onset neonatal sepsis.
Clin Perinatol 2010; 37(2): 421-438.
12. Basu S, Guruprasad, Narang A, Garewal G. Diagnosis of sepsis in the high risk
neonate using a hematologic scoring system. Ind J of Hemat & Blood Transf 1999;
17(2): 32-34.
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9.
Signature of Candidate
10.
Remarks of the Guide
11.
Name and Designation of the
Guide (in block letters).
11.1 Guide
Neonatal anemia is a complex problem and
interpretation of laboratory findings is crucial. This
study will be useful for institution of appropriate
therapy.
DR. S. S. HIREMATH, MD.
PROFESSOR & HOD,
DEPARTMENT OF PATHOLOGY,
JJM MEDICAL COLLEGE.
DAVANGERE-577004
11.2 Signature
_
11.3 Co-Guide (if any)
11.4 Signature
11.5 Head Of the Department
DR. S.S.HIREMATH, MD.
PROFESSOR AND HOD,
DEPARTMENT OF PATHOLOGY,
JJM MEDICAL COLLEGE.
DAVANGERE-577004.
11.6 Signature
12.
12.1 Remarks of the Chairman & Principal
12.2 Signature
8