RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

6. BRIEF RESUME OF THE INTENDED WORK:

6. 1 NEED FOR STUDY

Neonatal hypoglycemia is one of the most common metabolic problems seen in newborns. The reported incidence of hypoglycemia varies with its definition but, it has been estimated to occur in approximately 16% of large for gestational age infants and 15% of small for gestational age babies.1 The incidence of neonatal hypoglycemia was 8.1% when hypoglycemia was defined as blood glucose level < 1.7mmol/lt (30.6 mg/dl) and 20.6% when it was defined as blood glucose level <2.2 mmol/lt (39.6 mg/dl). 2

Early diagnosis and treatment of neonatal hypoglycemia is an important aspect as many studies showed that recurrent episodes of hypoglycemia correlate with persistent neurodevelopment and physical growth deficit until 5 yrs of age.3

Normal blood glucose levels are maintained by gluconeogenesis. Gluconeogenesisis impaired in small for gestational age infants, large for gestational age infants, infants of diabetic mothers and preterm infants.So, early detection of hypoglycemia insuch infants at risk is of utmost value to prevent the sequelae.4, 5, 6

The objectiveof the presentstudy is to assessthe normal capillary blood glucose levels in neonates using a glucometer and the various factors influencing it.

6.2 REVIEW OF LITERATURE: -

The term hypoglycemia refers to a reduction in the glucose concentration of circulating blood.7Hypoglycemia isdefinedas a glucose concentration less than one standard deviation below the mean value.8

The rangeof concentrations of glucose obtained in a study of a population of babies isdependent upon many factors including the presence of predisposingfactors,the physiological status of the baby at the time of sampling,whether whole blood, serum, orplasma is used for the analysis, the time between sampling and analysis, the methods used to prevent glycolysis and also the technique of measurementused (whether Dextrostix, Reflolux, glucoseoxidase technique, etc). 9

Srinivasan etal measured plasma glucose concentrations in healthy term babies at varying ages and recommended that hypoglycemia should be defined as a plasma glucose concentration of <2.2 mmol/l(39.6mg/dl) in the first 24 hours after birth and <2.6 mmol/l (46.8mg/dl) thereafter.10

Heck and Erenbergrecommendedthat hypoglycemiabe defined as <1.7 mmol/ (30.6mg/dl) in the first day after birth and <2.2 mmol/l (39.6mg/dl) thereafter.11

A surveyconducted inAustralia to define and screen neonatal hypoglycemia using a bedside glucometer showed a wide range of blood glucose levels ranging from1.1 mmol/lt (19.8mg/dl) to 3mmol/lt (54mg/dl). 12

Astudy by Eva Hoseth etal to find the blood glucose levels in a population of healthy breastfed term Danish infants of appropriate size for gestational age found that blood glucose levels in newborns within first 24 hrs of delivery were significantly lower ranging from 1.4mmol/lt (25.2 mg/dl) to 4.9 mmol/lt (88.2mg/dl) and those after 24 hrs ranged from 2.1mmol/lt (37.8mg/dl) to 5.3 mmol/lt (95.4 mg/dl). 13

A cross sectional study was conducted by J.M.Hawdon etal on 156 term infants and 62 preterm infants to establish normal range of blood glucose levels. It showed that blood glucose levels range was 1.5mmol/lt (27mg/dl) - 12.2mmol/lt (219.6mg/dl) for preterms and 1.5mmol/lt (27mg/dl)-6.2mmol/lt (111.6mg/dl) for term infants.14

There have been very few studies comparing maternal and newborn blood glucose levels. A study which was conductedin Turkey compared maternal blood glucose estimated 15-30 mins before or at time of birth with the babies blood glucose levels measured immediately at birth. However, there was no influence of maternal blood glucose levels on the neonatal blood glucose levels.15

A study conducted by Dorina Rodica etal showed that the incidence of hypoglycemia was 60.48% in cases of vaginal deliveries to that of 39.52 % in cases of caesarian deliveries. Of all neonates with neonatal hypoglycemia, the neonates at term represent 45.33%, the preterm infants represent 52.84% of the infants studied, and the post term infants represent 1.63% of the total infants. The preterm infants were at greater risk of neonatal hypoglycemia in their study.16

However, a study to evaluate the plasma glucose levels in normal term Indian infants who were appropriate size for gestational age and exclusively breastfed, revealed no significant variation in plasma glucose levels between 3 and 72 hours of age. Further, it was found that parity, mode of delivery, and time since the last feed did not affect plasma glucose.17

6.3 OBJECTIVES OF THE STUDY :

1. To assess theglucose levels in newborns born at K.V.G.MedicalCollege & Hospital, Sullia.

2. To assess the influence of maternal glucose level taken within half an hour or at time of delivery on babies glucose levels.

3. To assess the influence of gestational age on glucose levels.

4. To assess the influence of mode of delivery on glucose levels.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA :

All the newborn babies born at K.V.GMedicalCollegeand Hospital,Sullia,between December2009 and December2010.

7.2 METHOD OF COLLECTION OF DATA :

Informed consent will be taken from mothers of newborns enrolled in the study. The neonatal blood glucose levels will be measured usinga glucometer by heel prick method at 0,3,6 and 24 hours. A single maternal blood glucose level will be measured, using a glucometer, by finger prick half an hour before or at time of delivery. All the newborns will be exclusively breastfed as per the hospital policy. If hypoglycemia is detected in any of the newborns studied, confirmation will be done by glucose oxidase test in the laboratory.

All relevant data will be documented in a specially designed proforma with details such as gestational age, mode of delivery, glucose levels of the newborns at 0.3,6,24 hours and maternal glucose level taken with in halfan hourbefore or at time of delivery.

INCLUSION CRITERIA :

All the babies born at K.V.G.Medical College& Hospital,Sullia, irrespective of gestational age and weight for Age.

EXCLUSION CRITERIA:

Sick infants with congenital anomalies and chromosomal anomalies will be excluded from the study.

FOLLOW-UP: 3,6,24 hours of life.

FOLLOW-UP-PERIOD: 24 hours.

7.3Does the study require any investigation/intervention to be conducted on

Patients/humans/animals? If so, please describe briefly

Yes.After obtaining consent,taking all aseptic precautions, capillary blood will be collected from the newbornsby heel prick method and mothers by finger prick method.The concern regarding the hypoglycemia arises from the established risk of neurological damage after repeated and prolonged episodes of low circulating glucose concentrations.

7.4Has ethical clearance been obtained from your institution in case of 7.3 ?

-Yes (Copy enclosed).

8. REFERENCES :

1. Wilker RE. Hypoglycemia and Hyperglycemia. In: JohnP. Cloherty, Eric C. Eichenwald, Ann R. Stark.(Editors). Manual of Neonatal Care. Sixth edition. Wolters Kluwer. Philadelphia. 2008. p540-549.

2. Sexson WR. Incidence of neonatal hypoglycemia: A matter of definition. J Pediatr1984; 105:149–150.

3.Duvanel CB, Fawer CL, Cotting J, Hohlfeld P, Matthieu JM. Long-term effects of neonatal hypoglycemia on brain growth and psychomotor development in small-for-gestational-age preterm infants.J Pediatr 1999 Apr; 134(4):389-91.

4.Cornblath M, Schwartz R, Aynsley-Green A, et al. Hypoglycemia in infancy: the need for a rational definition (Ciba Foundation DiscussionMeeting). Pediatrics 1990; 85:834–7

5. Kalhan S, Parimi P. Gluconeogenesis in the fetus and neonate.Semin Perinatol 2000; 24:94-106.

6. Kramer MS, Platt RW, Wen SW and the Fetal/Infant HealthStudy Group of the Canadian Perinatal Surveillance System. A newand improved population-based Canadian reference for birth weightfor gestational age. Pediatrics 2001; 108: E 35.

7.Hartmann AF,Jaudon JC. Hypoglycaemia. J Pediatr 1937;11:1-36.

8. Cornblath M, Schwartz P. Disorders of carbohydrate metabolism in infancy. Philadelphia: WB Saunders, 1976.

9. Koh THHG, Eyre JA, Aynsley-Green A. Neonatal hypoglycemia: the controversy regarding definition. Arch Dis Child 1988; 63:1386–98.

10. Srinivasan G, Pildes RS, Cattamanchi G, Viora S, Lillien LD. Plasma glucose values in normal neonates: a new look. J Pediatr 1986; 109:114-7.

11.Heck LJ, Erenberg A. Serum glucose levels in term neonates during the first 48 hours of life. J Pediatr 1987; 110:119-22.

12.BonacruzGL, ArnoldJD,LeslieGI,WyndhamL,KoumantakisG. Survey of the definition and screening of neonatal hypoglycemia in Australia.Journal of Paediatrics and Child HealthJun2008;32 (4):299–301.

13. Hoseth E, Joergensen A, Ebbensen F. Blood glucose levels in a population of healthy breast fed term infants of appropriate size for gestational age. Arch Dis Child FetalNeonatal Ed 2000; 83:F117-19.

14.Hawdon JM, Ward Platt MP, Aynsley-Green A. Patterns of metabolic adaptation for preterm and term infants in the first neonatal week. Arch Dis Child 1992; 67:357–65.

15. Tanzer F, Yazar N, Yazar H, Icagasioglu D. Blood glucose levels and hypoglycemia in full term neonates during the first 48 hours of life. J Trop Pediatr1997; 42:58–60.

16. Dorina Rodica Burdan, Valentin Botiu, Doina Teodorescu. Neonatal hypoglycemia. The incidence of the risk factors in SalvatorVuiaObstetrics-GynecologyHospital, ARAD. TMJ 2009; 59(1): 77-80.

17.Diwakar KK, Sasidhar MV. Plasma glucose levels in term infants who are appropriate size for gestation and exclusively breast fed. Arch Dis Child Fetal Neonatal Ed 2002; 87

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