ANNEXURE 1
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
/NAME OF THE CANDIDATE AND ADDRESS
/ Dr. BABY SANA KROOM NO G2,WOMENS HOSTEL,
MVJ MEDICAL COLLEGE & RESEARCH HOSPITAL, HOSKOTE,
BANGALORE-562114.
2.
/NAME OF THE INSTITUTION
/ M.V.J MEDICAL COLLEGE AND RESEARCH HOSPITAL3.
/COURSE OF THE STUDY AND SUBJECT
/MD.PAEDIATRICS
4.
/DATE OF ADMISSION TO COURSE
/31-5-2012
5.
/TITLE OF TOPIC
/ STUDY OF GLYCEMIC STATUS OF LOW BIRTH WEIGHT BABIES IN THE FIRST 3 DAYS IN EXCLUSIVELY BREAST FED BABIES IN A RURAL HOSPITAL6. BRIEF RESUME OF INTENDED WORK
6.1. NEED FOR STUDY:-
Neonatal hypoglycemia is one of the most common problems seen in neonatal intensive care units. The operational threshold for hypoglycemia is defined as “that concentration of plasma or whole blood glucose at which the clinician should consider intervention, based on the evidence currently available in the literature.” Most workers now agree that a true blood glucose level of 40mg per 100ml (irrespective of period of gestation), if associated with symptoms of hypoglycemia or if confirmed on repeat analysis in asymptomatic babies, is indicative of hypoglycemia. (1) There are many risk factors for hypoglycemia in neonate, such as low birth weight and preterm, where screening is recommended.
Glucose is a very important substrate of metabolism especially in the brain, severe and prolonged neonatal hypoglycemia is associated with a risk of long term neurodevelopmental sequelae. So the assessment of blood glucose in high risk group and treatment of hypoglycemia is important. A glucose level <40 mg/dL at any time in any newborn requires follow-up glucose measurement to document normal values. The incidence of hypoglycemia has been found to occur commonly in small-for-gestational-age babies and preterm. Low birth weight babies may be preterm or small-for date babies. Small-for-date babies may be born at term or preterm. They weigh less than 10th percentile for the gestational age.
Term appropriate weight for gestational age babies are able to generate ketone bodies from the fatty acids released from adipose tissue as their body response to low blood glucose concentration while preterm babies are less able to do the same. Their inability to mobilize alternative fuels suggests that blood glucose monitoring should be carried out from birth and may be discontinued only if euglycaemic levels are maintained.
In a baby friendly hospital where exclusive breast feeding is the norm if the baby is fit to suck and swallow as per the gestation age, these low birth weight babies whose requirement of glucose from feeds is very much essential, the hypothesis is till breast feeding is adequately established these babies may be susceptible to hypoglycemia which may be symptomatic or asymptomatic.
This study is being undertaken to know the incidence, variable clinical presentation at the onset of hypoglycemia in low birth weight neonate who are exclusively breast fed from birth and the time to establish the euglycemic status while return back to exclusive breast feed.
REVIEW OF LITERATURE:-
There are various studies conducted about blood glucose level in low birth weight neonates.
Study done by Deb K Pal found that neonatal hypoglycemia is more common in a developing countries, 41% newborn infants had mild (less than 2.6 mmol/l or 46.85mg/dl) and 11% moderate hypoglycaemia. Significant independent risk factors for moderate hypoglycaemia included post maturity , birth weight under 2.5 kg(32%), small head size, infant haemoglobin >210g/l, and raised maternal thyroid stimulating hormone (TSH). Feeding delay increased the risk of hypoglycaemia at age 12–24 hours. (2)
Harris D et al in a study found that Hypoglycemia is common amongst babies recommended for routine blood glucose screening. We found no evidence that screening protocols should differ in different at risk groups, but multiple risk factors may increase severity. The significance of these hypoglycemic episodes for long-term outcome remains undetermined. (3)
Tam E W, et al in a study found that Hypoglycemia (glucose <46 mg/dL) in the first 24 hours after birth was detected in 16% of the cohort. Adjusting for potential confounders of early perinatal distress and need for resuscitation, neonatal hypoglycemia was associated with a 3.72-fold increased odds of corticospinal tract injury (P=.047). Hypoglycemia was also associated with 4.82-fold increased odds of 1-point worsened neuromotor score (P=.038) and a 15-point lower cognitive and language score on the Bayley Scales of Infant Development (P=.015). (4)
Udani V,et al study found that Neonatal hypoglycemia is the most common etiology of remote symptomatic infantile onset epilepsy. LBW, poor neonatal feeding and cesarean delivery are significant clinical correlates (5)
Duvanel CB et al in astudy found that Recurrent episodes of hypoglycemia were strongly correlated with persistent neurodevelopmental and physical growth deficits until 5 years of age. Recurrent hypoglycemia also was a more predictable factor for long-term effects than the severity of a single hypoglycemic episode. Therefore repetitive blood glucose monitoring and rapid treatment even for mild hypoglycemia are recommended for small-for-gestational-age infants in the neonatal period. (6)
Study done by Dorina Rodica Burdan, Valentin Botiu, Doina Teodorescu suggested that newborns with low body weight are at the greater risk of hypoglycemia. From all neonates with neonatal hypoglycemia, the neonates at term represent 45.53%, the preterm infants represent 52.84%, and the post term infants represent 1.63%. The preterm infants are at greater risk of neonatal hypoglycemia in this study. In this study, the most frequent pathology associated with neonatal hypoglycemia was: perinatal hypoxia – 40.31%, neonatal hypothermia - 31.45%, respiratory distress - 40.31%, sepsis - 12.09%, neonatal shock - 9.67% and polycythemia - 8.87%.(7)
AIMS AND OBJECTIVES OF THE STUDY:-
1. To study the incidence of hypoglycemia in low birth weight neonate on exclusive breast feed
2. To study the symptomatology at the time of presentation of hypoglycemia
3. To evaluate the time of occurrence, duration of glucose support and time to return to full breast feed again.
4. To identify maternal and neonatal risk factors for the same
7. MATERIAL AND METHODS:-
7.1. DESIGN
It is a prospective study of blood glucose in low birth weight infants on exclusive breast feeds conducted at MVJ medical college and research hospital Hoskote, Bangalore, from October 2012 to September 2014. The sample size is around 100 neonates.
7.2. SOURCE OF DATA
Low birth weight neonates on exclusive breast feeds born from October 2012 to September 2014 will form the subjects of the study
7.3. METHODS OF COLLECTION OF DATA
Neonates delivered by normal or cesarean section who were found low birth weight were taken up for collecting blood samples at 0,3, 6, 12,24,48 and 72 hours. Study neonates will be on exclusive breast feeds if fit enough(suck, swallow coordination) for the same. Samples will be collected by heel prick (capillary blood). The glucose level was measured using glucometer. All hypoglycemia will be confirmed by random blood sugar from lab. Neonates detected to have hypoglycemia during this study will be managed according to the standard protocol for monitoring and managing the hypoglycemia.
The age of onset of hypoglycemia along with presenting symptoms will be documented. The neonates will be weaned back to breast feed based on maintaining of the glycemic status and time to euglycemic status on exclusive breast feed will be noted.
7.4. INCLUSION CRITERIA
· All neonates defined as LBW(1500-2500 gm)
· On exclusive breast feed from birth
7.5. EXCLUSION CRITERIA
· Neonatal asphyxia
· Sepsis
· Babies given IV fluids for other purpose
· Factors not allowing for breast feeding eg Severe cleft palate etc
7.6. INVESTIGATIONS
Random blood sugar by- 1) Glucometer
2) Glucose oxidase method
7.7. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION
Yes ethical clearance obtained (Attached)
REFERENCES AND CITATIONS
1. Meharban singh. Metabolic disorders. In: Care of the newborn. Meherban Singh Ed, 5 edn, 1999,Sagar publications, N Delhi p.366-370
2. Deb K Pal, Dharma S Manandhar, Sujan Rajbhandari, John M Land, Navin Patel,Anthony M de L Costello. Neonatal hypoglycaemia in Nepal 1. Prevalence and risk factors. Arch Dis Child Fetal Neonatal Ed. 2000; 82:F46–F51.
3. Harris DL, Weston PJ, Harding JE. Incidence of Neonatal Hypoglycemia in Babies Identified as at Risk. J Pediatr. 2012 Jun P 23.
4. Tam EW, Haeusslein LA, Bonifacio SL, Glass HC, Rogers EE et al; Hypoglycemia is associated with increased risk for brain injury and adverse neurodevelopmental outcome in neonates at risk for encephalopathy J Pediatr. 2012 Jul;161(1):88-93. Epub 2012 Feb 4.
5. Udani V, Munot P, Ursekar M, Gupta S.Neonatal hypoglycemic brain - injury a common cause of infantile onset remote symptomatic epilepsy. Indian Pediatr. 2009 Feb;46(2):127-32.
6. 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):492-8.
7. Dorina Rodica Burdan, Valentin Botiu, Doina Teodorescu. Neonatal hypoglycemia, the incidence of the risk factors in Salvator Vuia Obstetrics-Gynacology Hospital, ARAD. TMJ. 2009; 59(1):77-80.
8. SIGNATURE OF THE CANDIDATE:
10. NAME AND DESIGNATION OF THE GUIDE: Dr.Ravichander,
Professor & HOD,
Department of Paediatrics,
M.V.J Medical College & RH
10.1 REMARKS OF THE GUIDE :
Hypoglycemia is a common problem in Low birth weight babies. But the magnitude, risks and time to establish euglycemic status in exclusive breast fed babies have not been studied adequately. Hence this topic is a good subject for dissertation by this PG student. Recommended
10.2 SIGNATURE :
11 HEAD OF THE DEPARTMENT Dr.Ravichander,
Professor & HOD,
Department of Paediatrics,
M.V.J Medical College & RH
11.1 SIGNATURE
12. PRINCIPAL :
13. REMARKS :
13.1 SIGNATURE :