RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS(IN BLOCK LETTERS) / DR VENUGOPAL B L
POST-GRADUATE IN PAEDIATRICS,
DEPARTMENT OF PAEDIATRICS,
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE,
MYSORE-570001
2. / NAME OF THE INSTITUTION / MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE
MYSORE
3. / COURSE OF STUDY AND SUBJECT / M.D (PAEDIATRICS)
4. / DATE OF ADMISSION TO COURSE AND DATE OF
COMMENCEMENT OF COURSE / 30-04-2010
03-05-2010
5. / TITLE OF TOPIC / STUDY OF SURVIVAL OF VERY LOW BIRTH WEIGHT INFANTS (<1500 GRAMS ) ADMITTED TO OUTBORN NICU AND INBORN NICU IN CHELUVAMBHA HOSPITAL AT DISCHARGE AND RELEVANCE OF PERINATAL FACTORS
6. BRIEF RESUME OF THE INTENDED WORK
6.1 Need for the study
There is no indicator in human biology which tells us so much about the past events and future trajectory of life , as the weight of the newborn at birth8.The WHO defines very low birth weight as birth weight < 1500 grams at birth irrespective of gestational age. VLBW infants constitute 4-7% of all livebirth in INDIA .The survival rate of vlbw infants worldwide ranges between 43% in developing countries such as Jamaica 9 to more than 90% in developed countries such as Netherlands9 with an average about 73 % and in INDIA it is about 63%.
Survival of vlbw infants is directly associated with birth weight and inversely associated with illness severity5. It is reported that 60-80 % of all neonatal mortality and morbidity is due to vlbw 3. The survival rate of lower birth weight infant is reported to have increased from 10% to 50-60%10.Care of the newborn with vlbw continues to remain a challenge to paediatricians . These babies are at more risk of development of neonatal complications and its long term sequel. Resuscitation is required in more than 30% vlbw babies. These newborns need to be managed at NICU2 .
Medical advances in NICU coupled with program to regionalizing perinatal care have improved survival of vlbw7.The survival of vlbw admitted to nicu has substantially improved over years Doubts remain about the risk factors which accompany vlbw deliveries and which may be critical in determining proportion of survivors4 . The prognosis depends not only on birth weight and gestational age but also on perinatal factors and physiological condition of infants 11
Implementation of neonatal intensive care , use of mechanical ventilation and exogenous surfactant has been reported to improve the outcome especially for extremely low birth weight infants10.The survival to hospital discharge of vlbw infants has been well documented in developed countries with an increasing survival trend ,especially in extremely low birth weight( elbw) infants4 The survival and outcome of vlbw vary from hospital to hospital and from country to country regarding the quality of antenatal , intrapartum and neonatal care.
The factors affecting the survival of vlbw are different in level 2 and level 3 nicu Adverse outcome and hence less percentage of survival of vlbw outborn nicu is due to lack of adequate specialist medical support , insufficient staffing , equipment in nicu , inadequate stabilization and delay in commencing assisted ventilation or administration of surfactant. In addition transport to a tertiary care itself could adversely affect infants , the adverse association being great in vlbw.6
In cheluvamba hospital there are about 10000 deliveries per year and around 2500 admissions in inborn nicu ,1500 admissions in outborn nicu, out of which 3-4 % are vlbw infants.The present study aimed to analyze the various maternal , foetal/neonatal , laboratory parameters, on survival of vlbw infants in outborn and inborn NICU upto discharge.
6.2 Review of Literature
1.Care of the newborn , 17th edn, Meharban singh, page no.234 describes the Importance of birth weight as the most important factor in survival of vlbw infants.(1)
2. Daynia E Ballot*1, Tobias F Chirwa2 and Peter A Cooper1, has done a retrospective review of 474 vlbw infants admitted within 24 hrs of birth between 1 july 2006 to 30 june 2007, to nicu in johansburg, south Africa. Overall survival was 70.5 % survival of infants below 1001 gms birth weight was 34.9% compared to 85.8% for those between 1001 & 1500 gms at birth. The main determinant of survival was birth weight , other predictors of survival were gender, birth before arrival to hospital , necrotizing enterocolitis, hypotension ,use of nasal cpap. With conclusion that survival can be improved especially in infants < 1000 gms birth weight . resources need to be allocated to preventing the birth of vlbw babies outside hospital, early neonatal resuscitation, provision for nasal cpap and prevention of NEC, BMC Pediatrics 2010, 10:30
3. Illan arad et al, department of neonatology and center for safety and quality , Israel Neonatal outcome ( mortality, severe intraventricular haemmorhage, periventricular leukomalacia,broncho pulmonary dysplasia and intact survival) of inborn and out born extremely low birth weight infants accounting for sociodemographic , obstetric and perinatal variables.They compared 97 elbw infants delivered between year 200-2004 in a hospital providing nicu. Elbw outborn infants may share an out come comparable with that of inborn infants if adequate perinatal care is provided. , IMAJ 2008 10: 457-461.
4. Zeitlin et al ..Using a common protocol this study finds large differences in very preterm mortality and neurological and respiratory morbidity between European regions. doi 10.1542/peds.2007 pg no.1620
5.Basus et al .Division of neonatology, department of pediatrics institute of medical sciences, BHU Varanasi, india did a retrospective cohort of vlbw neonates admitted over 3 years study. Here the outcome measure was in hospital death . the survival rate was found to increase with the increase with the increase in birth weight and gestational age. Maternal antepartum haemorrhage, failure to administer steroid antenatally apgar score less than or equal to 5 at 1 min, apnoea, geststional age, septicemia and shock are the factor responsible for neonatal mortality , Singapore med journal 2008 49(7) 556 6. Erika et al , department of population health sciences, university of Wisconsin, Madison- A comparision of Wisconsin NICU with national data on out comes and practices..Here the newborns lung project did a unique regional cohort of vlbw children based on birth weight in Wisconsin and compared it with 16 level 3 nicu in state which found out that exogenous surfactant and antenatal steroid therapy to enhance lung maturity of preterm infants are thought to be responsible for much of the increased survival of of vlbw neonates. The decrease in mortality among vlbw infants was initially accompanied by an increase in early life morbidity such as IVH,BPD,& NEC.These morbidity have leveled off in recent years. WMJ 2008 november 107 ( 7) 320-326
7. suthida et al pediatric department , faculty of medicine thammasat university, survival and outcome of vlbw infants born in university hospital with level 2 nicu . did a retrospective longitudinal studywith objectives to determine survival , neonatal outcomes to hospital discharge and perinatal risks of death among vlbw infants . Survival rate of vlbw and elbw were 81% and 52% respectively. RDS was the major cause of death. Unfavorable outcome was documented in infants with birth wt < 750 gms. The morbidity and mortality in elbw infants remain high. Journal of med. Association Thailand vol 90, no.7 2007,
8.K.K.Roy et al in 2006 did a retrospective study on 92 pateints of preterm labour who delivered babies weighing <1500 grams . The maternal demographic profile , causes of preterm labour, treatment profile and delivery outcome were recorded. Similarly, the immediate neonatal morbidity and mortality were recorded in our case file. Both these data of maternal and neonatal profile were pooled and analysed. A total of 92 mothers in preterm labour at 26 to 34 weeks were admitted and subsequently delivered 70 VLBW babies (<1500 gms) and 36 ELBW babies (<1000 gms) including 8 pairs of twins and 3 triplets pregnancies. Majority of the patients (93.4%) were booked. Amongst the various high risk factors for preterm labour, anaemia during pregnancy (32.6%), bacterial vaginosis (26%), gestational hypertension (18.4%) and pervious history of preterm labour (18.4%) were common associations. Calcium channel blocker (Depin) tocolysis was effective in postponing labour from 48 hours to more than 2 weeks. The cesarean section rate was very high (67.3%) in our study. The commoner neonatal complications in both VLBW and ELBW babies were RDS, neonatal jaundice and sepsis. Features of IUGR were seen in both the groups (22.8% in VLBW and 22.2% in ELBW babies). The neonatal mortality rate till discharge was 15.7% in VLBW group and 33.3% in ELBW group. The morality rate was highest in 26 to 30 weeks gestation babies and in babies weighing <800 gms. Antenatal profile of preterm labour in our series showed a number of high risk factors. The identification of common high risk factors is important for appropriate prenatal care. A better neonatal survival rate was possible due to timely intervention, appropriate management and NICU care facility available in our tertiary care centre. Indian J Pediatrics 2006; 73 (8) : 669-673
9. Li-Yin Chien,et al in 1996-1997 did study that compared inborn and outborn preterm infants to findout whether outborn status is associated with higher mortality and mortality, after adjustment for perinatal risk.Outborn and inborn infants had significantly different gestational ages,perinatal risks, 5 minute apgar,delivery type,small for gestational age.outborn infants were at higher risk of death, grade 3 or 4 IVH, PDA, RDS, .Outborn infants were less matured and more ill than inborn infants at NICU admission.
6.3 Objectives of Study
1.To study the survival to hospital discharge of vlbw infants admitted in outborn and inborn nicu in cheluvamba hospital
2.To study the sociodemographic , obstetric and neonatal variables affecting survival of vlbw infants
3. To study the cut off level of birth weight in relation to chances of survival.
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7.MATERIALS AND METHODS
7.1 Source of Data
Very low birth weight infants i.e, <1500 gms infants admitted to outborn and inborn nicu at Cheluvamba Hospital attached to Mysore Medical College and Research Institute
7.2 Method Of Collection of Data
Sample size:
All very low birth weight infants(1500 grams) admitted to inborn and outborn nicu of cheluvambha hospital from 1/12/2010 to 30/03/2012
Sampling Method: All occurances
Inclusion Criteria:
All liveborn infants with birth weight <1500 gms irrespective of gestational age admitted in outborn and inborn NICU of cheluvamba hospital. Within in 24 hours of birth.
Exclusion Criteria:
1. Presence of lethal congenital anomalies.
2. Death within 12 hrs of life
Method of study:
The Descriptive and exploratory study of all very low birth weight infants admitted to outborn and inborn NICU of cheluvamba hospital , MMC & RI Mysore .
Data collection:
All inborn vlbw neonates admitted to NICU level 3 and outborn vlbw neonates admitted to nicu level 2 will be included in study.The infants will be followed upto discharge from hospital . The data collected will be entered onto a proforma, and entered to Microsoft access database. The factors considered will be:
1.Socio demographic variables: maternal age , education, socioeconomic status.
2.Obstetric variables: number of pregnancies, live birth, type of conception, type of delivery,single or multiple gestation, pregnancy complications(placental abruption, toxemia, prom,antenatal steroids,
3.Neonatal variables: the babies weight(weighed in a electronic scale), which will be classified as appropriate for gestational age , small for gestational age, large for gestational age, using form developed by kay j .l seton medical center,Austin., apgar score,the presence of respiratory distress, duration of oxygen therapy , pneumothorax,,neonatal hyperbilirubinemia, phototherapy,exchange transfusion,patent ductus arteriosus, necrotizing enterocolitis, intraventricular haemorrhage, periventricular leukomalacia,hypotension,infection,and causative organism blood result, retinopathy of prematurity, duration of hospital stay and final outcome i,.e, survival at discharge.
Details of NICU management, indications, duration, type of ventilator support and surfactant therapy,babies will managed according to unit polices at that time.
Statistical method used:
. All the following statistical methods (1.Multinominal logistic regression,2.Descriptive statistics,3.Contigency table analysis,4.Independent sample ‘t’ test) )shall be carried out through the SPSS for windows(version 18.0).The p value<0.05 shall be taken as statistically significant.
7.3 Does the study require any investigation/intervention to be conducted on patients/ humans/animals
NO
7.4 Has ethical clearance been obtained from your institution in case of 7.3 ?
Yes( copy attached)
8. REFERENCES:
1. Italian Collaborative Group on Preterm Delivery*Prenatal and postnatal factors affecting short-term survival of very low birth weight infants , Eur J Pediatr (1988) 147: 468-471
2.Krishna usha,Daftary Shirish.pregnancy at risk-current concepts,4th edition 2001;507
3.Robert L.Goldberg, the management of preterm labour.H igh risk pregnancy series- an experts view. Obstet gynaecol 2002; 100: 1020-1034
4.Suthida et al, Survival and outcome of very low birth weight infants born in a university hospital with level 2 nicu,j med assoc thai 2007 ; 90(7); 1323-9
5.Basu S, Rathorep,Bhatia B D , predictors of mortality in very low birth weight neonates in India , Singapore med journal 2008 49(7): 556
6.Illan Arad et al ,neonatal outcome of inborn and outborn extremely low birth weight infants: relevance of perinatal factors,IMAJ vol-10: june 2008
7.Zeitlin et al, differences in rates and short term outcome of live births before 32 weeks of gestation in Europe in 2003:Results from the MOSAIC cohort ,paediatrics 2008;121:e936-e944
8.Singh Meharban, disorders of weight and gestation ch 17 ,care of the newborn 7th edition New Delhi sagar publications, april 2010,page 234-250
9.Daynia e ballot,Tobias f Chirwa and Peter A Cooper, determinants of survival of in very low birth weight neonates in a public sector hospital in Johannesburg , BMC Pediatrics 2010, 10:30
10. Rogowsk JA, Horbar, J.D. Staiger D.O. Indirect vs direct hospital quality indicators for very low birth weight infants. JAMA 2004; 291 (2) : 202-209.
11. Tarnow-Mordi W, Ogston S, Wilkinson AR, et al. Predicting death from initial disease severity in very low birthweight infants: a method for comparing the performance of neonatal units. BMJ 1990; 300:1611-4
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9.SIGNATURE OF THE CANDIATE:
DR VENUGOPAL B L
10. REMARKS OF THE GUIDE:
11.NAME AND DESIGNATION OF
11.1 Guide: Dr KRISHNAMURTHY. B M.D , D.C.H