RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE – II

Proforma for Registration of Subjects for Dissertation

1. / NAME OF THE CANDIDATE AND ADDRESS / : / DR. RASHMI . D
No. 1648 , HAL 3rd STAGE, JEEVAN BHIMA NAGAR MAIN ROAD, OPPOSITE MIRANDA SCHOOL, BANGALORE-560008
2. / NAME OF THE INSTITUTION / : / BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE.
3. / COURSE OF STUDY AND SUBJECT / : / M.D. IN PEDIATRICS.
4. / DATE OF ADMISSION TO THE COURSE / : / 03-05-2010
5. / TITLE OF THE TOPIC / : / A PROSPECTIVE STUDY TO EVALUATE EARLY PREDICTORS OF MORTALITY IN VERY LOW BIRTH WEIGHT NEONATES AND TO COMPARE WITH DIFFERENT MORTALITY RISK SCORES.

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

Very low birth weight neonates constitute approximately 4-7% of all live births. These neonates need a major share of time, effort and resources for their care. Despite this attention, mortality is high in this group, contributing to as much as 30% of early neonatal deaths. Survival of these neonates is inversely associated with their birth weight, gestation and illness severity.1

But these factors are insufficient to explain the large variations in neonatal mortality among various neonatal intensive care units. The interaction of illness severity and physiological alterations complicate the management policies, the appropriateness of which determines the neonatal outcome. Hence, there has been an effort in recent times to define various physiological and laboratory parameters, which would be predictive of neonatal mortality in the very low birth weight neonates which includes scores like Clinical Risk Index for Babies (CRIB) and Score for Neonatal Acute Physiology – Perinatal Extension (SNAP-PE). CRIB includes the following parameters like birthweight, gestational age, congenital malformation, base excess and FiO2. CRIB II includes 4 parameters of birthweight, gestational age, temperature and base excess. SNAP II includes mean blood pressure, temperature, pO2, pH, multiple seizures and urine output. SNAP-PE II in addition to parameters in SNAP II includes Apgar score, birth weight and small for gestational age. These scores give weightage for certain parameters and are not just an attempt to predict outcome for an individual but describe the clinical condition so that some adjustment between outcomes in a population can be made. But these scores require regular review and updating as techniques and interventions change and as new parameters come into play.

Hence the present study aims to analyze the influence of various early predictors of mortality like maternal risk factors (eg., pregnancy induced hypertension, eclampsia, maternal anemia, heart disease, significant obstetric problems, maternal age and weight gain), fetal factors (eg., birth weight, gestational age, Apgar score at 1, 5 and 10 minutes, intrauterine growth status, need for and duration of resuscitation at birth, presence of congenital malformations, multiple gestation, antenatal steroid prophylaxis, physiologic factors like heart rate, respiratory rate, blood pressure, capillary filling time, temperature, urine output, presence of seizures, apnea and interventions like need for ventilation and requirement of oxygen) and laboratory parameters (complete blood picture, serum electrolytes, blood glucose and arterial blood gas analysis) on the mortality in very low birth weight neonates1 and to compare them with existing risk scores like CRIB, CRIB II, SNAP II and SNAP-PE II.

6.2  REVIEW OF LITERATURE:

Tarun Gera et al in their study concluded that the factors significantly associated with early neonatal mortality in the very low birth weight neonates included birth weight, gestational age, low Apgar scores, need for assisted ventilation at birth, need for supplementation oxygen and mechanical ventilation in the first 24 hours and also presence of shock, hypoxia and acidosis. The factors associated with late neonatal mortality were birth asphyxia and gestational age only.1

Richard H B de Courcy – Wheeler et al in their study concluded that CRIB scoring system was better for the prediction of mortality, morbidity and was not good for the prediction of length of stay but was a better predictor of mortality than birth weight alone. CRIB, gestation and birthweight were all significant univariate predictors of mortality.2

Maliheh Kadivar et al in their study concluded that SNAP-PE II and Apgar score at 5 min were found significant for predicting the neonatal mortality and that SNAP-PE II had the best performance. Factors like birth weight, age at admission to the NICU, sex and duration of stay in the NICU had no significant influence on mortality.3

Mariani Schlabendorff Zardo et al in their study concluded that all neonatal mortality scores like CRIB, SNAP II, SNAP-PE II, SNAP-PE had a better performance than birth weight alone, in predicting mortality risk and also that SNAP-PE II was found to be superior to birth weight, SNAP and SNAP II when considering all patients and they also demonstrated the importance of PE included in SNAP-PE II, which takes into account birth weight, SGA classification, Apgar score at fifth minute as factors that contribute to an increase in mortality risk.4

Gagliardi L et al in their study concluded that CRIB II and SNAP-PE II did not fully estimate the risk of death because, in addition to the parameters used in the score several other variables like antenatal steroid prophylaxis, caesarean section, singleton birth, Apgar score greater than or equal to 7 at 5 minutes, not being SGA and not having any congenital anomaly were significantly associated with better survival in very low birth weight neonates.5

Olaf Dammann et al in their study concluded that SNAP-II and SNAPPE-II predicted death at the population level, not at the individual level, among infants born at very low gestational ages and also that the illness severity scores intended to predict death among these neonates appeared to be applicable to the narrow gestational age range of 23-27 weeks.6

6.3  AIMS AND OBJECTIVES OF THE STUDY:

·  To evaluate early predictors of mortality in very low birth weight neonates

·  To compare these predictors with CRIB, CRIB II, SNAP II and SNAP-PE II scores.

7  MATERIALS AND METHODS:

7.1 SOURCE OF DATA:- Study subjects will include 300 inborn neonates weighing less than 1.5 kg admitted to Neonatal Intensive Care Unit (NICU) in Vani Vilas Children’s Hospital and Bowring and Lady Curzon Hospitals during the study period October 2010 to September 2012.

7.2 METHOD OF COLLECTION OF DATA: -

Definition of Study Subjects- A study subjects of 300 inborn neonates who fulfill the inclusion criteria will be included in the study.

7.3 INCLUSION CRITERIA:-

·  Neonates with birth weight more than 500 grams and less than or equal to 1500 grams.

7.4 EXCLUSION CRITERIA:-

·  Neonates with birth weight of more than 1500 grams and less than 500 grams.

·  Neonates with gestational age of less than 22 weeks.

·  Presence of major congenital malformations.

·  Death within 12 hours of life.

After obtaining written informed consent from parents, relevant information will be recorded in a predesigned proforma. These neonates will be assessed for early predictors of mortality and also for different mortality risk scores like CRIB, CRIB II, SNAP II and SNAP-PE II.

7.5 Does the study require any investigation or interventions to be conducted on patients or other human beings or animals ? If so please describe briefly? YES

Investigations as per the study protocol like complete blood count, arterial blood gas analysis, blood glucose and serum electrolytes will be carried out. No additional investigation will be carried out for the study.

7.6 Has the ethical committee clearance been obtained for this study from your Institution ?

7.7 STATISTICAL ANALYSIS:-

This is a hospital based prospective study .

Statistical methods to be used for the analysis of the data includes univariate analysis, Student’s t test, z test, Multiple linear regression, Chi square test, Mann-Whitney U-Wilcoxon test and Receiver operating characteristic (ROC) curves to compare different tests.

8. LIST OF REFERENCES:

1.  Gera T, Ramji S. Early Predictors of Mortality in Very Low Birth Weight Neonates. Indian Pediatrics 2001; 38: 596-602.

2.  Courcy-Wheeler de BHR, Wolfe ADC, Fitzgerald A, Spencer M, Goodman SDJ, Gamsu RH. Use of the CRIB (clinical risk index for babies) score in prediction of neonatal mortality and morbidity. Archives of Disease in Childhood 1995; 73: 32-36.

3.  Kadivar M, Sagheb S, Bavafa F, Moghadam L, Eshrati B. Neonatal Mortality Risk Assessment in a Neonatal Intensive Care Unit(NICU). Iran J Ped. Dec 2007; 17: 325-331.

4.  Zardo SM, Procianoy SR. Comparison between different mortality risk scores in a neonatal intensive care unit. Revista de Saude Publica 2003; 37: 591-596.

5.  Gagliardi L, Cavazza A, Brunelli A, Battaglioli M, Merazzi D, Tandoi F et al. Assessing mortality risk in very low birthweight infants: a comparison of CRIB, CRIB II, and SNAPPE-II. Arch Dis Child Fetal Neonatal 2004; 89: 419-422.

6.  Dammann O, Shah B, Naples M, Bednarek F, Zupancic J, Allred NE et al. SNAP- II and SNAPPE-II as predictors of death among infants born before the 28th week of gestation. Inter-institutional variations. Pediatrics 2009; 124: 1001-1006.

7.  Singh M. Examination of the Baby. In : Meharban Singh. Care of the Newborn. 7th ed. New Delhi: Sagar publication; 2010: 118-120.

8.  Marlow N. Organisation and evaluation of perinatal care. In : Roberton’s. Textbook of neonatology. 4th ed. Edinburgh: Elsevier publication; 2005: 43-62.

9. / SIGNATURE OF THE CANDIDATE / : / DR. RASHMI .D
10. / REMARKS OF THE GUIDE / : / Mortality remains high in very low birth weight neonates, despite recent advances in perinatal care. Hence a study on early predictors of mortality in these neonates is the need of the time.
11. / NAME & DESIGNATION OF GUIDE
11.1 / GUIDE / : / DR GANGADHAR B BELAVADI,
PROFESSOR AND HOD, DEPARTMENT OF PEDIATRICS,
BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE.
11.2 / SIGNATURE / :
11.3 / CO-GUIDE / :
11.4 / SIGNATURE / :
11.5 / HEAD OF THE DEPARTMENT / : / DR. GANGADHAR B. BELAVADI,
PROF. AND HOD,
DEPARTMENT OF PEDIATRICS,
VANIVILAS HOSPITAL,
BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE, BANGALORE.
11.6 / SIGNATURE / :
12.1 / REMARKS OF THE CHAIRMAN & PRINCIPAL / :
12.2 /

SIGNATURE

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