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Evaluation of TOPS score as predictor for outcome in sick newborns

The first 28 days of life the neonatal period is the most vulnerable time for a child’s survival. The global NMR, IMR and U5MR was 18, 12 and 10 respectively in 2017 with about 1 million newborns dying on the first day and close to 1 million dying within the next six days. The daily risk of mortality in the first 4 weeks of life is ~30fold higher than the post-neonatal period, that is, from 1 month to 59 months of age. Almost two third of the total neonatal deaths are within first week of life. At the same time the Millennium Development goal (MDG)-4 on child mortality for India aims for a two third reduction in IMR from 1990 level of 84/1000 live births to 28/1000 live births by 2015. Hence it is important to have a feasible tool to predict neonatal mortality. Noninstitutional births constitute a significant proportion of total births in developing country like India and still ABSTRACT


INTRODUCTION
The first 28 days of life -the neonatal period -is the most vulnerable time for a child's survival. The global NMR, IMR and U5MR was 18, 12 and 10 respectively in 2017 with about 1 million newborns dying on the first day and close to 1 million dying within the next six days. The daily risk of mortality in the first 4 weeks of life is ~30fold higher than the post-neonatal period, that is, from 1 month to 59 months of age. 1 Almost two third of the total neonatal deaths are within first week of life. At the same time the Millennium Development goal (MDG)-4 on child mortality for India aims for a two third reduction in IMR from 1990 level of 84/1000 live births to 28/1000 live births by 2015. Hence it is important to have a feasible tool to predict neonatal mortality. Noninstitutional births constitute a significant proportion of total births in developing country like India and still many deliveries are conducted at home specifically in rural area. Though institutional delivery and in-utero transport of newborn is safest but unfortunately preterm delivery and perinatal illness cannot be always anticipated resulting in continued need of transfer of these babies after delivery. There is considerable risk of deterioration of critically-ill patients during transfer, either due to primary illness, complications of treatment or due to the transfer process itself. These babies are often critically ill and outcome is also dependent on effectiveness of transport system. Prematurity, asphyxia and sepsis are the most common causes of neonatal mortality in developing countries. 2 Most of neonatal transports are self-transport without any pre-treatment stabilization or care during transport. Many of these newborns thus transported are presented with life threatening complications like irreversible shock, seizures, respiratory distress on admission to higher centre. The overall mortality of referred neonates has remained high in India, and a significant number of these deaths can be avoided by promotion of institutional deliveries, early identification and appropriate pre referral stabilization, care of newborns during transport, and provision of adequate equipment, skilled workforce, and monitoring facilities during transport of neonates.
It is preferable to have organized transport than selftransport. Once the decision of transporting a newborn has been taken then assessment of newborn, stabilization and care during transport becomes important so a newborn can reach a referral facility in stable condition to improve intact survival. Multiple scoring systems have been developed using many parameters observed at admission, during hospital stay and at discharge to predict outcomes. However, it must be remembered that these systems provide generalizations about groups and that they do not allow the bedside clinician to predict outcome for an individual patient.
The desirable properties of neonatal scores have been described as including: - Ease of use;  Applicability early in course of hospitalization;  Ability to reproducibly predict mortality, specific morbidities, or cost for various categories of neonates;  Usefulness for all groups of neonates to be described. 3 Body temperature, airway and breathing (Oxygenation), perfusion and sugar (hypoglycaemia) need to be addressed adequately before and during transport. TOPS, a simplified assessment of neonatal acute physiology gives a good prediction of mortality in these neonates.

Need for study
TOPS score has been proven as a tool to assess parameters of clinical profile and predictor of mortality in neonates. Few studies have been conducted regarding TOPS score in transported neonates but there is no study on TOPS score in assessing extramural vs intramural neonates and outcome in them so my study is on clinical profile and mortality outcome in extramural vs intramural neonates at teaching tertiary care hospital at NICU.

Scoring systems
Scoring systems involve using appropriately weighted demographic, physiological, and clinical data collected on the infant to calculate a score that quantifies its morbidity.
Clinical Risk Index for Babies (CRIB) score: was published by Tarnow-Mordi et al, to predict mortality for infants born at less than 32 weeks gestation at birth taking into account birth weight, gestational age, maximum and minimum fraction of inspired oxygen (FiO2) and maximum base deficit during the first 12 hours, as well as presence of congenital malformations. The advantage was ease of data collection but assessment over the first 12 hours of life, made it less susceptible to treatment effects than some other scores. 4 CRIB II, an improved version of CRIB adding admission temperature and base excess to predict mortality. 5 Score for neonatal acute physiology (SNAP) 6 SNAP, the principal alternative to CRIB, was developed in 1990, based on 28 items collected over the first 24 hours of life from a variety of sources including every body system and selected blood test results. The variables were weighted according to expert opinion, with a score of 0, 1, 3, or 5 assigned to each variable. The original cohort was also used to extend SNAP to form the SNAP-PE score (score for neonatal acute physiology perinatal extension) by adding birth weight, small for gestational age (weight <5th centile for gestation), and low Apgar score at five minutes. Although the SNAP score assesses many body systems, and is able to predict death well, it is much more difficult to collect.

SNAP-II and SNAPPE-II 7
Because of the difficulty of data collection for the SNAP and SNAP-PE scores, the original authors have recently produced simpler versions using data from 30 North American units. Changes included shortening the period of data collection to 12 hours and reducing the number of variables to six (mean blood pressure, lowest temperature, PO2/FIO2 ratio, serum pH, multiple seizures, and urine output). These factors were assessed as having the strongest statistical association with mortality.
National therapeutic intervention scoring system (NTISS) 8 NTISS was published in 1992 and was derived by an expert panel as a modification of the adult intensive care International Journal of Contemporary Pediatrics | June 2020 | Vol 7 | Issue 6 Page 1251 score, therapeutic intervention scoring system. NTISS is unusual as it is based on the treatments received by an infant rather than measuring patho-physiological factors. As treatment depends on policy and practice in units, it can vary greatly, and it is not possible to compare units using this type of adjustment.
Mortality Index for Neonatal Transport (MINT) score: Broughton SJ, Berry A, Jacobe S et al, included neonates >72 hours of age and a 7-variable model (Apgar score at 1 minute, birthweight, presence of a congenital anomaly, and infant's age, pH, arterial partial pressure of oxygen, and heart rate at the time of the call) to generate the MINT (Mortality Index for Neonatal Transportation) score, which gave areas under ROC curves of 0.80 for both neonatal and perinatal death. 9 The availability of ABG and documentation of APGAR scores for all cases is difficult to be obtained in government hospitals, hence there is a need for simpler yet reliable score for prediction of mortality in a transported neonate.

TOPS score
Neonatal physiology is adversely affected based on temperature, oxygen saturation, skin perfusion and blood sugar (TOPS) which have shown to predict the mortality in transported neonates, which was first described by Mathur NB et al. 10 A study by Mathur NB, Arora D. in their prospective study included 175 neonates >1000 gm. weight shown that All the TOPS variables had significant correlation with fatality on univariate analysis. Fatality was 100% when all the four TOPS variables were deranged. The sensitivity, specificity, positive and negative predictive values of derangements of two or more TOPS parameters in predicting mortality were 81.6%, 77.39%, 65.3% and 89%, respectively. The total correct classification rate for TOPS was 81.7%, while that for SNAP II (Score for Neonatal Physiology) was 83.4%.Thus TOPS has an equally good prediction for mortality as SNAP II and can be used as a simple and useful method of assessment of risk of fatality that can be assessed immediately, at admission.
Objective of this study was to the utility of TOPS score for predicting mortality in sick neonates.

METHODS
Study site the study was a hospital-based study conducted at NICU, Dept. of Pediatrics, GMERS Medical College, Gotri, Vadodara, Gujarat, India. Study duration for one year from 1st May 2017 to 30th April 2018. Study population of all admitted neonates aged <28 days at NICU including intramural and extramural admissions. Study design is a hospital based, prospective, observational study. Sample size for the purpose of sample size calculation, the clinical profile was defined according to the TOPS score in two categories: neonate with TOPS score=0 were defined as good TOPS score and neonates with TOPS score>1 were defined as poor TOPS score. Thus, study objective was to compare the proportion of neonates with good TOPS score belonging to the intra and extramural group. The method of sample size calculation was Fleiss with continuity correction using Open Epi software.

Inclusion criteria
All extramural and intramural neonates (<28 days) requiring admission in NICU.


Neonates having life threatening congenital anomaly.  Neonates having acute surgical emergencies.  Refusal to give informed written consent by parents.
Methdology a prospective observational study was conducted at NICU, Dept. of pediatrics, GMERS Medical College, Gotri, Vadodara, Gujarat, India. Permission was obtained from Institutional Ethical Committee and Scientific Review Board. All subjects <28 days of age who satisfied the inclusion criteria were included in study after informed written consent by parents and were subjected to detailed clinical history and physical examination. The neonatal case proforma was used to record information. Gestational age was noted from records and reconfirmed with modified Ballard score if <7 days of age. Weight of all the cases were taken on digital weighing machine with minimum 0.001 kg accuracy as weight on admission.
The variables assessed under TOPS score on arrival for all subjects were: Temperature by digital thermometer in axilla, Oxygen by spO2 monitoring (pulse oxymeter), Perfusion by capillary refilling time(CRT) on mid sternum by applying blanching pressure and RBS with reagent strip and low reading <45 mg/dl confirmed by serum sample at laboratory.
The altered parameters were: Hypothermia defined as temperature <36.5 degree Celsius, Hypoxia was diagnosed when SpO2 recorded <90%, poor perfusion recorded as prolonged CRT >/= 3 sec and Hypoglycaemia as RBS <45 mg/dl and confirmed by serum sample. All affected neonates were given treatment as per NICU protocol and outcome was assessed in terms of mortality or discharge using TOPS score.

Data summarization
TOPS score was assessed on admission. Treatment measures were initiated as per NICU protocol and close monitoring was done till discharge / mortality. The TOPS score was then used to predict mortality and analysed the predictive value of the score as well as risk association of individual parameters with outcome.

Statistical methods
The data was analysed for their association with immediate outcome by applying chi square test as applicable and p<0.05 was considered statistically significant. Variables that were found to be significant on chi square test were further analysed using bi variant logistic regression analysis for their possible independent association with mortality using statistical software SPSS. Nagelkerke R. Square was taken into consideration.

RESULTS
The     As all cases, 4.1% had hypoglycaemia (RBS<45mg/dl), which were equally distributed in both groups. In intramural group hypoglycaemia was observed in cases having septicaemia with ELBW and due to improper feeding. Fewer cases of hypoglycaemia were observed in extramural group due to transportation of newborns with infusion/IV fluids/bolus of dextrose before transport (Table 1).
Among 46.9% cases who were hypothermic on admission succumbed. X 2 value is 21.48 and it is statistically significant at 5% level (p < 0.05). Mortality observed in hypoxic cases was 51.7%. X 2 value is 14.89 and it is statistically significant at 5% level (p < 0.05). Mortality rate in cases presenting with prolonged CRT was significantly high (87.5%). X 2 value is 34.87 and it is statistically significant at 5% level (p < 0.05).
Thus, results suggest independent association with hypoxia, hypothermia and poor pefusion and mortality. Highest association of poor outcome was found with poor perfusion followed by hypoxia and hypothermia. (Table  2). Table 3 TOPS profile of cases. Here, for each parameter of TOPS score, score 2 is given for normal and score 1 is given for altered one. Hence, TOPS score ranges from 4-8. In the study, none of the cases had all altered parameters i.e. score 4. 8.16% cases had 3 altered parameters i.e. score 5 with 100% mortality outcome.20.41% cases had 2 altered parameters, score 6 with 65% mortality association. Altered single parameter, score 7 was observed in 34.7% cases with out of which 12% neonates succumbed and all cases having no altered parameter i.e. score 8 were discharged. This suggests the risk association of multiple parameters affection with increased mortality rate.   Hypoglycaemia is common in newborns born and referred from outside due to poor pre referral management, nil by mouth etc. In this study hypoglycaemia in newborns was recorded due to clinical reasons such as Respiratory distress Syndrome (RDS), sepsis, asphyxia etc. Only 2 newborns referred from outside presented with hypoglycaemia in this study out of which one expired. That case was due to severe birth asphyxia and sepsis. Though hypoglycaemia was not found to have statistically significant association with mortality in this study, it was found to have independent risk relation with mortality as observed by Sehgal  In this study, 100% of newborns with 3 altered TOPS parameters (score 5) succumbed, while mortality in newborns with 2 altered parameters i.e. score 6 was 65%. Cases with single altered parameter i.e. score 7 had 12% mortality and all cases having none altered parameter i.e. score 8 were discharged. Thus, it was observed that mortality rate increased with increasing no. of altered TOPS parameters.

CONCLUSION
TOPS score confirms its fair ability to predict mortality. All parameters are physiologically important and each parameter carries an independent risk associated with mortality. It is important to note that multiple parameters affected increases the risk of neonatal mortality.
Limitations of the study were confounding factors like birth weight, gestational age and associated illness which were not compared while comparing TOPS score and mortality. So, further studies are needed to identify strength of individual parameters of TOPS score in relation to mortality to increase its objectivity and use as a prognostic indicator.

Recommendations
 To use TOPS score in all NICU  To establish regionalization of perinatal and neonatal care to allow for immediate care of newborn and early and complete treatment of perinatal morbidities.