S. B KADAM ET AL
Quality of Survivals on Conservative Neonatal Care By S. B. Kadam, S. R. Daga, and A. S. Daga Institute of Child Health, and Department of Preventive and Social Medicine, Grant Medical College and J.J. Hospital, Bombay 400 008, India
Introduction
Last two decades have witnessed improvement in quantity as well as quality of survival among newborns. Thus, a yard-stick for judging the performance of a neonatal unit is not only improvement in the number who survive, but also the number of normal survivors. The problem of neurodevelopmentally handicapped survivors when considered from the socio-economic point of view is a tremendous burden on society. Therefore, intact survival is the most desirable outcome, particularly in developing countries where rehabilitation services for the handicapped individuals are far from satisfactory. The reported incidence of neurodevelopmental handicap (NDH) depends upon the type of assessment used, length of follow-up, quality of neonatal intensive care, the types of complications which occur, socio-economic development, and overall mothering skills. Long-term longitudinal studies alone can provide a true impact of a given biological insult since many overlapping and changing variables determine the outcome. However, this task is by no means easy. Identification of perinatal factors which are associated with poor outcome may help obstetricians and neonatologists in management so that NDH can be minised.
during September 1985 to December 1985 were prospectively followed up for a period of 1 year (Table 1). The hospital serves mainly the people from lower socio-economic group. The babies were assessed every 3 months according to a set protocol. Out of 220 babies discharged, 90 were lost to follow-up and three died. The remaining 127 could be followed up regularly. Presence of risk factors in them was noted (Table 2). Some babies had more than one risk factor. The list of risk factors considered is given in Appendix 1. TABLE 1
ICUN Roster (September-December 1985) No.
Admissions Deaths Discharges Patients followed up Deaths during follow-up Patients lost to follow-up Neurodevelopment handicaps Minor Major
267 47 220 127 3 90 13 5 8
%
17.6 82.4 59.1 2.3
40.9 10.2 3.9 63
Materials and Methods
High-risk babies discharged from the Intensive Care Unit for Newborns, J.J. Hospital, Bombay, Acknowledgements Authors (hank Mr J. C. Sharma from the Electronic Data Processing Department, Tata Institute of Social Sciences, Bombay, for his help and guidance. Correspondence: Dr S. R. Daga, 1/11 Staff Quarters, J J. Hospital, Bombay 400 008, India. 250
© Oxford University Press 1991
Follow-up protocol
The babies were examined every 3 months and their neurodevelopmental outcome was assessed under the following heads. 1. 2. 3. 4.
Neurological examination. Psychological assessment. Gross hearing. Gross vision and fundoscopy.
Journal of Tropical Pediatrics
Vol. 37
October 1991
Downloaded from http://tropej.oxfordjournals.org/ at University of Arizona on September 5, 2015
Summary Quantity as well as quality of survivals determine the performance of a neonatal centre. Our centre bas succeeded in improving survival with low cost technology without compromising the quality. Neurodevelopmental handicap was low on a 1-year follow-up. No baby had retinopatfay of prematurity or bearing deficit. Dropout rate has been high although comprising of mainly full-terra or near-term babies with mild perinatal asphyxia or mild respiratory distress or requiring instrumentation during delivery. Longer follow-up is desirable.
S. B. KADAM ET AL.
TABLE 2
Distribution of risk factors in 'Follow-up' group and 'Lost-to-follow-up' group No. of patients
High risk factor
Lost to follow-up group
68 56 15 25 57 38 5 4 5 44
43 53 8 11 41 25 2 1 3 34
4
3
Neurological examination was carried out as per the classic method of Paine and Oppe. Psychological assessment was done by a clinical psychologist without prior knowledge of the neonatal history using Bayley Scale of Infant Development 2 (BSID) between 9 and 12 months of age. Average Motor Development Index (MDI) and Psychomotor Developmental Index (PDI) were calculated for every baby. Gross hearing was tested clinically. Startle response, blinking of eyes, sudden changes in the activity with greater alertness were expected in response to sound. In a suspected case of hearing loss, brain stem auditory evoked response study was planned. Gross vision was tested in all patients. Babies with birth weight less than 1500 g or gestational age less than 32 weeks were subjected to fundoscopy to detect retinopathy of prematurity. (ROP). Neurodevelopment handicap (NDH) was defined as major neurological defect or an average MDI and PDI score < 80.2 Statistical analysis Results were analysed by binary regression method with NDH as a dependent variable (y) and 14 different risk factors as independent variables (
*
,
-
,
*
)
Variables and factors
Factor value
1. Socio-economic status Low socio-economic group Average socio-economic group
16.00 18.52
2. Significant antenatal history Present Absent
12.22 18.61
3. Gestational age Less than 37 weeks More than 37 weeks
22.06 10.17
4. Birth weight VLBW LBW Average
26.67 14.06 16.67
0.04
0.34
1.33
0.58
5. Relationship of gestational age to BW SGA AGA & LGA
6.67 19.59
6. Fetal distress Present Absent
29.82 5.71
7. Birth asphyxia-Apgar score at 1 min. Less than or equal to 5 6-10
Weighting factor
1.14
5.45
7.00 44.00 9.80
8. Birth asphyxia-Apgar score at 5 min. Less than or equal to 5 6-10
29.96 125.00 9.24
9. Neonatal seizures Present Absent
120.00 12.30
10. Assisted deliveries Present Absent
31.58 10.12
11. Respiratory distress Present Absent
31.81 8.43
12. Sepsis Present Absent
80.00 13.93
16.62
3.66
4.69
•
A factor value was calculated from the equation by regression coefficient to the constant term and then multiplying this by 100. The factor value represents probability of NDH for that risk factor. Each variable may explain different proportion of total variance, therefore weighting factor for each variable was calculated. It was equal to the percentage that the R2 of that variable represented in respect to the sum of the R2 values of all the variables (Tables 3 and 4). Total risk score was then calculated by multiJournal of Tropical Pediatrics
Vol. 37
October 1991
13. Hyperbilirubinaemia Present Absent 14. Apnoea more than 20 sec. Present Absent
6.25
21.94 150.00 12.12 8.83 25.00 16.26
251
Downloaded from http://tropej.oxfordjournals.org/ at University of Arizona on September 5, 2015
1. Prematurity 2. Birth weight—LBW —VLBW 3. Birth asphyxia 4. Fetal distress 5. Assisted deliveries 6. Neonatal seizures 7. Hyperbilirubinaemia 8. Sepsis 9. Respiratory distress 10. Apnoea more than 20 sec.
Follow-up group
TABLE 3
Factor values and weighting factors for the independent variables
S. B. KADAM ET AL.
TABLE 4
Risk prediction with different variables Predicted risk Test of significance
High
1. Socio-economic status Low Average
55 16
45 11
NS
2. Significant antenatal history Present Absent
22 49
19 37
NS
3. Gestational age equal and Less than 37 weeks More than 37 weeks
44 27
24 32
*
4. Birth weight Less than 1500 g 1500-2490 g 2500-and more
8 26 37
7 30 19
NS
5. Relation of birth weight to gestational age SGA SGA
16 55
14 42
NS
6. Foetal distress Present Absent
15 56
42 14
Weighting factor
Variables 1. 2. 3. 4. 5. 6. 7. 8. 9.
Birth asphyxia Apgar score at 5 min < 5 Hyperbilirubinaemia Neonatal seizures Birth asphyxia Apgar score at 1 min. < 5 Sepsis Fetal distress Respiratory distress Assisted deliveries Gestational age
29.96 21.94 16.62 7.00 6.25 5.45 4.69 3.66 1.33
TABLE 6
Risk prediction in followed-up group
7. Apgar Score (1 min.) 5 and less More than 5
0 71
25 31
*••
8. Apgar Score (5 min.) 5 and less More than 5
0 71
8 48
+4
9. Seizures Present Absent
0 71
5 51
*
10. Assisted deliveries Present Absent
7 64
31 25
11. Respiratory distress Present Absent
17 54
27 29
*
12. Sepsis Present Absent
0 71
5 51
•
13. Hyperbilirubinaemia Present Absent
0 71
4 52
*
14. Apnoea (20 sec. and more) Present Absent
2 69
2 54
NS
252
TABLE 5
Statistically significant variables in order of predicting weightage for NDH
Risk prediction Low High
Total score
Patients (no.)
13.39 and less 13.40 and more
71 56
Risk of NDH was predicted with each independent variable and tests of significance (either Chisquare or Z test) were applied to see whether risk prediction varies with presence or absence of 14 variables (Table 7). Independent variables having good weighting factor with statistically significant variance were considered predictors of risk for NDH. TABLE 7
Predicted and measured degree of neurodevelopmental handicap Actual neurodevelopmental outcome Predicted
risk
Minor NDH
Major NDH
Nil
Total
Low High
1 4
1 7
69 45
71 56
Total
5
8
114
127
Journal of Tropical Pediatrics
Vol. 37
October 1991
Downloaded from http://tropej.oxfordjournals.org/ at University of Arizona on September 5, 2015
Low
Risk factor
plying the weighting factors by the respective factor value for each variable and then adding these scores for all the 14 variables (Table 5). All the infants were grouped into high and low risk prediction by means of median of total risk score. Those infants who had total risk score more than 13.40 were considered as having high risk of prediction of NDH and those with score less than 13.39 were grouped into low risk of prediction of NDH (Table 6).
S B KADAM ET AL.
Journal of Tropical Pediatrics
Vol. 37
October 1991
care 7 is comparable with modern 'aggressive' care. However, it would have been desirable to have a longer follow-up. Reference 1. Paine RS. Neurological examination of infant and children. Pediat Clin N Am 1960; 7: 471-509. 2. Bayley N. Bayley Scales of infant development. New York: The Psychological Corporation, 1969.' 3. DeSouza SW, Richards B. Neurological sequelae in newborn babies after perinatal asphyxia. Arch Dis Childh 1978; 53: 564-9. 4. Saigal S. The outcome of VLBW—Past, present and future. Ind J Pediat. 1986; 53: 365-71. 5. Hilda K, RideT R. Neuropsychiatric sequelae of prematurity. J Am Med Ass; 161: 581-8. 6. Hilary S. Outcome of severe asphyxia. Arch Dis Childh 1976; 51: 712-16. 7. Daga SR, Daga AS. Mortality prevention potential of conservative neonatal care. J Trop Pediat 1986; 32: 183-7. Appendix 1
List of independent variables studied 1. Socio-economic status. 2. Significant antenatal history. 3. Gestational age. 4. Birth weight. 5. Relationship of GA to birth wt. 6. Birth asphyxia Apgar score at 1 min. 7. Birth asphyxia Apgar score at 5 min. 8. Fetal distress. 9. Assisted deliveries. 10. Respiratory distress. 11. Neonatal seizures. 12. Hyperbilirubinaemia. 13. Sepsis. 14. Apnoea more than 20 sec.
253
Downloaded from http://tropej.oxfordjournals.org/ at University of Arizona on September 5, 2015
Results and Discussion Many authors have studied the quality of survival. Unfortunately, most of these studies are unidirectional, involving one aspect of the quality of survival3 or just one risk factor.4"* Studying the impact of many high-risk factors on different aspects of neurodevelopmental outcome is necessary. Since, often more than one risk factors are present in a baby (Tables 3 and 4). The drop-out rate has been high in our study. Two factors are thought to be responsible. The hospital caters for the low income groups, the majority of whom are slum or pavement dwellers who frequently move and, hence, are difficult to trace on home-visits. Secondly, term and near-term babies with intraparum asphyxia or less severe neonatal problems such as transient tachypnoea of newborn formed a large proportion of these babies, admitted often for 'observation'. Follow-up was considered unnecessary by the parents since these babies were 'normal'. Asphyxia with and Apgar Score of less than 5 at 1 and 5 minutes, hyperbilirubinaemia, convulsions, sepsis, fetal distress, respiratory distress, assisted delivery and low gestational age have been found to be predictors of high risk for neurodevelopmental handicap. Out of 127 infants followed up, five (4 per cent) had minor NDH and eight (6 per cent) had major NDH. No baby developed ROP. It is difficult to compare this study with other studies since they have largely confined themselves to the influence of limited factors on the outcome. Besides, the ethnicity, socio-economic status, antenatal care, type of obstetric care and neonatal care have been radically different to make any reasonable comparison possible. Still it can be safely said that the outcome in respect to two commonest parameters studied, viz LBW/prematurity and asphyxia on 'conservative'
Quality of Survivals on Conservative Neonatal Care By S. B. Kadam, S. R. Daga, and A. S. Daga Institute of Child Health, and Department of Preventive and Social Medicine, Grant Medical College and J.J. Hospital, Bombay 400 008, India
Introduction
Last two decades have witnessed improvement in quantity as well as quality of survival among newborns. Thus, a yard-stick for judging the performance of a neonatal unit is not only improvement in the number who survive, but also the number of normal survivors. The problem of neurodevelopmentally handicapped survivors when considered from the socio-economic point of view is a tremendous burden on society. Therefore, intact survival is the most desirable outcome, particularly in developing countries where rehabilitation services for the handicapped individuals are far from satisfactory. The reported incidence of neurodevelopmental handicap (NDH) depends upon the type of assessment used, length of follow-up, quality of neonatal intensive care, the types of complications which occur, socio-economic development, and overall mothering skills. Long-term longitudinal studies alone can provide a true impact of a given biological insult since many overlapping and changing variables determine the outcome. However, this task is by no means easy. Identification of perinatal factors which are associated with poor outcome may help obstetricians and neonatologists in management so that NDH can be minised.
during September 1985 to December 1985 were prospectively followed up for a period of 1 year (Table 1). The hospital serves mainly the people from lower socio-economic group. The babies were assessed every 3 months according to a set protocol. Out of 220 babies discharged, 90 were lost to follow-up and three died. The remaining 127 could be followed up regularly. Presence of risk factors in them was noted (Table 2). Some babies had more than one risk factor. The list of risk factors considered is given in Appendix 1. TABLE 1
ICUN Roster (September-December 1985) No.
Admissions Deaths Discharges Patients followed up Deaths during follow-up Patients lost to follow-up Neurodevelopment handicaps Minor Major
267 47 220 127 3 90 13 5 8
%
17.6 82.4 59.1 2.3
40.9 10.2 3.9 63
Materials and Methods
High-risk babies discharged from the Intensive Care Unit for Newborns, J.J. Hospital, Bombay, Acknowledgements Authors (hank Mr J. C. Sharma from the Electronic Data Processing Department, Tata Institute of Social Sciences, Bombay, for his help and guidance. Correspondence: Dr S. R. Daga, 1/11 Staff Quarters, J J. Hospital, Bombay 400 008, India. 250
© Oxford University Press 1991
Follow-up protocol
The babies were examined every 3 months and their neurodevelopmental outcome was assessed under the following heads. 1. 2. 3. 4.
Neurological examination. Psychological assessment. Gross hearing. Gross vision and fundoscopy.
Journal of Tropical Pediatrics
Vol. 37
October 1991
Downloaded from http://tropej.oxfordjournals.org/ at University of Arizona on September 5, 2015
Summary Quantity as well as quality of survivals determine the performance of a neonatal centre. Our centre bas succeeded in improving survival with low cost technology without compromising the quality. Neurodevelopmental handicap was low on a 1-year follow-up. No baby had retinopatfay of prematurity or bearing deficit. Dropout rate has been high although comprising of mainly full-terra or near-term babies with mild perinatal asphyxia or mild respiratory distress or requiring instrumentation during delivery. Longer follow-up is desirable.
S. B. KADAM ET AL.
TABLE 2
Distribution of risk factors in 'Follow-up' group and 'Lost-to-follow-up' group No. of patients
High risk factor
Lost to follow-up group
68 56 15 25 57 38 5 4 5 44
43 53 8 11 41 25 2 1 3 34
4
3
Neurological examination was carried out as per the classic method of Paine and Oppe. Psychological assessment was done by a clinical psychologist without prior knowledge of the neonatal history using Bayley Scale of Infant Development 2 (BSID) between 9 and 12 months of age. Average Motor Development Index (MDI) and Psychomotor Developmental Index (PDI) were calculated for every baby. Gross hearing was tested clinically. Startle response, blinking of eyes, sudden changes in the activity with greater alertness were expected in response to sound. In a suspected case of hearing loss, brain stem auditory evoked response study was planned. Gross vision was tested in all patients. Babies with birth weight less than 1500 g or gestational age less than 32 weeks were subjected to fundoscopy to detect retinopathy of prematurity. (ROP). Neurodevelopment handicap (NDH) was defined as major neurological defect or an average MDI and PDI score < 80.2 Statistical analysis Results were analysed by binary regression method with NDH as a dependent variable (y) and 14 different risk factors as independent variables (
*
,
-
,
*
)
Variables and factors
Factor value
1. Socio-economic status Low socio-economic group Average socio-economic group
16.00 18.52
2. Significant antenatal history Present Absent
12.22 18.61
3. Gestational age Less than 37 weeks More than 37 weeks
22.06 10.17
4. Birth weight VLBW LBW Average
26.67 14.06 16.67
0.04
0.34
1.33
0.58
5. Relationship of gestational age to BW SGA AGA & LGA
6.67 19.59
6. Fetal distress Present Absent
29.82 5.71
7. Birth asphyxia-Apgar score at 1 min. Less than or equal to 5 6-10
Weighting factor
1.14
5.45
7.00 44.00 9.80
8. Birth asphyxia-Apgar score at 5 min. Less than or equal to 5 6-10
29.96 125.00 9.24
9. Neonatal seizures Present Absent
120.00 12.30
10. Assisted deliveries Present Absent
31.58 10.12
11. Respiratory distress Present Absent
31.81 8.43
12. Sepsis Present Absent
80.00 13.93
16.62
3.66
4.69
•
A factor value was calculated from the equation by regression coefficient to the constant term and then multiplying this by 100. The factor value represents probability of NDH for that risk factor. Each variable may explain different proportion of total variance, therefore weighting factor for each variable was calculated. It was equal to the percentage that the R2 of that variable represented in respect to the sum of the R2 values of all the variables (Tables 3 and 4). Total risk score was then calculated by multiJournal of Tropical Pediatrics
Vol. 37
October 1991
13. Hyperbilirubinaemia Present Absent 14. Apnoea more than 20 sec. Present Absent
6.25
21.94 150.00 12.12 8.83 25.00 16.26
251
Downloaded from http://tropej.oxfordjournals.org/ at University of Arizona on September 5, 2015
1. Prematurity 2. Birth weight—LBW —VLBW 3. Birth asphyxia 4. Fetal distress 5. Assisted deliveries 6. Neonatal seizures 7. Hyperbilirubinaemia 8. Sepsis 9. Respiratory distress 10. Apnoea more than 20 sec.
Follow-up group
TABLE 3
Factor values and weighting factors for the independent variables
S. B. KADAM ET AL.
TABLE 4
Risk prediction with different variables Predicted risk Test of significance
High
1. Socio-economic status Low Average
55 16
45 11
NS
2. Significant antenatal history Present Absent
22 49
19 37
NS
3. Gestational age equal and Less than 37 weeks More than 37 weeks
44 27
24 32
*
4. Birth weight Less than 1500 g 1500-2490 g 2500-and more
8 26 37
7 30 19
NS
5. Relation of birth weight to gestational age SGA SGA
16 55
14 42
NS
6. Foetal distress Present Absent
15 56
42 14
Weighting factor
Variables 1. 2. 3. 4. 5. 6. 7. 8. 9.
Birth asphyxia Apgar score at 5 min < 5 Hyperbilirubinaemia Neonatal seizures Birth asphyxia Apgar score at 1 min. < 5 Sepsis Fetal distress Respiratory distress Assisted deliveries Gestational age
29.96 21.94 16.62 7.00 6.25 5.45 4.69 3.66 1.33
TABLE 6
Risk prediction in followed-up group
7. Apgar Score (1 min.) 5 and less More than 5
0 71
25 31
*••
8. Apgar Score (5 min.) 5 and less More than 5
0 71
8 48
+4
9. Seizures Present Absent
0 71
5 51
*
10. Assisted deliveries Present Absent
7 64
31 25
11. Respiratory distress Present Absent
17 54
27 29
*
12. Sepsis Present Absent
0 71
5 51
•
13. Hyperbilirubinaemia Present Absent
0 71
4 52
*
14. Apnoea (20 sec. and more) Present Absent
2 69
2 54
NS
252
TABLE 5
Statistically significant variables in order of predicting weightage for NDH
Risk prediction Low High
Total score
Patients (no.)
13.39 and less 13.40 and more
71 56
Risk of NDH was predicted with each independent variable and tests of significance (either Chisquare or Z test) were applied to see whether risk prediction varies with presence or absence of 14 variables (Table 7). Independent variables having good weighting factor with statistically significant variance were considered predictors of risk for NDH. TABLE 7
Predicted and measured degree of neurodevelopmental handicap Actual neurodevelopmental outcome Predicted
risk
Minor NDH
Major NDH
Nil
Total
Low High
1 4
1 7
69 45
71 56
Total
5
8
114
127
Journal of Tropical Pediatrics
Vol. 37
October 1991
Downloaded from http://tropej.oxfordjournals.org/ at University of Arizona on September 5, 2015
Low
Risk factor
plying the weighting factors by the respective factor value for each variable and then adding these scores for all the 14 variables (Table 5). All the infants were grouped into high and low risk prediction by means of median of total risk score. Those infants who had total risk score more than 13.40 were considered as having high risk of prediction of NDH and those with score less than 13.39 were grouped into low risk of prediction of NDH (Table 6).
S B KADAM ET AL.
Journal of Tropical Pediatrics
Vol. 37
October 1991
care 7 is comparable with modern 'aggressive' care. However, it would have been desirable to have a longer follow-up. Reference 1. Paine RS. Neurological examination of infant and children. Pediat Clin N Am 1960; 7: 471-509. 2. Bayley N. Bayley Scales of infant development. New York: The Psychological Corporation, 1969.' 3. DeSouza SW, Richards B. Neurological sequelae in newborn babies after perinatal asphyxia. Arch Dis Childh 1978; 53: 564-9. 4. Saigal S. The outcome of VLBW—Past, present and future. Ind J Pediat. 1986; 53: 365-71. 5. Hilda K, RideT R. Neuropsychiatric sequelae of prematurity. J Am Med Ass; 161: 581-8. 6. Hilary S. Outcome of severe asphyxia. Arch Dis Childh 1976; 51: 712-16. 7. Daga SR, Daga AS. Mortality prevention potential of conservative neonatal care. J Trop Pediat 1986; 32: 183-7. Appendix 1
List of independent variables studied 1. Socio-economic status. 2. Significant antenatal history. 3. Gestational age. 4. Birth weight. 5. Relationship of GA to birth wt. 6. Birth asphyxia Apgar score at 1 min. 7. Birth asphyxia Apgar score at 5 min. 8. Fetal distress. 9. Assisted deliveries. 10. Respiratory distress. 11. Neonatal seizures. 12. Hyperbilirubinaemia. 13. Sepsis. 14. Apnoea more than 20 sec.
253
Downloaded from http://tropej.oxfordjournals.org/ at University of Arizona on September 5, 2015
Results and Discussion Many authors have studied the quality of survival. Unfortunately, most of these studies are unidirectional, involving one aspect of the quality of survival3 or just one risk factor.4"* Studying the impact of many high-risk factors on different aspects of neurodevelopmental outcome is necessary. Since, often more than one risk factors are present in a baby (Tables 3 and 4). The drop-out rate has been high in our study. Two factors are thought to be responsible. The hospital caters for the low income groups, the majority of whom are slum or pavement dwellers who frequently move and, hence, are difficult to trace on home-visits. Secondly, term and near-term babies with intraparum asphyxia or less severe neonatal problems such as transient tachypnoea of newborn formed a large proportion of these babies, admitted often for 'observation'. Follow-up was considered unnecessary by the parents since these babies were 'normal'. Asphyxia with and Apgar Score of less than 5 at 1 and 5 minutes, hyperbilirubinaemia, convulsions, sepsis, fetal distress, respiratory distress, assisted delivery and low gestational age have been found to be predictors of high risk for neurodevelopmental handicap. Out of 127 infants followed up, five (4 per cent) had minor NDH and eight (6 per cent) had major NDH. No baby developed ROP. It is difficult to compare this study with other studies since they have largely confined themselves to the influence of limited factors on the outcome. Besides, the ethnicity, socio-economic status, antenatal care, type of obstetric care and neonatal care have been radically different to make any reasonable comparison possible. Still it can be safely said that the outcome in respect to two commonest parameters studied, viz LBW/prematurity and asphyxia on 'conservative'
