Epidemiology and Risk Factors Predicting Mortality in Neonates with Meconium Aspiration Syndrome: A Multicentre Retrospective Study.

doi:10.21203/rs.3.rs-4711365/v1

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Epidemiology and Risk Factors Predicting Mortality in Neonates with Meconium Aspiration Syndrome: A Multicentre Retrospective Study.

https://doi.org/10.21203/rs.3.rs-4711365/v1

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Background

Meconium aspiration syndrome (MAS) is a significant cause of mortality and morbidity in term and post-term neonates born through meconium-stained amniotic fluid (MSAF). Numerous antenatal and intrapartum risk factors are associated with mortality, and it is crucial for obstetricians to avoid these risk factors and for neonatologists to institute adequate therapy to improve outcomes.

Aim

To determine the predictors of mortality in neonates with meconium aspiration syndrome

Methods

This retrospective study reviewed data from four regional hospitals over three years from 01 January 2015 to 31 December 2017. During the study period, data were recorded with regard to sex, mode of delivery, gestational age, maternal age, asphyxia, Apgar score at one and five minutes, persistent pulmonary hypertension, and respiratory support of neonates with MAS.

Results

Of the 187 neonates identified with MAS, 30 died, with a case fatality rate of 16%. Ninety-seven (51.9%) neonates were diagnosed with asphyxia, 91 (48.7%) with seizures, and 55 (27.3%) with PPHN. The factors associated with mortality were male sex (p = 0.009), a low Apgar (< 7 at five minutes) (p = 0.003), asphyxia (p ≤ 0.001), any form of resuscitation (p = 0.003 and < 0.001), bag-mask ventilation (BMV) and cardiac massage, respectively, and the presence of PPHN (p = 0.007) and air leakage (p = 0.002). After adjusting for all variables, the presence of asphyxia and air leakage were significantly associated with mortality, with ORs of 39.79 (3.93–1151) and 79.46 (3.53–2985), respectively.

Conclusion

Meconium aspiration syndrome is a significant cause of mortality. Asphyxia and air leakage are significant contributors to mortality in neonates with MAS. Continuous fetal monitoring, early recognition of fetal distress, and timely intervention during the intrapartum period are crucial for preventing asphyxia. Postnatally, neonates with MAS should be managed appropriately to prevent PPHN and air leakage, and seizures should be well controlled.

Meconium aspiration syndrome

air leak

asphyxia

PPHN

postterm neonate

pneumothorax

foetal distress

hypoxic ischaemic encephalopathy and seizures

Meconium aspiration syndrome (MAS) is associated with significant mortality and morbidity that varies between developed and developing countries based on the available resources. There are numerous retrospective studies identifying factors that predict mortality. Mortality rates are greater in developing countries than in developed countries, ranging from 10–26% in developing countries [1, 2, 3]. In the United States of America (USA), studies performed during the periods 1973 to 1987, 1990 to 1998 and 1998 to 2000 showed mortality rates of 28 per 100 000, 4.6 per 100 000 and 2 per 100 000 live births, respectively. [4] These population-based estimates of mortality from MAS between 1998 and 2000 are markedly lower than those of hospital birth cohorts [5]. In a study by Sriram et al., the case fatality rate of meconium aspiration syndrome was similar between non-Hispanic blacks and non-Hispanic whites over three periods (1989–1991, 1995–1997, and 1998–2000), with rates of 15.5, 15.2, and 11.2 per 1 000 in non-Hispanic blacks and 13.5, 11.2, and 10.1 per 1 000 in non-Hispanic whites, respectively[5]. In an Australian and New Zealand neonatal network study from 1995–2002, neonates with a primary diagnosis of MAS exhibited a mortality rate of 2.5%, with the uptake of exogenous surfactant, high-frequency ventilation, and inhaled nitric oxide increasing during the study period [6]. The decrease in mortality in this study was attributed to better obstetric practices, in particular, avoidance of postmaturity, expeditious delivery where foetal distress had been noted and avoidance of routine suctioning of the trachea. [6] In Saudi Arabia, between 1989 and 1994, the mortality rate for MAS was 7%[7].

Asphyxia, pneumothorax and PPHN are the most important risk factors for mortality [8]. The predictors of mortality included small for gestational age, a five-minute Apgar score < 7, severe hypoxic-ischemic encephalopathy (HIE), the requirement for bag-mask ventilation and chest compression at birth and the need for assisted ventilation[9]. In a case‒controlled study over six years from India, myocardial dysfunction and high initial oxygen requirements were independently associated with increased odds of mortality [3]. Of the 170 neonates diagnosed with MAS during the study period, 44 (26%) died, 37 of whom had myocardial dysfunction presenting as cardiogenic shock in 31 (18%), elevated CPK-MB in five (3%) and tricuspid regurgitation in one (0.6%) [3]. A retrospective study in Taiwan between 1995 and 2005 indicated that the presence of 314 infants with MAS who required resuscitation in the birth room and who experienced perinatal asphyxia and infants who developed persistent pulmonary hypertension (PPHN) and pneumothorax were important factors associated with increased mortality [10]. The clinical data of neonates with MAS who were admitted to a public hospital in South Africa for mechanical ventilation between January 2004 and December 2006 were retrospectively reviewed. Among the 88 patients with MAS, the mortality rate was 33%. The factors associated with mortality were high peak inspiratory pressure (p < 0.001), pneumothorax (p < 0.001) and PPHN (p = 0.001) [11]. In another retrospective study of neonates diagnosed with MAS, which was conducted in the form of a questionnaire in 11 hospitals in South Africa in 1995, the mortality rate was 12%. Babies born to mothers with advanced maternal age, Apgar scores of < 5 at five minutes and prolonged resuscitation after birth contributed to mortality [12].

It is crucial to identify risk factors for mortality so that measures can be taken to avoid these risk factors and interventions can be implemented quickly.

Aim

To determine the outcome and predictors of mortality in neonates with meconium aspiration syndrome.

This was a retrospective descriptive study. Charts of neonates born with a diagnosis of MAS in four regional hospitals between 01 January 2015 and 31 January 2017 were analysed. The hospitals included King Edward VIII Hospital (K1), RK Khan Hospital (R1), Mahatma Gandhi Memorial Hospital (M1) and Prince Mshiyeni Memorial Hospital (P1). The information collected was captured on Microsoft Excel, which was password protected and exported to SPSS version 25. Gatekeeper permission was obtained from the respective hospitals and the Biomedical Research Ethics Committee (BREC) of the University of KwaZulu-Natal (BE022/17).

In this retrospective study, risk factors associated with mortality, including sex, gestational age, birth weight, maternal age, place of delivery, Apgar score at one and five minutes, seizures, asphyxia and respiratory support, were analysed.

The severity of MAS was classified based on the classification by Cleary and Wiswell [13].

(a) Mild MAS is a disease that requires less than 40% oxygen for less than 48 hours.

(b) Moderate MAS is a disease that requires more than 40% oxygen for more than 48 hours with no air leakage.

(c) Severe MAS is a disease that requires assisted ventilation for more than 48 hours and is often associated with persistent pulmonary hypertension (PPHN).

A low Apgar score at 5 min was defined as an Apgar score < 7. Asphyxia was defined as a low APGAR associated with seizures and an altered level of consciousness [14]. Neonates with hypoxic-ischemic encephalopathy(HIE) were classified as mild, moderate or severe based on the Sarnat and Sarnat classification [15].

The diagnosis of persistent pulmonary hypertension (PPHN) was based on clinical data for the majority of patients since there was no resident cardiologist at the regional hospitals. The clinical diagnosis of PPHN was based on a differential saturation > 10 between the preductal and postductal oxygen saturation and a partial pressure of oxygen (Pao2) > 20 mmHg [16].

Statistical analysis

Quantitative data are presented as the mean and standard deviation. Qualitative data are presented as percentages. Logistic regression was used to determine significant independent variables associated with risk factors predicting the severity of MAS. A p value of < 0.05 was considered to be of statistical significance. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. The analysis was performed using SPSS version 25.

Of the 187 neonates diagnosed with MAS over the three years, 56 had mild to moderate MAS, and 131 neonates had severe MAS. Of the 30 (16%) neonates who died, 15 had PPHN, six had HIE grade 3, and six had a gestational age between 41 and 43 weeks. There was no difference in mortality based on the severity of illness between mild-moderate and severe MAS patients (17.9 vs 15.3%; p = 0.65). Of the ten patients who died in the mild to moderate group, four (40%) had HIE grade 3. Since they were managed with nasal prong oxygen, these neonates were classified into the mild to moderate group according to the classification of Cleary and Wiswell.¹³ The mean and median duration of stay of babies who died were 2.1 and 2 days, respectively, compared to survivors whose mean and median duration of stay were 10 and 8 days, respectively.

Risk factors and outcome

The risk factors and outcomes are presented in Table 1a and 1b. The mean gestational age was greater for neonates who died (39.9) than for survivors. According to the Ranksum test, the median gestational age of the patients who died was significantly greater than that of the survivors (p = 0.008). The risk of mortality increased for neonates of greater gestational age, with a confidence interval ranging from 0.49–0.98. The mean and median maternal age were greater in the neonates who died (27.9 and 29.0 years, respectively) than in the survivors (25.0 and 24.0 years, respectively), with a p value of 0.047. One hundred and nineteen (63.6%) of the neonates were male. Mortality in males was significantly greater than that in females (p value = 0.009). HIV exposure and mode of delivery (caesarean section or normal vaginal delivery) did not contribute to mortality, with p values of 0.288 and 1.0, respectively. Thirty-five (18.7%) neonates had an Apgar score < 7 at five minutes, which was associated with a significant increase in mortality (p value = 0.003). Of the 30 neonates who died, 25 (83.3%) had associated asphyxia, while 72 (45.9%) of the survivors died. One hundred and twenty-eight (68.4%) neonates required IPPV, 20 (15.6%) of whom died. Of the 27 neonates who required CPAP, five required it as initial respiratory support, and 22 were supported postextubation.

Table 1

a: Risk factors and outcomes of neonates with MAS
Outcome	Survived (n = 157)	Died (n = 30)	p value	Overall (n = 187)
Birth weight(gm)			0.591
Mean ± SD(CV%)	3160 ± 480(15.2)	3110 ± 503(16.2)		3160 ± 483(15.3)
Median(Q1-Q3)	3200(2900–3490)	3000(2800–3500)		3180(2900–3490)
Min–Max	1960–4410	1870–4020		1870–4410
Missing	0 (0%)	1 (3.3%)		1 (0.5%)
Gestational age(weeks)			0.008
Mean ± SD(CV%)	39.2 ± 1.54(3.9)	39.9 ± 1.27(3.2)		39.3 ± 1.52(3.9)
Median(Q1-Q3)	40.0(38.0–40.0)	40.0(40.0–40.0)		40.0(39.0–40.0)
Min–Max	34.0–43.0	35.0–41.0		34.0–43.0
Missing	0 (0%)	2 (6.7%)		2 (1.1%)
Maternal age			0.047
Mean ± SD(CV%)	25.0 ± 5.95(23.8)	27.9 ± 6.36(22.8)		25.3 ± 6.06(23.9)
Median(Q1-Q3)	24.0(20.0–29.0)	29.0(23.0-31.3)		25.0(20.0–29.0)
Min–Max	15.0–41.0	16.0–39.0		15.0–41.0
Missing	25 (15.9%)	10 (33.3%)		35 (18.7%)
HIV			0.288
Unexposed	89 (56.7%)	14 (46.7%)		103 (55.1%)
Exposed	62 (39.5%)	15 (50.0%)		77 (41.2%)
Missing	6 (3.8%)	1 (3.3%)		7 (3.7%)
Growth			0.878
AGA	141 (89.8%)	26 (86.7%)		167 (89.3%)
LGA	7 (4.5%)	1 (3.3%)		8 (4.3%)
SGA	9 (5.7%)	2 (6.7%)		11 (5.9%)
Missing	0 (0%)	1 (3.3%)		1 (0.5%)
Gender			0.009
Male	94 (59.9%)	25 (83.3%)		119 (63.6%)
Female	60 (38.2%)	4 (13.3%)		64 (34.2%)
Missing	3 (1.9%)	1 (3.3%)		4 (2.1%)
Mode of delivery			1.000
Caeserean	96 (61.1%)	18 (60.0%)		114 (61.0%)
NVD	57 (36.3%)	11 (36.7%)		68 (36.4%)
BBA	2 (1.3%)	0 (0%)		2 (1.1%)
Missing	2 (1.3%)	1 (3.3%)		3 (1.6%)
Abbreviations- AGA/LGA/SGA- Appropriate, Large and Small for gestational age, NVD- Normal vaginal delivery, BBA- Born before arrival

Table 1

b: Risk factors and outcomes of neonates with MAS
Outcome	Survived (n = 157)	Died (n = 30)	p value	Overall (n = 187)
Apgar5 min			0.003
Normal	131 (83.4%)	17 (56.7%)		148 (79.1%)
Low	24 (15.3%)	11 (36.7%)		35 (18.7%)
Missing	2 (1.3%)	2 (6.7%)		4 (2.1%)
Place of Delivery			0.833
Inborn	118 (75.2%)	22 (73.3%)		140 (74.9%)
Outborn	39 (24.8%)	8 (26.7%)		47 (25.1%)
IPPV			0.819
No	49 (31.2%)	10 (33.3%)		59 (31.6%)
Yes	108 (68.8%)	20 (66.7%)		128 (68.4%)
CPAP			0.086
No	129 (82.2%)	29 (96.7%)		158 (84.5%)
Yes	26 (16.6%)	1 (3.3%)		27 (14.4%)
Missing	2 (1.3%)	0 (0%)		2 (1.1%)
Seizures			0.269
No	82 (52.2%)	12 (40.0%)		94 (50.3%)
Yes	74 (47.1%)	17 (56.7%)		91 (48.7%)
Missing	1 (0.6%)	1 (3.3%)		2 (1.1%)
Asphyxia			< 0.001
No	82 (52.2%)	5 (16.7%)		87 (46.5%)
Yes	72 (45.9%)	25 (83.3%)		97 (51.9%)
Missing	3 (1.9%)	0 (0%)		3 (1.6%)
Severity			0.658
No-Moderate	46 (29.3%)	10 (33.3%)		56 (29.9%)
Severe	111 (70.7%)	20 (66.7%)		131 (70.1%)
Abbreviations-IPPV- Intermittent positive airway pressure CPAP- Continuous positive airway pressure Low Apgar- < 7 at 5 minutes.

Resuscitation and outcomes

The steps followed in the resuscitation of the neonate included suction, bag-mask ventilation, intubation, cardiac massage and adrenaline in a stepwise manner, based on the response. Very few neonates required cardiac massage (n = 8). Details of suctioning were not documented in the clinical records. Any form of resuscitation was associated with an increase in mortality, as shown in Table 2.

Table 2

Resuscitation steps and outcomes
Outcome	Survived (n = 157)	Died (n = 30)	p value	Overall (n = 187)
Oxygen			0.037
No	36 (22.9%)	2 (6.7%)		38 (20.3%)
Yes	108 (68.8%)	26 (86.7%)		134 (71.7%)
Missing	13 (8.3%)	2 (6.7%)		15 (8.0%)
Bag mask ventilation			0.003
No	94 (59.9%)	10 (33.3%)		104 (55.6%)
Yes	50 (31.8%)	18 (60.0%)		68 (36.4%)
Missing	13 (8.3%)	2 (6.7%)		15 (8.0%)
Intubation			< 0.001
No	131 (83.4%)	16 (53.3%)		147 (78.6%)
Yes	13 (8.3%)	12 (40.0%)		25 (13.4%)
Missing	13 (8.3%)	2 (6.7%)		15 (8.0%)
Cardiac massage			< 0.001
No	142 (90.4%)	22 (73.3%)		164 (87.7%)
Yes	2 (1.3%)	6 (20.0%)		8 (4.3%)
Missing	13 (8.3%)	2 (6.7%)		15 (8.0%)

Complications and outcomes

Two main complications of MAS were PPHN and air leakage, which occurred in 29.4% and 7.4% of the cohort, respectively. Both of these complications were associated with significant mortality, with p values of 0.002 and 0.007, respectively, as shown in Table 3.

Table 3

Complications associated with MAS and outcomes
Outcome	Survived (n = 157)	Died(n = 30)	p value
Air-leak No Yes	148(94.3%) 7(4.5%)	23(6.7%) 7(23.3%)	0.002
PPHN No Yes	117(74.5%) 40(25.5%)	15(50%) 15(50%)	0.007
Abbreviations - PPHN- persistent pulmonary hypertension

According to the logistic regression analysis (Table 4), the independent risk factors for mortality, after controlling for all the variables, were air leakage and the presence of asphyxia. The odds of a baby dying from an air leak were 79 times greater than those of neonates who did not have an air leak, and in neonates with asphyxia, the odds of a neonate dying were 39 times greater than those of a neonate without asphyxia and with MAS.

Table 4

Univariate and multivariate analysis of risk factors associated with outcome
Explanatory	OR (Univariable)	OR (Multivariable)
Sex Female vs Male	0.25 (0.07–0.69, p = 0.014)	0.35 (0.04–2.24, p = 0.295)
Apgar5 Low vs Normal	3.53 (1.45–8.44, p = 0.005)	2.60 (0.40-18.09, p = 0.310)
Oxygen Yes vs No	4.33 (1.21–27.73, p = 0.053)	4.71 (0.29-148.43, p = 0.310)
BMV Yes vs No	3.38 (1.48–8.15, p = 0.005)	1.54 (0.16–16.21, p = 0.703)
Intubation Yes vs No	7.56 (2.95–19.65, p < 0.001)	1.85 (0.16–31.97, p = 0.637)
Cardiac massage Yes vs No	19.36 (4.17-138.04, p < 0.001)	1.51 (0.03–70.66, p = 0.827)
Air-leak Yes vs No	6.43 (2.03–20.50, p = 0.001)	79.46 (3.53-2985.26, p = 0.009)
NPO2 Yes vs No	0.03 (0.01–0.08, p < 0.001)	0.02 (0.00-0.10, p < 0.001)
PPNH Yes vs No	2.92 (1.31–6.56, p = 0.009)	0.76 (0.03–11.81, p = 0.849)
Asphyxia Yes vs No	5.69 (2.23–17.56, p = 0.001)	39.79 (3.93-1151.22, p = 0.009)
Abbreviations: PPHN, persistent pulmonary hypertension; BMV, bag mask ventilation; Apgar5, at 5 minutes; NPO2, nasal prong oxygen

Risk factors contributing to mortality were analysed in this study. The case fatality rate was 16%, and the main risk factors for mortality were the presence of air leakage, asphyxia, PPHN and any form of resuscitation. In neonates who were mechanically ventilated for MAS, the mortality rate was 15.6%. The mortality rate due to MAS in this study was lower than that in the study by Velaphi et al. [11], where the mortality rate due to MAS requiring mechanical ventilation was 33%. In a retrospective study performed by Adhikari et al., the reported mortality rate was 12%, and in neonates who required intensive care, the mortality rate was 36% [12]. A similar mortality rate was observed in other developing countries [1–3]. This decline in mortality in our study could be related to improved antenatal and intrapartum monitoring and early ventilator support.

Risk factors associated with an increase in mortality in this study included male sex and greater gestational age, with p values of < 0.009 and 0.008, respectively. Other risk factors included babies born to mothers of advanced maternal age (p value of 0.047), a low APGAR < 7 at 5 minutes, the presence of asphyxia and air leakage. The presence of air leaks and PPHN had significant effects on mortality, with p values of 0.002 and 0.007, respectively. Air leakage and asphyxia were found to be independent risk factors for mortality.

Among the demographic variables in this study, a greater number of male than female participants resulted in significantly greater male mortality. This is in contrast to the studies by Deepak L et al. and Velaphi et al., where mortality was reported to be greater in females, with p values of 0.046 and 0.02, respectively[3, 11]. Gender was not found to be a significant factor for mortality by Dargaville et al. in their epidemiological study [6].

Advanced gestational age and advanced maternal age were noted to be risk factors for increased mortality in the univariate analysis. Advanced gestational age as a risk factor for mortality has been described in other studies [9, 11]. In a meta-analysis by Hussain et al. of 14 randomized controlled studies, the induction of labour at or beyond 41 weeks significantly decreased neonatal morbidity from MAS (RR = 0.43, 95% CI 0.23–0.79)[17].

A majority (70%) of neonates in this study required some form of resuscitation. Any form of resuscitation was associated with a poorer outcome, with a p value < 0.05. In a study by Deepak Louise et al., a higher initial oxygen requirement increased the odds of dying [3]. This was found to be an independent risk factor. In another study performed in Taiwan, infants who required resuscitation during birth were associated with an increased risk of mortality [8]. In a study by Eva Gauchan et al., neonates who required bag-mask ventilation and chest compressions at birth were associated with increased mortality [9]. In our study, of the eight patients who required cardiac massage, six died. These neonates likely had severe asphyxia.

In our study, a low APGAR at five minutes was associated with an increased risk of mortality. This finding is in keeping with other studies in which a low APGAR at one and five minutes was associated with an increase in mortality [1–3, 6, 9, 18–20]. In our study, 25 (83%) of the 30 neonates who died had associated asphyxia.

Air leakage was significantly associated with mortality in our study. Similar findings were reported in other studies, where the reported incidence of pneumothorax was 9–24% [6, 21, 22]. The presence of pneumothorax is associated with poor outcomes [11, 23].

PPHN was significantly associated with mortality. Similar findings were observed in other studies [3, 11].

In a study by Hung Chi et al., in which 314 cases were reviewed, logistic regression revealed that asphyxia, pneumothorax and PPHN were the most important risk factors for mortality [24]. Similar findings were found in our study. Reducing these factors is key to decreasing mortality. PPHN and air leakage are significant complications of severe MAS and are associated with poor outcomes. Strategies to avoid and treat these complications are necessary to improve morbidity and mortality. In this study, the mortality rate did not significantly differ between patients with mild-moderate MAS and those with severe MAS.

Meconium aspiration syndrome is a significant cause of mortality. The presence of asphyxia, air leakage and PPHN are significant contributors to mortality. Adequate fetal monitoring during the antenatal and intrapartum periods is crucial for identifying fetal distress and preventing asphyxia. Advanced gestational age was a significant contributor to mortality according to univariate analysis. Pregnancy beyond 41 weeks should be avoided. Neonates born with risk factors should be aggressively managed with a special focus on supportive therapy and respiratory care. Gentle ventilation should be advocated to avoid air leaks and prevent hypoxemia.

Asphyxia is associated with an increase in mortality.

Air leakage and persistent pulmonary hypertension (PPHN) are significant complications of meconium aspiration syndrome (MAS) and are associated with mortality.

What this study adds

All forms of resuscitation are associated with mortality, including supplemental oxygen, intubation, bag-mask ventilation and chest compressions. Previous studies have reported bag-mask ventilation and chest compressions as risk factors.

HIV exposure is not a risk factor for mortality in neonates with meconium aspiration syndrome (MAS).

There was no difference in mortality between the mild-moderate group and the severe group. This could be related to the presence of asphyxiated babies in the mild–moderate group.

Ethical considerations

Ethical approval for the study was received from the Biomedical Research Ethics Committee of the University of KwaZulu-Natal (BE022/17), and gatekeeper permission was obtained from all the regional hospitals and the Department of Health.

Limitations of the study

This was a retrospective study, and information regarding maternal factors such as pregnancy complications and the intrapartum period was not obtained. The diagnosis of MAS was based on the documentation of radiological findings in the neonatal charts. Neonates who did not have chest X-rays may have been missed.

Acknowledgements

Our thanks to the staff from the medical records departments at the respective regional hospitals for assisting with obtaining the files and to Mrs. Leora Sewnarain for editing and formatting the article.

Conflict of interest

The authors declare no financial or personal relationship(s), which may have inappropriately influenced them in writing this article.

Source of Support

The authors received no financial support for the research, authorship, or publication of this article.

Disclaimer

The views expressed in the submitted article are the authors’ own and not the official position of the institution.

Availability of data and materials

The datasets used and analysed during the current study are available from the corresponding author upon reasonable request.

Contribution

The principal author (RS) made a substantial contribution to the study conception and design, acquisition of the data, analysis, and interpretation. The coauthors (MA and PMJ) assisted with the discussion and literature review. A biostatistician (PT) assisted with the data analysis and interpretation. All authors critically revised the article for valuable intellectual content and approved the final version to be published.

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Epidemiology and Risk Factors Predicting Mortality in Neonates with Meconium Aspiration Syndrome: A Multicentre Retrospective Study.

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Background

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