Neonatal respiratory failure remains a significant challenge in neonatal intensive care units (NICUs), imposing the use of mechanical ventilation (MV) to sustain life and support pulmonary function [1,2]. While MV has been instrumental in reducing neonatal mortality, it is associated with various complications that can impact short- and long-term outcomes. Understanding these outcomes and complications is essential for improving neonatal care practices and patient prognostication [3]. Recent studies have highlighted the prevalence of MV-related complications, such as ventilator-associated pneumonia (VAP), atelectasis, and pneumothorax, which contribute to prolonged NICU stays and increased mortality rates. A study by Nasir et al. (2024) reported a 49.4% mortality rate among neonates requiring MV, with pneumonia and pulmonary hemorrhage being the most common complications [4]. Similarly, a study identified factors influencing extubation failure, emphasizing the need for early identification of at-risk neonates to prevent adverse outcomes [5]. In India, where neonatal care practices vary across regions, understanding the local epidemiology of MV-related complications is essential. A study by Kumar J. et al.[6] (2025) provided an evidence-based approach to invasive MV in neonates, discussing indications, strategies, and outcomes This underscores the importance of region-specific data to inform clinical practices and resource allocation in NICUs. This study aims to evaluate the outcomes and complications associated with mechanical ventilation in neonates admitted to a tertiary care hospital. By analyzing clinical data, we seek to identify prevalent complications, assess their impact on neonatal outcomes, and provide recommendations to enhance care strategies in similar healthcare settings.

This cross-sectional study was conducted at the Neonatal Intensive Care Unit (NICU) of a government tertiary care research and teaching institute in North India between January 2020 and December 2021. A total of 150 consecutive neonates aged 0–28 days, who required invasive mechanical ventilation for more than 12 hours, were screened. After applying these criteria, 150 neonates were included in the study. Ethical approval was obtained from the Institute’s Ethical Committee, and written informed consent was taken from parents or guardians. A detailed history and clinical examination were recorded using a structured proforma, and relevant investigations were performed. Mechanical ventilation was initiated for indications such as PaO₂ <60 mmHg, persistent or recurrent apnea, gasping or inadequate respiration, or oxygen saturation <60% despite CPAP pressure of 7–8 cm H₂O with FiO₂ 0.8. All neonates were initially placed on synchronized intermittent mandatory ventilation (SIMV) mode, with pressure support ventilation used during weaning. Typical initial settings included a tidal volume of 4–6 ml/kg, PEEP 4–8 mmHg, PIP 18–28 mmHg, inspiratory time of 0.25–0.5 seconds, and FiO₂ 0.40–0.80. Vital signs were monitored every two hours, and daily arterial blood gas analysis along with other relevant tests was conducted until extubation. Supportive management followed NICU protocols, including intravenous fluids adjusted for weight and age, empirical antibiotics modified according to culture results, and expressed breast milk feeds once the neonate was hemodynamically stable. Ventilator settings were individualized based on clinical condition and acid–base balance, and weaning was attempted once clinical improvement was evident. Outcomes were categorized as survivors, defined as successful extubation without re-intubation, and non-survivors, defined as those who died after 12 hours of ventilation or within 48 hours of extubation. Complications such as sepsis, shock, disseminated intravascular coagulation (DIC), air leak syndrome, ventilator-associated pneumonia, pulmonary hemorrhage, and intraventricular hemorrhage were documented and managed as per NICU protocols. Data analysis was performed using SPSS version 23. Categorical variables were expressed as numbers and percentages, while continuous variables were presented as mean ± standard deviation. Associations were assessed using the Chi-square test, with a p-value <0.05 considered statistically significant. Variables significant on univariate analysis were further subjected to multivariate logistic regression to identify independent predictors of mortality.

Table 1. Demographic Characteristics of Study Population. Variable Category N % Age distribution < 3 days 108 72.0 3–7 days 23 15.3 > 7 days 19 12.7 Sex Male 95 63.3 Female 55 36.6 Birth weight <1000 g 2 1.3 1000–1500 g 27 18.0 1500–2500 g 58 38.7 >2500 g 63 42.0 Gestational age <28 weeks 2 1.3 28–32 weeks 27 18.0 33–36 weeks 32 21.3 >36 weeks 89 59.3 The study included 150 neonates who required mechanical ventilation. The majority (72.0%) were <3 days of age, followed by 15.3% between 3–7 days and 12.7% older than 7 days. Males constituted 63.3% of the population, while females accounted for 36.6%. With respect to birth weight, 42.0% weighed >2500 g, 38.7% between 1500–2500 g, 18.0% between 1000–1500 g, and only 1.3% had extremely low birth weight (<1000 g). Gestational age distribution showed that 59.3% were term (>36 weeks), 21.3% were late preterm (33–36 weeks), 18.0% were moderately preterm (28–32 weeks), while 1.3% were extremely preterm (<28 weeks). This demographic profile indicates that most ventilated neonates were term or near-term, with a significant proportion being low birth weight. Table-2: Modes and Factors Affecting Outcome of Mechanical Ventilation Factor Category Discharge n (%) Died n (%) Total n (%) p-value Modes of Ventilation SIMV 96 (84.2) 18 (15.7) 114 (76.0) 0.005 AC 17 (58.6) 12 (41.3) 29 (19.3) PSV 4 (57.1) 3 (42.8) 7 (4.7) Age Interval < 3 days 82 (75.9) 26 (24.0) 108 (72.0) 0.421 3–7 days 18 (78.2) 5 (21.7) 23 (15.3) > 7 days 17 (89.4) 2 (10.6) 19 (12.7) Sex Male 74 (77.8) 21 (22.2) 95 (63.3) 0.967 Female 43 (78.1) 12 (21.1) 55 (36.7) APGAR at 1 min >5 16 (64.0) 9 (36.0) 25 (16.7) 0.042 <5 31 (91.1) 3 (8.8) 34 (22.7) NA 70 (76.9) 21 (23.1) 91 (60.7) APGAR at 5 min >5 25 (73.5) 9 (26.5) 34 (22.7) 0.384 <5 22 (88.0) 3 (12.0) 25 (16.7) NA 70 (76.9) 21 (23.1) 91 (60.7) Foul smelling liquor / MSL Present 35 (74.0) 12 (25.5) 47 (31.3) 0.481 Absent 82 (79.6) 21 (20.3) 103 (68.7) ROM > 24 hrs Present 40 (71.4) 16 (28.5) 56 (37.3) 0.134 Absent 77 (81.9) 17 (18.1) 94 (62.7) Prolong labour Present 15 (83.3) 3 (16.6) 18 (12.0) 0.560 Absent 102 (77.2) 30 (22.7) 132 (88.0) Vaginal examinations (unclean or >3 clean) Present 13 (61.9) 8 (38.1) 21 (14.0) 0.055 Absent 104 (80.6) 25 (19.3) 129 (86.0) The outcome varied significantly across different ventilation modes (p=0.005). The highest survival was observed in neonates managed with synchronized intermittent mandatory ventilation (SIMV), with 84.2% being discharged, whereas mortality was higher in those ventilated with assist-control (41.3%) and pressure support ventilation (42.8%). Age distribution did not significantly affect outcome (p=0.421); neonates older than 7 days demonstrated the best survival (89.4%). Sex was not a predictor of outcome (p=0.967), with comparable survival in males (77.8%) and females (78.1%). APGAR score at 1 minute was significantly associated with survival (p=0.042), with lower APGAR (<5) showing better survival (91.1%) compared to higher scores, suggesting reverse influence due to clinical context. However, APGAR at 5 minutes was not statistically significant (p=0.384). Antenatal risk factors, including foul-smelling liquor (p=0.481), rupture of membranes >24 hours (p=0.134), prolonged labor (p=0.560), and multiple vaginal examinations (p=0.055), showed no statistically significant effect on survival. Table 3: Clinical Signs Affecting the Outcome of Mechanical Ventilation Clinical Sign Outcome – Discharge (N, %) Outcome – Died (N, %) Total (N, %) p-value Anemia 19 (76.0%) 6 (24.0%) 25 (16.7%) 0.791 Absent Anemia 98 (78.4%) 27 (21.6%) 125 (83.3%) Cyanosis 34 (66.6%) 17 (33.3%) 51 (34.0%) 0.016* Absent Cyanosis 83 (83.8%) 16 (16.1%) 99 (66.0%) Edema 19 (73.1%) 7 (26.9%) 26 (17.3%) 0.505 Absent Edema 98 (79.0%) 26 (20.9%) 124 (82.7%) Jaundice 21 (84.0%) 4 (16.0%) 25 (16.7%) 0.428 Absent Jaundice 96 (76.8%) 29 (23.2%) 125 (83.3%) Respiratory Failure (Distress) 75 (78.0%) 20 (21.0%) 95 (63.3%) 0.579 Apnea 29 (72.5%) 11 (27.5%) 40 (26.7%) GCS (Coma) 12 (85.7%) 2 (14.3%) 14 (9.3%) Among the clinical signs, the presence of cyanosis was significantly associated with poor outcome (p=0.016), with a mortality rate of 33.3% compared to 16.1% in those without cyanosis. Other parameters such as anemia (p=0.791), edema (p=0.505), and jaundice (p=0.428) did not show significant correlation with survival. Respiratory failure and apnea were common clinical features, accounting for 63.3% and 26.7% of cases respectively, but did not significantly alter outcome (p=0.579). Notably, neonates with coma (GCS depression) had the highest survival (85.7%), although this was not statistically significant due to small numbers. Table 4: Clinical Outcomes by Diagnosis, Sepsis, and Extubation Status. Variable / Category Outcome – Discharge (N, %) Outcome – Died (N, %) Total (N, %) p-value Diagnosis   BAHIE 61 (81.3%) 14 (18.7%) 75 (50.0%) 0.034*   MAS 5 (83.3%) 1 (16.7%) 6 (4.0%)   Meningitis / Sepsis 25 (92.6%) 2 (7.4%) 27 (16.0%)   RDS 26 (62.0%) 16 (38.0%) 42 (28.0%) Sepsis Screen <0.001**   Positive 46 (63.0%) 27 (36.9%) 73 (48.7%)   Negative 71 (92.2%) 6 (7.8%) 77 (51.3%) Extubation Status <0.001**   Weaned 94 (100.0%) 0 (0.0%) 94 (62.7%)   Self-extubated 23 (100.0%) 0 (0.0%) 23 (15.3%)   Not extubated 0 (0.0%) 33 (100.0%) 33 (22.0%) The distribution of outcomes by diagnosis showed statistical significance (p=0.034). The highest survival was observed in neonates with meningitis/sepsis (92.6%), followed by MAS (83.3%) and birth asphyxia/hypoxic-ischemic encephalopathy (81.3%), whereas those with respiratory distress syndrome had the lowest survival (62.0%). Sepsis screen status was strongly associated with outcome (p<0.001), with mortality being 36.9% among sepsis-positive neonates compared to only 7.8% in sepsis-negative cases. Extubation status was also a powerful predictor of outcome (p<0.001). All neonates who were successfully weaned or self-extubated survived, while 100% mortality was observed in those who could not be extubated, highlighting the prognostic value of extubation status. Table 5: Mechanical Ventilation Complications Affecting Outcome Complication Outcome – Discharge (N, %) Outcome – Died (N, %) Total (N, %) p-value Any Complication Present 91 (78.4%) 25 (21.6%) 116 (77.3%) 0.807 Air Leak   Absent 26 (76.5%) 8 (23.5%) 34 (22.7%) 0.677   Present 9 (69.2%) 4 (30.8%) 13 (8.7%) Tube Block   Absent 106 (77.4%) 31 (22.6%) 137 (91.3%) <0.001**   Present 5 (55.6%) 4 (44.4%) 9 (6.0%) Pneumothorax   Absent 112 (79.4%) 29 (20.6%) 141 (94.0%) <0.001**   Present 3 (42.9%) 4 (57.1%) 7 (4.7%) Pulmonary Hemorrhage   Absent 114 (79.7%) 29 (20.3%) 143 (95.3%) <0.001**   Present 51 (66.2%) 26 (33.8%) 77 (51.3%) Shock   Absent 66 (78.6%) 18 (21.4%) 84 (56.0%) 0.063   Present 12 (92.3%) 1 (7.7%) 13 (8.7%) Subcutaneous Emphysema   Absent 105 (76.6%) 32 (23.4%) 137 (91.3%) Ventilator-Associated Pneumonia (VAP)   Present 7 (58.3%) 5 (41.7%) 12 (8.0%) 0.086   Absent 110 (79.7%) 28 (20.3%) 138 (92.0%) Mechanical ventilation complications significantly influenced outcome in selected categories. Tube block (p<0.001), pneumothorax (p<0.001), and pulmonary hemorrhage (p<0.001) were strongly associated with increased mortality. For instance, mortality in neonates with tube block was 44.4% compared to 22.6% without, while pneumothorax was associated with a mortality of 57.1%. Pulmonary hemorrhage also showed poor prognosis, with 33.8% mortality compared to 20.3% in those without. Other complications such as air leak (p=0.677), shock (p=0.063), subcutaneous emphysema, and ventilator-associated pneumonia (p=0.086) did not reach statistical significance. However, trends suggested higher mortality in neonates with these complications.

Preterm neonates requiring invasive mechanical ventilation after initial lower-level respiratory support are at higher risk of pneumothorax, prolonged ventilatory dependence, Broncho pulmonary dysplasia, and mortality compared to those managed with CPAP or less intensive support. Early identification of these high-risk neonates is essential to implement targeted interventions aimed at minimizing complications and improving outcomes. In the present study, among 150 mechanically ventilated neonates, the majority were less than three days old (72.0%), male (63.3%), and term (59.3%), with a significant proportion being low birth weight (<2500 g). Survival was highest with synchronized intermittent mandatory ventilation (SIMV, 84.2%), while assist-control and pressure support modes were associated with higher mortality. Clinical factors such as cyanosis, positive sepsis screen, inability to extubate, and ventilation-related complications including tube block, pneumothorax, and pulmonary haemorrhage were significantly associated with poor outcomes. Diagnosis-specific survival was highest in meningitis/sepsis (92.6%) and meconium aspiration syndrome (83.3%), whereas respiratory distress syndrome carried the highest mortality (38%). These findings highlight that both underlying patient characteristics and ventilatory management strategies critically influence outcomes. These observations are consistent with Iqbal et al. [8] (2015), who reported that low birth weight (<2500 g), gestation <34 weeks, initial arterial pH <7.1, sepsis, shock, pulmonary hemorrhage, and hematological abnormalities were significant predictors of mortality in ventilated neonates. Kumar D et al.[2] (2024) similarly identified gestational age <34 weeks, low initial blood pH, prolonged ventilation, and sepsis or shock as independent predictors of mortality, with hospital-acquired sepsis being a major complication. The present study expands on these findings by additionally highlighting the prognostic importance of ventilation mode (SIMV) and successful extubation as strong predictors of survival. Kim Y et al. [9] (2023) reported that lower gestational age and birth weight were associated with increased need for invasive mechanical ventilation and prolonged hospitalization, emphasizing the vulnerability of preterm and low-birth-weight neonates, which is in line with the current study’s observation that term and near-term neonates had comparatively better outcomes. Gupta et al.[10] (2023) also found that prematurity, neonatal sepsis, and birth asphyxia were the major contributors to mechanical ventilation, with preterm neonates being nearly three times more likely to require ventilation, corroborating the present study’s finding that sepsis and cyanosis were significant predictors of poor outcome. Furthermore, Gates et al.[11] (2025) demonstrated that early prediction of invasive mechanical ventilation requirement is possible using clinical parameters such as FiO₂, birth weight, gestational age, oxygenation, and blood pressure, achieving high predictive accuracy. The present study highlights this concept by showing that careful assessment of clinical status, ventilator settings, and early recognition of complications can influence survival. Collectively, these studies highlight that neonatal outcomes depend on a combination of intrinsic patient factors (gestation, birth weight, sepsis), diagnosis, clinical presentation, and ventilatory management strategies. Early identification of high-risk neonates, timely initiation of appropriate ventilation, meticulous monitoring, and prevention of complications remain essential for improving survival in ventilated neonates.

In this study of 150 mechanically ventilated neonates, most were male, term, and under three days old. Survival was highest with SIMV ventilation, while assist-control and pressure support modes were associated with higher mortality. Cyanosis, positive sepsis screen, failure to extubate, and ventilation-related complications such as tube block, pneumothorax, and pulmonary haemorrhage emerged as significant predictors of poor outcomes. Age, sex, anemia, edema, jaundice, and respiratory distress did not significantly influence survival. Recognizing these predictors early and applying appropriate ventilation strategies can help clinicians identify high-risk neonates and improve overall outcomes, especially in resource-limited NICU settings.

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