Comparison of non-invasive neurally adjusted ventilatory assist and non-invasive ventilation modalities for preterm infants with respiratory distress syndrome: a systematic review and meta-analysis of randomized controlled trials

Introduction

Infants born extremely preterm often require prolonged respiratory support including mechanical ventilation (MV) due to immature pulmonary development. To mitigate the risk of bronchopulmonary dysplasia (BPD) related to MV (1), contemporary efforts have focused on non-invasive respiratory support (NRS) as primary ventilatory support in infants born prematurely with respiratory distress syndrome (RDS) (2-5). Among the different modes of NRS, nasal intermittent positive pressure ventilation (NIPPV) has been superior to nasal continuous positive airway pressure (nCPAP) in reducing the risk of respiratory failure and the need for MV for infants born at 28–32 weeks of gestation (6,7). Although the risk of BPD was less with NIPPV versus CPAP for primary support, neither BPD nor death were decreased for either mode after extubation (6,7). On the other hand, NIPPV is limited by asynchrony between the ventilator and patients’ spontaneous breaths, leading to diversion of air to the stomach, abdominal distension, and feed intolerance (8,9). This distention also contributes to challenges with ventilation, regional atelectasis, and prolonged respiratory requirements.

To enhance patient-ventilator synchrony, Sinderby et al. initially introduced a novel ventilatory mode known as neurally adjusted ventilatory assist (NAVA), which synchronizes respiratory support with diaphragmatic activity (10). The NAVA ventilator detects the electrical activity of the diaphragm using an esophageal probe, which also functions as a tube for feeding or removing gastric air (11). As ventilatory support is proportionate to the level of diaphragmatic activity, weaning of the ventilator occurs based on diaphragm contractility (12,13). Existing evidence shows that non-invasive NAVA (NIV-NAVA) is feasible for neonates (11,14,15) and improves diaphragmatic activity, but improvements in clinical outcomes have not been reported to date (16). The limitation of this meta-analysis is that outcomes, including BPD, intraventricular hemorrhage (IVH), pneumothorax, and mortality, were combined for primary and post-extubation respiratory support in preterm infants and not reported separately (16).

Due to the benefit of synchronization, NIV-NAVA may be a superior mode of primary or post-extubation respiratory support for preterm infants with RDS (12,17,18). Data that separately evaluates the use of NIV-NAVA as primary and post-extubation mode of respiratory support is required (16). Therefore, the aim of this study was to systematically review and meta-analyze the efficacy and safety of NIV-NAVA compared to non-invasive respiratory (nCPAP and NIPPV) modalities for primary and post-extubation respiratory support in prematurity-associated RDS. We present this article in accordance with the PRISMA (19) reporting checklist (available at https://pm.amegroups.com/article/view/10.21037/pm-25-24/rc).

Methods

We used guidelines from the Cochrane Neonatal Review Group (20) for conducting a systematic review. The review was registered with Open Science Framework (OSF) (https://osf.io/jf9ga/).

Eligibility criteria

Types of studies

Randomized controlled trials (RCTs) that compared the efficacy and safety of NIV-NAVA to NIV in primary or post-extubation respiratory support for preterm infants were included. Animal studies, case studies, retrospective studies, cross-over studies, and systematic reviews were excluded from analysis. We read editorials and reviews to identify eligible studies, but they were not included.

Participants

Infants born prematurely (less than 37 weeks of gestation) with a diagnosis of RDS were included. RDS was diagnosed by respiratory distress within hours after birth, who required respiratory support and oxygen supplementation.

Interventions and control

The intervention studied was NIV-NAVA for primary or post-extubation respiratory support of infants born preterm with RDS. The control group included non-invasive ventilation modalities (nCPAP and NIPPV).

Outcomes

The primary outcome was the need for intubation after primary respiratory support or re-intubation post-extubation respiratory support in preterm infants. Secondary outcomes were the need for surfactant therapy, the duration of invasive MV, the duration of NRS, mortality, BPD, moderate-severe BPD, culture-positive sepsis, necrotizing enterocolitis (NEC), IVH, time to full enteral feeds, and NRS-associated adverse events, including pneumothorax, feed intolerance, and nasal septal injury.

Search strategy

Embase, Medline, Cochrane Central Register of Controlled Trials (CENTRAL), and Cumulative Index of Nursing and Allied Health Literature (CINAHL) were searched from inception until November 30, 2024. P.P., B.J., and T.Y. independently conducted searches of the medical database. Language restrictions were not applied to these searches. We used the search terms and strategy depicted in Appendix 1.

Study selection

To identify potential studies for inclusion in the analysis, study abstracts were read in completion by P.P. and T.Y. Full texts of these articles were obtained and assessed by the authors for inclusion. Multiple articles that published the same data were considered as a single study to avoid duplication of data. Differences were resolved by consensus or by involving another author (B.J.).

Data extraction

P.P., T.Y., and B.J. independently extracted the data using a data collection form. Study design and outcomes were reviewed and verified by P.P., T.Y., and B.J. Any discrepancies in data were resolved by discussion until a consensus was achieved. Authors were contacted for individual patient data where relevant.

Assessment for risk of bias (ROB)

Assessment of the ROB was independently conducted by P.P., B.J., and T.Y., using the Cochrane Collaboration ROB Assessment Tool for RCTs (19). ROB was assessed for random number generation, allocation concealment, blinding of intervention and outcome assessors, completeness of follow-up, selectivity of reporting, and other potential biases. We assigned ROB as low, unclear, and high risk based on the Cochrane Collaboration guidelines. A funnel plot was used to assess publication bias (19).

Subgroup analysis

Among very low birth weight (VLBW) infants (<1,500 g), subgroup analyses of the pre-specified primary and secondary outcomes were reported.

Statistical analysis

Meta-analysis was performed using RevMan 5.3 software as part of the Cochrane Collaboration (Nordic Cochrane Centre, Copenhagen, Denmark). Forest plots were calculated using weighted scores and a random effects model (REM, Mantel-Haenszel method). We employed REM to account for variation in methodology regarding gestational age, timing of NRS initiation, NRS mode (nCPAP or NIPPV) in the control group, and practice variations between individual NICUs. Statistical heterogeneity was assessed with a χ² test and the I² statistic. A P value of <0.1 for the χ² statistic indicated significant heterogeneity. For the I² statistic, we used the following thresholds: 25% low heterogeneity, 50% moderate heterogeneity, and 75% high heterogeneity (20,21). For studies that presented data as median and interquartile range, we estimated the mean and standard deviation using minimum and maximum values, as well as the interquartile ranges (22). Means or standard deviations were combined using calculations provided by the Cochrane Handbook (20). Effect size was reported as relative risk (RR) with its 95% confidence interval (CI) or mean difference (MD) and 95% CI.

Summary of findings

Key information about the study, including certainty of evidence, details of the intervention, and summary of outcome data, were included in a table according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines. Grading of evidence was performed with the online tool GradePro GDT (23).

Ethical considerations

This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study utilized published data and did not require approval from an ethics board of research.

Results

Study selection

Based on the literature search, 471 records in Embase, 607 records in Medline, and 270 records in CINAHL were retrieved. We reviewed full texts from 15 RCTs, of which six studies met our inclusion criteria. Of the six included RCTs, three (n=183) (24-26) studied NIV-NAVA for primary respiratory support, and three studies (n=153) (27-29) focused on the post-extubation use of NIV-NAVA. Two were excluded as animal studies (17,18), six were crossover RCTs (13,30-34), and one was a trial protocol (35). The results of the search strategy are documented in Figure 1.

Figure 1 Search results from medical databases. CENTRAL, Cochrane Central Register of Controlled Trials; CINAHL, Cumulative Index of Nursing and Allied Health Literature.

Characteristics of trials

Of the six included RCTs, three (n=183) studied NIV-NAVA for primary respiratory support, and three studies (n=153) focused on the post-extubation use of NIV-NAVA. In the studies comparing NIV-NAVA for primary respiratory support, the inclusion criteria differed between studies. One study included VLBW infants (24), another study enrolled preterm infants 28–37 weeks of gestation (25), and the third study examined very preterm infants (26). Two of the studies started NIV-NAVA after stabilization on CPAP (24,25), and one study compared NIV-NAVA to CPAP immediately after birth (26). For the post-extubation studies, one study compared NIV-NAVA to CPAP post-extubation (28) and two studies compared NIV-NAVA to NIPPV (27,29). We summarized the included trials in Table 1.

ROB

Most studies had low ROB for random sequence generation (5/6, 83%), low ROB for allocation concealment (4/6, 67%). There were concerns for high ROB in the domains of blinding to study personnel (3/6, 50%) and outcome assessors (2/6, 33%). The remainder of the ROB assessment is documented in Table 2.

Primary outcome

There was no difference in the need for intubation (Figure 2A) among infants treated with NIV-NAVA for primary respiratory support in RDS compared to the control group (three RCTs, n=183; RR =0.91; 95% CI: 0.56 to 1.48; I²=0%; GRADE evidence: very low). There was also no difference in the need for re-intubation (Figure 2B) comparing NIV-NAVA to controls in the post-extubation studies (three RCTs, n=153; RR =0.66; 95% CI: 0.37 to 1.20; I²=0%; GRADE evidence: very low).

Figure 2 Forest plots of RCTs comparing NIV-NAVA with NIV. (A) Outcome: need for intubation. Comparison: NIV-NAVA versus NIV for primary respiratory support. (B) Outcome: need for re-intubation. Comparison: NIV-NAVA versus NIV for post-extubation respiratory support. (C) Outcome: moderate-severe BPD post-extubation. Comparison: NIV-NAVA versus NIV for post-extubation respiratory support. BPD, bronchopulmonary dysplasia; CI, confidence interval; M-H, Mantel-Haenszel; NIV, non-invasive ventilation; NIV-NAVA, non-invasive neurally adjusted ventilatory assist; RCT, randomized controlled trial.

Secondary outcomes

BPD

The rates of BPD were no different between NIV-NAVA and the control group for primary support in RDS (two RCTs, n=163; RR =0.43; 95% CI: 0.09 to 2.15; GRADE evidence: very low). For post-extubation, NIV-NAVA had a lower risk of moderate-severe BPD (Figure 2C) than controls (three RCTs, n=153; RR =0.58; 95% CI: 0.36 to 0.96; I²=0%; GRADE evidence: low).

Other prespecified secondary outcomes

All other prespecified secondary outcomes were no different between NIV-NAVA and the control group for primary or post-extubation respiratory support (Tables 3,4).

Subgroup analysis

Subgroup analysis was completed for infants with a birth weight less than 1,500 g in the use of primary non-invasive ventilation management of RDS. There were no differences in any outcomes between NIV-NAVA and controls with very low to low certainty of evidence (Table 3).

Certainty of evidence and summary of findings

The overall certainty of evidence for all outcomes was very low to low as described in the summary of findings tables (Tables 3,4). Using the GRADE assessment method, there were concerns for ROB due to the lack of blinding of the study personnel and outcome assessor, as these methodological details were not reported or a lack of blinding was explicitly stated. Inconsistency was present only in the domains of need for invasive MV and rates of sepsis. Imprecision, on the other hand, was present based on wide CIs. Publication bias was not evaluated, as only three RCTs for each of primary support and post-extubation were available for review.

Discussion

This systematic review and meta-analysis showed that the use of NIV-NAVA does not reduce the need for intubation compared to NRS for preterm infants in primary or post-extubation management of RDS. In addition, NIV-NAVA did not reduce the risk of BPD when used for primary support, but it lowered the risk of moderate-severe BPD when used as a post-extubation modality. There were no differences for other pre-specified outcomes in either primary or post-extubation respiratory support. All findings had very low to low certainty of evidence.

Among the post-extubation RCTs, pooled data demonstrated reduction in rates of moderate-severe BPD with NIV-NAVA. The mechanism for this result has not been fully elucidated, but there is biologic plausibility for this finding. In a rabbit model of acute lung injury, synchronized ventilation delivered by NIV-NAVA resulted in lung protection with a decrease in the inflammatory marker, interleukin 8, and less histological features of alveolar inflammation (17). Dynamic lung compliance also recovered in rabbits ventilated with NIV-NAVA compared to the control ventilation mode (17). In addition, avoidance of MV or limiting the duration in MV exposure is another possible mechanism, but we report that the need for MV was not decreased for either primary or post-extubation support. Various studies have also demonstrated that NIV-NAVA and NAVA decrease the work of breathing or unload the work on the diaphragm compared to NRS (18,36). While no data directly link this decrease in energy expenditure to improved growth and lung development, Benn et al. showed a higher z-score for weight at discharge for infants on NAVA compared to controls with no difference in BPD (37). Based on these studies, the use of NIV-NAVA may lessen inflammation and support better growth.

The risk of BPD is greatest for the lowest gestational age or birth weight infants, but meta-analyses thus far have not performed a subgroup analysis on this higher risk population. In this meta-analysis, we pooled results from VLBW infants from authors who shared their data and identified a small number of participants who received NIV-NAVA as primary support. There were no benefits in need for intubation, need for surfactant, rates of BPD, or rates of IVH for VLBW infants. The post-extubation studies consisted primarily of extremely preterm infants; thus, no subgroup outcomes were reported.

As the rates and duration of NRS exposure have risen over the past 10–15 years, a greater proportion of infants have faced abdominal distention and feed intolerance primarily due to higher level of respiratory support delivered via nCPAP and NIPPV with the intention to avoid intubation and MV. Synchronization of respiratory support not only improves work of breathing, but NAVA is expected to divert less intraluminal air as asynchrony leads to abdominal distention (8,9). To assess the benefits of NIV-NAVA on feeding outcomes, a limited number of studies have assessed time to full feeds (25,28) in addition to rates of NEC (25,27,28). Among these RCTs, no decrease in time to full feeds or clinical reduction in NEC rates were reported for primary or post-extubation support (25,27,28). However, the sample size from these studies was small.

Our findings differed from previous meta-analyses which suggested that NIV-NAVA reduced the need for re-intubation (38,39) when used for post-extubation support due to inclusion of a newer study that was not available for those meta-analyses (29). Furthermore, we observed that infants receiving NIV-NAVA for post-extubation support had lower rates of moderate-severe BPD compared to those using other non-invasive methods.

Strengths and limitations

The strength of this meta-analysis is the inclusion of subgroup analysis of primary NIV-NAVA use for VLBW neonates who are at high risk of adverse respiratory morbidities with RDS. This review, however, has several limitations. Due to a limited number of RCTs that were eligible for inclusion, our review had a small sample size of 183 and 153 participants for primary and post-extubation support, respectively, limiting the validity of these findings in the larger population. These studies also included only a small number of participants at the highest risk for BPD, infants who are born extremely premature. In addition, different modes of post-extubation support (nCPAP and NIPPV) were used, which introduces heterogeneity into the control group. We also report a high risk of detection bias due to unclear or lack of blinding for the outcome assessors in most studies (24-29). Reporting of outcomes related to feed intolerance and nasal trauma was lacking in all except for one study. Lastly, long-term neurodevelopmental and respiratory outcomes have not been reported with the use of NIV-NAVA.

Implications for future research

This meta-analysis identified a reduction in moderate to severe BPD with the use of NIV-NAVA compared to NRS for post-extubation support. Research to address this question is currently underway, as a large multicentre, adequately powered RCT is recruiting to evaluate the efficacy and safety of NIV-NAVA for post-extubation respiratory support for preterm infants with RDS (35).

Conclusions

NIV-NAVA does not decrease the need for intubation compared to NRS for preterm-associated RDS; however, it may be favorable to other modes of NRS for reduction in moderate-severe BPD post-extubation for preterm infants with RDS. Large multicentre RCTs are required to test this hypothesis.

Acknowledgments

We are grateful to Merja Kallio for generously sharing individual patient data for this meta-analysis. We would also like to acknowledge Eleni Philippopoulos (Sinai Health Systems, Library Services) for her assistance in conducting the literature search.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://pm.amegroups.com/article/view/10.21037/pm-25-24/rc

Peer Review File: Available at https://pm.amegroups.com/article/view/10.21037/pm-25-24/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://pm.amegroups.com/article/view/10.21037/pm-25-24/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study utilized published data and did not require approval from an ethics board of research.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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