Multicenter Randomized Controlled Trial of Inhaled Nitric Oxide for Pediatric Acute Respiratory Distress Syndrome

Bronicki, Ronald A.; Fortenberry, James D.; Schreiber, Michael D; Checchia, Paul A.; Anas, Nick

doi:10.1016/j.jpeds.2014.10.011

Cited by 56 publications

(68 citation statements)

References 36 publications

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“…These results are in keeping with those of some previous studies, such as a publication by Kinsella et al[32] demonstrating decreased need for ECMO in these patients and the previously mentioned trial by Bronicki et al[30], which found decreased ECMO usage, as well as increased ventilator free days for the iNO arm. Lower usage of HFOV may be an additional mechanism for the observed decrease in duration of mechanical ventilation, as HFOV is associated with increased ventilator days[33].…”

Section: Discussionsupporting

confidence: 92%

“…Our mortality results agree with those of previous studies[4-10], though it has been argued that mortality in PARDS is usually secondary to non-pulmonary causes, making it unsurprising that improved oxygenation would have little effect on overall mortality[28]. However, previous studies did not evaluate for morbidity effects and selectively excluded certain populations of patients—such as those with immunocompromise, sepsis, and multisystem organ dysfunction—from analysis, which limits generalizability of the results to a significant portion of PICU patients[29, 30]. The largest study of iNO in PARDS to date propensity matched 521 PARDS patients who received iNO to those who did not, and found no improvement in mortality or ventilator free days[11].…”

Section: Discussionmentioning

confidence: 99%

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Association of Response to Inhaled Nitric Oxide and Duration of Mechanical Ventilation in Pediatric Acute Respiratory Distress Syndrome*

Dowell

Thomas

Yehya

2017

Pediatric Critical Care Medicine

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Objective Literature regarding appropriate use of inhaled nitric oxide (iNO) for pediatric acute respiratory distress syndrome (PARDS) is sparse. This study aims to determine if positive response to iNO is associated with decreased mortality and duration of mechanical ventilation in PARDS. Design Retrospective cohort study Setting Large pediatric academic medical center Patients or Subjects 161 children with PARDS and iNO exposure for ≥1 hour within 3 days of PARDS onset. Interventions Patients with ≥20% improvement in oxygenation index (OI) or oxygen saturation index (OSI) by 6 hours after iNO initiation were classified as “responders.” Measurements and Main Results OI, OSI, and ventilator settings were evaluated prior to iNO initiation and 1, 6, 12, and 24 hours following iNO initiation. Primary outcomes were mortality and duration of mechanical ventilation. Baseline characteristics, including severity of illness, were similar between responders and non-responders. Univariate analysis showed no difference in mortality between responders and non-responders (21% vs 21%, p=0.999). Ventilator days were significantly lower in responders (10 vs 16, p<0.001). Competing risk regression (competing risk of death) confirmed association between iNO response and successful extubation (SHR=2.11, 95% CI 1.41 to 3.17, p<0.001). Response to iNO was associated with decreased utilization of high frequency oscillatory ventilation (HFOV) and extracorporeal membrane oxygenation (ECMO), and lower hospital charges (difference in medians of $424,000). Conclusions Positive response to iNO was associated with fewer ventilator days, without change in mortality, potentially via reduced use of HFOV and ECMO. Future studies of iNO for PARDS should stratify based on oxygenation response, given the association with favorable outcomes.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Association of Response to Inhaled Nitric Oxide and Duration of Mechanical Ventilation in Pediatric Acute Respiratory Distress Syndrome*

Dowell

Thomas

Yehya

2017

Pediatric Critical Care Medicine

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“…This iNO usage practice is supported by clinical trials showing increased oxygenation without a reduction in mortality in premature babies with HRF. 16 This study safely reduced iNO usage rates with no adverse effects from iNO therapy observed in the preterm infant cohort.…”

Section: Discussionmentioning

confidence: 66%

Impact of inhaled nitric oxide stewardship programme in a neonatal intensive care unit

Ahearn

Panda

Carlisle

et al. 2019

J Paediatrics Child Health

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Aim Inhaled nitric oxide (iNO) is the most common, although expensive, therapy for persistent pulmonary hypertension of the newborn and hypoxaemic respiratory failure. With significant variation in iNO delivery practices amongst clinicians, this study aimed to assess the effectiveness of a stewardship programme in increasing clinician compliance with revised, standardised protocols and to measure the impact of compliance on iNO therapy use. Methods Initiation and weaning protocols for iNO were introduced to the neonatal intensive care unit at The Centenary Hospital on 01 March 2016. A 2‐year stewardship programme was utilised to assess protocol compliance and the resulting iNO usage impacts were measured. A combined retrospective and prospective study from 1 March 2014 to 28 February 2018 was conducted to compare the patterns of iNO utilisation between the pre‐ and post‐stewardship cohorts. Results The pre‐stewardship cohort incorporated 18 neonates, receiving 19 iNO treatment episodes, and 18 neonates, receiving 21 iNO treatment episodes, in the post‐stewardship cohort. No significant difference in patient demographics was determined. Compliance with the protocols improved from 61% in year 1 to 88% in year 2 of the stewardship programme. Significant reductions were observed in median total hours of iNO therapy per patient (P = 0.0014) and in median time from therapy initiation to initial wean (P < 0.0001). The cost of iNO therapy reduced 52% during the stewardship programme with no increase in adverse patient outcomes. Conclusion An iNO stewardship programme could be safely implemented in any NICU leading to increased protocol compliance with a beneficial reduction in iNO usage and cost.

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“…Multiple studies of iNO in adult ARDS have not shown benefit on mortality or liberation from mechanical ventilation. However, a recent study by Bronicki et al showed a decreased duration of mechanical ventilation and an increased rate of ECMO-free survival in PARDS patients who were randomized to receiving iNO (6). As a follow-up, put these results in the context of how PARDS pathophysiology differs from that of adults and also address the PALICC recommendation against the routine use of iNO in PARDS in the context of more targeted use through PARDS patient subclass stratification.…”

Section: Pards Treatmentmentioning

confidence: 99%

Editorial: ARDS: Reaching for the Horizon

2017

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Multicenter Randomized Controlled Trial of Inhaled Nitric Oxide for Pediatric Acute Respiratory Distress Syndrome

Cited by 56 publications

References 36 publications

Association of Response to Inhaled Nitric Oxide and Duration of Mechanical Ventilation in Pediatric Acute Respiratory Distress Syndrome*

Association of Response to Inhaled Nitric Oxide and Duration of Mechanical Ventilation in Pediatric Acute Respiratory Distress Syndrome*

Impact of inhaled nitric oxide stewardship programme in a neonatal intensive care unit

Editorial: ARDS: Reaching for the Horizon

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