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      Impact of early surfactant and inhaled nitric oxide therapies on outcomes in term/late preterm neonates with moderate hypoxic respiratory failure

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          Abstract

          Objective:

          We conducted a post-hoc analysis of early inhaled nitric oxide (iNO)-randomized controlled trial data to identify associations pertinent to the management of moderate hypoxic respiratory failure in term/late preterm infants.

          Study design:

          Univariate and multivariate logistic regression analyses were used to determine risk factors for the progression of respiratory failure and extracorporeal membrane oxygenation (ECMO)/death.

          Result:

          Among the 299 enrolled infants, oxygenation index (OI) <20 at enrollment (odds ratio 0.52, confidence interval (CI) 0.27 to 0.97) and surfactant use before randomization (odds ratio 0.47, CI 0.24 to 0.91) were associated with decreased ECMO/death rates. Early surfactant use for respiratory distress syndrome, perinatal aspiration syndrome and pneumonia/sepsis was associated with lower risk of ECMO/death ( P<0.001). Early iNO (OI 15 to 25) decreased the progression of respiratory failure to OI >30 ( P=0.002) and to composite outcome of OI >30 or ECMO/death ( P=0.02).

          Conclusion:

          This post-hoc analysis suggests that early use of surfactant and iNO in moderate respiratory failure is associated with improved outcomes.

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          Most cited references21

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          Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure.

          (1997)
          Neonates with pulmonary hypertension have been treated with inhaled nitric oxide because of studies suggesting that it is a selective pulmonary vasodilator. We conducted a randomized, multicenter, controlled trial to determine whether inhaled nitric oxide would reduce mortality or the initiation of extracorporeal membrane oxygenation in infants with hypoxic respiratory failure. Infants born after a gestation of > or =34 weeks who were 14 days old or less, had no structural heart disease, and required assisted ventilation and whose oxygenation index was 25 or higher on two measurements were eligible for the study. The infants were randomly assigned to receive nitric oxide at a concentration of 20 ppm or 100 percent oxygen (as a control). Infants whose partial pressure of arterial oxygen (PaO2) increased by 20 mm Hg or less after 30 minutes were studied for a response to 80-ppm nitric oxide or control gas. The 121 infants in the control group and the 114 in the nitric oxide group had similar base-line clinical characteristics. Sixty-four percent of the control group and 46 percent of the nitric oxide group died within 120 days or were treated with extracorporeal membrane oxygenation (P=0.006). Seventeen percent of the control group and 14 percent of the nitric oxide group died (P not significant), but significantly fewer in the nitric oxide group received extracorporeal membrane oxygenation (39 percent vs. 54 percent, P=0.014). The nitric oxide group had significantly greater improvement in PaO2 (increase, 58.2+/-85.2 mm Hg, vs. 9.7+/-51.7 mm Hg in the controls; P<0.001) and in the oxygenation index (a decrease of 14.1+/-21.1, vs. an increase of 0.8+/-21.1 in the controls; P<0.001). The study gas was not discontinued in any infant because of toxicity. Nitric oxide therapy reduced the use of extracorporeal membrane oxygenation, but had no apparent effect on mortality in critically ill infants with hypoxic respiratory failure.
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            Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. Clinical Inhaled Nitric Oxide Research Group.

            M Keszler, G Southgate, T Kueser … (2000)
            Inhaled nitric oxide improves gas exchange in neonates, but the efficacy of low-dose inhaled nitric oxide in reducing the need for extracorporeal membrane oxygenation has not been established. We conducted a clinical trial to determine whether low-dose inhaled nitric oxide would reduce the use of extracorporeal membrane oxygenation in neonates with pulmonary hypertension who were born after 34 weeks' gestation, were 4 days old or younger, required assisted ventilation, and had hypoxemic respiratory failure as defined by an oxygenation index of 25 or higher. The neonates who received nitric oxide were treated with 20 ppm for a maximum of 24 hours, followed by 5 ppm for no more than 96 hours. The primary end point of the study was the use of extracorporeal membrane oxygenation. Of 248 neonates enrolled, 126 were randomly assigned to the nitric oxide group and 122 to the control group. Extracorporeal membrane oxygenation was used in 78 neonates in the control group (64 percent) and in 48 neonates in the nitric oxide group (38 percent) (P=0.001). The 30-day mortality rate in the two groups was similar (8 percent in the control group and 7 percent in the nitric oxide group). Chronic lung disease developed less often in neonates treated with nitric oxide than in those in the control group (7 percent vs. 20 percent, P=0.02). The efficacy of nitric oxide was independent of the base-line oxygenation index and the primary pulmonary diagnosis. Inhaled nitric oxide reduces the extent to which extracorporeal membrane oxygenation is needed in neonates with hypoxemic respiratory failure and pulmonary hypertension.
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              Inhaled nitric oxide and persistent pulmonary hypertension of the newborn. The Inhaled Nitric Oxide Study Group.

              R Polin, Stephen F. Morin, W Zapol … (1997)
              Persistent pulmonary hypertension of the newborn causes systemic arterial hypoxemia because of increased pulmonary vascular resistance and right-to-left shunting of deoxygenated blood. Inhaled nitric oxide decreases pulmonary vascular resistance in newborns. We studied whether inhaled nitric oxide decreases severe hypoxemia in infants with persistent pulmonary hypertension. In a prospective, multicenter study, 58 full-term infants with severe hypoxemia and persistent pulmonary hypertension were randomly assigned to breathe either a control gas (nitrogen) or nitric oxide (80 parts per million), mixed with oxygen from a ventilator. If oxygenation increased after 20 minutes and systemic blood pressure did not decrease, the treatment was considered successful and was continued at lower concentrations. Otherwise, it was discontinued and alternative therapies, including extracorporeal membrane oxygenation, were used. Inhaled nitric oxide successfully doubled systemic oxygenation in 16 of 30 infants (53 percent), whereas conventional therapy without inhaled nitric oxide increased oxygenation in only 2 of 28 infants (7 percent). Long-term therapy with inhaled nitric oxide sustained systemic oxygenation in 75 percent of the infants who had initial improvement. Extracorporeal membrane oxygenation was required in 71 percent of the control group and 40 percent of the nitric oxide group (P=0.02). The number of deaths was similar in the two groups. Inhaled nitric oxide did not cause systemic hypotension or increase methemoglobin levels. Inhaled nitric oxide improves systemic oxygenation in infants with persistent pulmonary hypertension and may reduce the need for more invasive treatments.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Perinatol
                Journal ID (iso-abbrev): J Perinatol
                Title: Journal of Perinatology
                Publisher: Nature Publishing Group
                ISSN (Print): 0743-8346
                ISSN (Electronic): 1476-5543
                Publication date (Print): December 2013
                Publication date (Electronic): 18 July 2013
                Volume: 33
                Issue: 12
                Pages: 944-949
                Affiliations
                [1 ]Division of Neonatology, Department of Pediatrics, Medical College of Wisconsin , Milwaukee, WI, USA
                [2 ]Department of Pediatrics, Indiana University School of Medicine , Indianapolis, IN, USA
                [3 ]Department of Pediatrics, Stanford University , Palo Alto, CA, USA
                [4 ]Center for Health Evaluation and Outcome Sciences, St Paul's Hospital , Vancouver, BC, Canada
                [5 ]Department of Pediatrics, University of Alabama at Birmingham , Birmingham, AL, USA
                [6 ]Department of Pediatrics, University of British Columbia , Vancouver, BC, Canada
                Author notes
                [* ]Division of Neonatology, Department of Pediatrics, Children's Corporate Center Suite C410 , 999N 92 Street, Wauwatosa, WI 53226, USA. E-mail: gkonduri@ 123456mcw.edu
                Article
                Publisher Item ID: jp201383
                DOI: 10.1038/jp.2013.83
                PMC ID: 3841912
                PubMed ID: 23867958
                SO-VID: 15162c5d-6153-4eab-92f3-77ef3c1b7b68
                Copyright © Copyright © 2013 Nature America, Inc.
                License:

                This work is licensed under a Creative Commons Attribution 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by/3.0/

                History
                Date received : 24 March 2013
                Date revision received : 23 May 2013
                Date accepted : 07 June 2013
                Categories
                Subject: Original Article

                ScienceOpen disciplines: Pediatrics
                Keywords: newborn,lung disease,persistent pulmonary hypertension of the newborn,pphn,ecmo
                Data availability:
                ScienceOpen disciplines: Pediatrics
                Keywords: newborn, lung disease, persistent pulmonary hypertension of the newborn, pphn, ecmo

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