Randomized, multicenter trial of inhaled nitric oxide and high-frequency oscillatory ventilation in severe, persistent pulmonary hypertension of the newborn

Kinsella, John P.; Truog, William E.; Walsh, William F.; Goldberg, Ronald N.; Bancalari, Eduardo; Mayock, Dennis E.; Redding, Gregory J.; deLemos, Robert A.; Sardesai, Smeeta; McCurnin, Donald; Moreland, Susan G; Cutter, Gary; Abman, Steven H.

doi:10.1016/s0022-3476(97)70124-0

Cited by 516 publications

(221 citation statements)

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“…Details of management strategies are not provided, but the report suggests that survival is best achieved by caring for CDH infants at centers that have developed a standardized approach to care, with adequate numbers of CDH infants to develop expertise. 4 Literature review reveals a limited number of controlled clinical trials examining interventions that improve survival of infants with CDH; [5][6][7][8][9][10][11][12][13][14] however, several centers reporting relatively high rates of survival for CDH have described their management strategies in varying detail. [15][16][17][18][19][20][21][22][23][24][25] The objective of this report is to provide clinicians with a summary of specific details of clinical care strategies from these 'benchmark' centers.…”

Section: Introductionmentioning

confidence: 99%

Congenital diaphragmatic hernia: a systematic review and summary of best-evidence practice strategies

et al. 2007

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Objectives: Recent reports suggest that specific care strategies improve survival of infants with congenital diaphragmatic hernia (CDH). This review presents details of care from centers reporting high rates of survival among CDH infants.Study Design: We conducted a MEDLINE search (1995 to 2006) and searched all citations in the Cochrane Central Register of Controlled Trials. Studies were included if they contained reports of >20 infants with symptomatic CDH, and >75% survival of isolated CDH.Result: Thirteen reports from 11 centers met inclusion criteria. Overall survival, including infants with multiple anomalies, was 603/763 (79%; range: 69 to 93%). Survival for isolated CDH was 560/661 (85%; range: 78 to 96%). The frequency of extracorporeal membrane oxygenation (ECMO) use for isolated CDH varied widely among reporting centers 251/622 (40%; range: 11 to 61%), as did survival for infants with isolated CDH placed on ECMO: 149/206 (73%; range: 33 to 86%). There was no suggestion of benefit from use of antenatal glucocorticoids given after 34 weeks gestation or use of postnatal surfactant. Low mortality was frequently attributed to minimizing lung injury and adhering to center-specific criteria for ECMO.Conclusion: Use of strategies aimed at minimizing lung injury, tolerance of postductal acidosis and hypoxemia, and adhering to center-specific criteria for ECMO were strategies most consistently reported by successful centers. The literature lacks randomized clinical trials of these or other care strategies in this complex patient population; prospective studies of safety and long-term outcome are needed. Keywords: congenital diaphragmatic hernia; pulmonary hypertension; pulmonary hypoplasia; inhaled nitric oxide; extracorporeal membrane oxygenation; systematic review Introduction Congenital diaphragmatic hernia (CDH) is a rare malformation observed in approximately 1 in 3000 live births, with estimates of postnatal survival ranging from 50 to 70% despite advances in neonatal care. 1 The combination of pathophysiologic derangements associated with CDH, including lung hypoplasia, lung dysmaturity and pulmonary hypertension (PPHN), requires a multidisciplinary approach to care. 2,3 The complex nature of clinical management and the relatively infrequent presentation of infants with this rare malformation to single centers has lead to difficulty identifying consistent strategies for CDH management. A recent report from the Canadian Neonatal Research Network indicates better than predicted survival in Network centers, with significant improvement in the higher mortality odds strata, and 90% survival in the three centers that cared for at least 12 infants over a 22-month period. Details of management strategies are not provided, but the report suggests that survival is best achieved by caring for CDH infants at centers that have developed a standardized approach to care, with adequate numbers of CDH infants to develop expertise. 4 Literature review reveals a limited number of controlled clinical trials examining inter...

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Section: Introductionmentioning

confidence: 99%

Congenital diaphragmatic hernia: a systematic review and summary of best-evidence practice strategies

et al. 2007

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“…16 In a randomized trial, improvement in oxygenation occurred more frequently in infants with PPHN treated with HFOV plus iNO as compared to infants treated with either HFOV or iNO alone. 9 In another trial, HFJV resulted in improved oxygenation at lower mean airway pressures than required with conventional ventilation. 17 The current study is the first to compare two modes of HFV with respect to short-term outcomes in term and near-term infants treated with iNO for PPHN.…”

Section: Discussionmentioning

confidence: 97%

“…HFOV is a safe and effective rescue therapy for neonates with PPHN who fail conventional ventilation, and HFOV combined with iNO, as compared to HFOV alone or iNO combined with conventional ventilation, resulted in a greater improvement in arterial oxygenation and reduced need for ECMO. 9,10 Likewise, HFJV improves oxygenation and ventilation of infants with PPHN, as compared to conventional ventilation. 17 However, the relative effectiveness of HFOV and HFJV in the treatment of PPHN has not been well studied.…”

Section: Discussionmentioning

confidence: 99%

“…5 iNO has been shown to reduce the need for ECMO in term and near-term neonates with pulmonary hypertension. 3,4,6,7 High-frequency ventilation (HFV) has been used with increasing frequency for PPHN, 8 and when combined with iNO results in an acute rise in arterial oxygen saturation, 9 and reduces the likelihood of ECMO treatment. 10 Studies of iNO delivered by HFV have, to date, utilized high-frequency oscillatory ventilation (HFOV).…”

Section: Introductionmentioning

confidence: 99%

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Neonatal pulmonary hypertension treated with inhaled nitric oxide and high-frequency ventilation

2008

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Term and near-term infants with pulmonary hypertension are frequently treated with inhaled nitric oxide. This therapy can be delivered with highfrequency ventilation, but there has been limited study of the relative effectiveness of high-frequency jet ventilation and high-frequency oscillatory ventilation.Objective: To compare short-term clinical outcomes of neonates with pulmonary hypertension treated with inhaled nitric oxide plus either high-frequency jet ventilation or high-frequency oscillatory ventilation.Study Design: Study infants met the following criteria: X35 weeks gestation, respiratory failure with pulmonary hypertension, no congenital malformations and treatment in the first week of life with inhaled nitric oxide plus either high-frequency jet ventilation (n ¼ 22) or high-frequency oscillatory ventilation (n ¼ 43). Data were collected from medical records. Result:The jet ventilation and oscillatory ventilation groups were similar in terms of gestational age, but the jet ventilation group had less severe respiratory illness (that is, lower oxygenation index) just prior to initiation of the combination of nitric oxide and high-frequency ventilation. The jet ventilation group spent more hours on inhaled nitric oxide (71.4 versus 40.8; P ¼ 0.004) but was less likely to require extracorporeal membrane oxygenation (2(9%) versus 19(44%); P ¼ 0.004). No difference was found in the ages at which oxygen and high-frequency ventilation were discontinued. Keywords: persistent pulmonary hypertension; inhaled nitric oxide; hypoxic respiratory failure; high-frequency ventilation; high-frequency oscillatory ventilation; high-frequency jet ventilation Introduction Persistent pulmonary hypertension of the newborn (PPHN) refers to a lack of normal cardiopulmonary adaptation following delivery, 1 including persistence of the elevated pulmonary vascular resistance that is characteristic of fetuses. 2 Most often PPHN occurs in infants with meconium aspiration syndrome (34 to 51%), pneumonia/sepsis (20 to 23%), idiopathic PPHN (17 to 25%), congenital diaphragmatic hernia (10 to 15%) or respiratory distress syndrome (9 to 12%). 3,4 Prior to the introduction, in the late 1990s, of inhaled nitric oxide (iNO), therapies for PPHN included induced alkalosis, supplemental oxygen, mechanical ventilation and neuromuscular blockade; and patients who failed to respond to these measures were treated with extracorporeal membrane oxygenation (ECMO). 5 iNO has been shown to reduce the need for ECMO in term and near-term neonates with pulmonary hypertension. 3,4,6,7 High-frequency ventilation (HFV) has been used with increasing frequency for PPHN, 8 and when combined with iNO results in an acute rise in arterial oxygen saturation, 9 and reduces the likelihood of ECMO treatment. 10 Studies of iNO delivered by HFV have, to date, utilized high-frequency oscillatory ventilation (HFOV). However, since patients treated with high-frequency jet ventilation (HFJV), as compared to conventional ventilation, require lower peak pressures to achieve t...

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“…Combination of HFOV and iNO therapy is often more suc cessful than treatment with HFOV or iNO alone in patients with PPHN, especially in patients with respiratory distress syndrome or MAS as the underlying disease 31) .…”

Section: Inhaled Nitric Oxide (Ino)mentioning

confidence: 99%

Meconium Aspiration Syndrome: The Core Concept of Pathophysiology during Resuscitation

Yeh

2017

Neonatal Med

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Aspiration of meconium produces a syndrome (Meconium Aspiration Syndrome MAS) characterized by hypoxia, hypercapnia, and acidosis. Perinatal hypoxia, acute airway obstruction, pulmonary inflammation, pulmonary vasoconstriction, pulm onary hypertension, and surfactant inactivation all play a role in the pathogenesis of MAS. Most aspiration of meconium probably occurs before birth. Following aspira tion, meconium may migrate to the peripheral airway, usually take about 2 hours as demonstrated in animal experiment, leading to airway obstruction and subsequent lung inflammation and pulmonary hypertension. The presence of meconium in the endotracheal aspirate automatically establishes the diagnosis of MAS. Clinical diag nosis can be made in any infant born with meconium staining of amniotic fluid who develops respiratory distress at or shortly after birth and has positive radiographic findings. Prevention of intrauterine hypoxia, early cleaning (suctioning) of the airway, and prevention and treatment of pulmonary hypertension are essential in the mana gement of MAS. Recent studies suggest that avoidance of post term delivery may reduce the risk of intrauterine hypoxia and the incidence of MAS. Routine intrapartum naso and oropharyngeal suction does not appear to affect the incidence and outcome of MAS. Endotracheal suction at birth is considered a controversial procedure and only reserved for infants who have severe retraction at birth suggesting an upper air way obstruction. High fre quency oscillatory ventilation with nitric oxide or surfactant may improve mortality. Mortality of MAS has improved; the causes of death are relat ed primarily to hypoxic respiratory failure associated with irreversible pulmonary hypertension. Morbidity is affected mostly by perinatal hypoxia.

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Randomized, multicenter trial of inhaled nitric oxide and high-frequency oscillatory ventilation in severe, persistent pulmonary hypertension of the newborn

Cited by 516 publications

References 21 publications

Congenital diaphragmatic hernia: a systematic review and summary of best-evidence practice strategies

Congenital diaphragmatic hernia: a systematic review and summary of best-evidence practice strategies

Neonatal pulmonary hypertension treated with inhaled nitric oxide and high-frequency ventilation

Meconium Aspiration Syndrome: The Core Concept of Pathophysiology during Resuscitation

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