Early compared with delayed inhaled nitric oxide in moderately hypoxaemic neonates with respiratory failure: a randomised controlled trial

Jc, Mercier; Thébaud, Bernard; Onody, Peter; Storme, Leo; Overmeire, Bart Van; Breart, Gérard; Dehan, M; Gold, F; Doyon, F; Pons, Gérard; Dinh-Xuan, Anh Tuan; Nafa, S; Clety, Sc De; Paris-Llado, J; Dreyfuss, Jf; Truffert, Patrick; Lequien, P; Lacaze, T; Zupan,; Magny, J F; Kassis, Mondher; Voyer, M; Danan, Claude; Dassieu, Gilles; Am, Devaux; Blanc, Thierry; Ensel, P; Wroblewski, I.; Marey, C; Andrini, P; Pinquier, Didier; Farnoux, Caroline; Beaufils, F; Pauchard, J Y; Guillermet-Fromentin, C.; Menget, A; Desfreres, Luc; Ph, Jarreau; Moriette, G; Lanchier-Quiennec, C; Pommelet, C Le; Durand, P.G.; Matis, Jaqueline; Simeoni, Umberto; Françoise, M; Germain, J. F.; Jb, Gouyon; Debillon, Thierry; Rozé, J. C.; Morville, P; Bloom, M.C.; Mc, Lelong-Tissier; Fries, F.; Laloum, D; Guillois, B.; Hamon, Isabelle; Cortey, A.; Jm, Hascoët; Rayet, I; Teyssier, G; Cantagrel, S.; Chamboux-Cheliakine, C; Laugier, J; Mansir, T; I, Galpérine; Demarquez, J. L.; Jouvet, Philippe; Jugie, Myriam; Hubert, Philippe; Soupre, D; Sizun, Jacques; Huon, Catherine; Oriot, D.; Picaud, JC; Claris, Olivier; Bourgeois, J; Putet, G; Groote, Katrien De; Reempts, Patrick Van; Lecoutere, Dominiek; Clerckx, Anne; Blum, Denise; Lombet, Jacques; Rigo, J; Vanhaesebrouck, Piet; Mouraux, Thierry; Haumont, Dominique; Grossman, Daniel

doi:10.1016/s0140-6736(99)03309-7

Cited by 129 publications

(1 citation statement)

References 25 publications

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“…The first randomized placebo-controlled iNO trials were published in 1999. The results demonstrated the efficacy of iNO in improving oxygenation in HRF, but it failed to improve survival or BPD in pre-term newborns (109,110). Other randomized trials have been published with similar or contradictory results, leading to the first Cochrane review in 2010.…”

Section: Current Recommendationsmentioning

confidence: 96%

The Controversy Persists: Is There a Qualification Criterion to Utilize Inhaled Nitric Oxide in Pre-term Newborns?

et al. 2021

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Inhaled nitric oxide (iNO) use in premature newborns remains controversial among clinicians. In 2014, the American Academy of Pediatrics, Committee on Fetus and Newborn released a statement that the available data do not support routine iNO use in pre-term newborns. Despite the absence of significant benefits, 2016 California data showed that clinicians continue to utilize iNO in pre-term infants. With studies as recent as January 2017, the Cochrane review confirmed no major advantages of iNO in pre-term newborns. Still, it recognized that a subset of pre-term infants with pulmonary hypertension (PHTN) had not been separately investigated. Furthermore, recent non-randomized controlled trials have suggested that iNO may benefit specific subgroups of pre-term newborns, especially those with PHTN, prolonged rupture of membranes, and antenatal steroid exposure. Those pre-term infants who showed a clinical response to iNO had increased survival without disability. These findings underscore the need for future studies in pre-term newborns with hypoxemic respiratory failure and PHTN. This review will discuss the rationale for using iNO, controversies regarding the diagnosis of PHTN, and additional novel approaches of iNO treatment in perinatal asphyxia and neonatal resuscitation in the pre-term population < 34 weeks gestation.

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Section: Current Recommendationsmentioning

confidence: 96%

The Controversy Persists: Is There a Qualification Criterion to Utilize Inhaled Nitric Oxide in Pre-term Newborns?

et al. 2021

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Association of Early Inhaled Nitric Oxide With the Survival of Preterm Neonates With Pulmonary Hypoplasia

Ellsworth

Weaver

et al. 2018

JAMA Pediatr

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IMPORTANCE Pulmonary hypoplasia affects a very small percentage of preterm neonates, but its presence is associated with high rates of mortality. OBJECTIVE To determine whether treatment with inhaled nitric oxide during the first week of life was associated with improved in-hospital survival in a cohort of extremely preterm neonates with pulmonary hypoplasia. DESIGN, SETTING, AND PARTICIPANTS This cohort study used data from the Pediatrix Medical Group's Clinical Data Warehouse, a data set containing information from more than 350 neonatal intensive care units in 35 US states and Puerto Rico. Since inhaled nitric oxide was not randomly prescribed, we used 1-to-1 propensity score matching to reduce the imbalance of measured covariates between the 2 treatment groups. The initial, unmatched cohort included singleton neonates who were born between 22 and 29 weeks' gestation, had a birth weight of 400 g or more, were diagnosed with pulmonary hypoplasia as a cause of their respiratory distress, remained free of major anomalies, and were discharged between January 1, 2000, and December 31, 2014. We defined exposure as the initiation of inhaled nitric oxide on day t in days 0 to 7 of the life of a neonate. Each exposed neonate was matched 1-to-1 to a neonate who had not initiated inhaled nitric oxide on a given day. MAIN OUTCOMES AND MEASURES The primary outcome was mortality defined as death prior to transfer or discharge home. Secondary outcomes were any-stage necrotizing enterocolitis, retinopathy of prematurity requiring treatment, chronic lung disease, and periventricular leukomalacia. RESULTS Among 92 635 neonates in our study sample, we identified 767 (0.8%) with pulmonary hypoplasia who met all study inclusion criteria, of whom 185 (0.2%) were exposed to inhaled nitric oxide. Among 151 matched pairs of exposed and unexposed neonates, we did not identify a significant association between inhaled nitric oxide use and mortality (hazard ratio [HR], 0.79; 95% CI, 0.57-1.11). Subgroup analyses of neonates with and without persistent pulmonary hypertension (PPHN) likewise revealed no significant association between inhaled nitric oxide use and mortality (pulmonary hypoplasia with PPHN: HR, 0.67; 95% CI, 0.45-1.01; pulmonary hypoplasia without PPHN: HR, 1.11; 95% CI, 0.61-2.02), but these findings may have been influenced by ascertainment bias. CONCLUSIONS AND RELEVANCE Early treatment with inhaled nitric oxide is not associated with improved survival among extremely preterm neonates with pulmonary hypoplasia. Clinical trials are warranted to clarify the matter.

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Nitric oxide for respiratory failure in infants born at or near term

Barrington²

2001

The Cochrane Database of Systematic Reviews (Complete Reviews)

103

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Early compared with delayed inhaled nitric oxide in moderately hypoxaemic neonates with respiratory failure: a randomised controlled trial

Cited by 129 publications

References 25 publications

The Controversy Persists: Is There a Qualification Criterion to Utilize Inhaled Nitric Oxide in Pre-term Newborns?

The Controversy Persists: Is There a Qualification Criterion to Utilize Inhaled Nitric Oxide in Pre-term Newborns?

Association of Early Inhaled Nitric Oxide With the Survival of Preterm Neonates With Pulmonary Hypoplasia

Nitric oxide for respiratory failure in infants born at or near term

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