Inhaled nitric oxide in preterm infants undergoing mechanical ventilation

Roberta A. Ballard, William E. Truog, Avital Cnaan, Richard J. Martin, Philip L. Ballard, Jeffrey D. Merrill, Michele C. Walsh, David J. Durand, Dennis E. Mayock, Eric C. Eichenwald, Donald Null, Mark L. Hudak, Asha R. Puri, Sergio G. Golombek, Sherry E. Courtney, Dan L. Stewart, Stephen E. Welty, Roderic H. Phibbs, Anna Maria Hibbs, Xianqun LuanSandra R. Wadlinger, Jeanette M. Asselin, Christine E. Coburn

Research output: Contribution to journalArticle

330 Citations (Scopus)

Abstract

BACKGROUND: Bronchopulmonary dysplasia in premature infants is associated with prolonged hospitalization, as well as abnormal pulmonary and neurodevelopmental outcome. In animal models, inhaled nitric oxide improves both gas exchange and lung structural development, but the use of this therapy in infants at risk for bronchopulmonary dysplasia is controversial. METHODS: We conducted a randomized, stratified, double-blind, placebo-controlled trial of inhaled nitric oxide at 21 centers involving infants with a birth weight of 1250 g or less who required ventilatory support between 7 and 21 days of age. Treated infants received decreasing concentrations of nitric oxide, beginning at 20 ppm, for a minimum of 24 days. The primary outcome was survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age. RESULTS: Among 294 infants receiving nitric oxide and 288 receiving placebo birth weight (766 g and 759 g, respectively), gestational age (26 weeks in both groups), and other characteristics were similar. The rate of survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age was 43.9 percent in the group receiving nitric oxide and 36.8 percent in the placebo group (P=0.042). The infants who received inhaled nitric oxide were discharged sooner (P=0.04) and received supplemental oxygen therapy for a shorter time (P = 0.006). There were no short-term safety concerns. CONCLUSIONS: Inhaled nitric oxide therapy improves the pulmonary outcome for premature infants who are at risk for bronchopulmonary dysplasia when it is started between 7 and 21 days of age and has no apparent short-term adverse effects.

Original languageEnglish (US)
Pages (from-to)343-353
Number of pages11
JournalNew England Journal of Medicine
Volume355
Issue number4
DOIs
StatePublished - Jul 27 2006
Externally publishedYes

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Artificial Respiration
Premature Infants
Bronchopulmonary Dysplasia
Nitric Oxide
Placebos
Birth Weight
Lung
Gestational Age
Hospitalization
Therapeutics
Animal Models
Gases
Oxygen
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Ballard, R. A., Truog, W. E., Cnaan, A., Martin, R. J., Ballard, P. L., Merrill, J. D., ... Coburn, C. E. (2006). Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. New England Journal of Medicine, 355(4), 343-353. https://doi.org/10.1056/NEJMoa061088

Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. / Ballard, Roberta A.; Truog, William E.; Cnaan, Avital; Martin, Richard J.; Ballard, Philip L.; Merrill, Jeffrey D.; Walsh, Michele C.; Durand, David J.; Mayock, Dennis E.; Eichenwald, Eric C.; Null, Donald; Hudak, Mark L.; Puri, Asha R.; Golombek, Sergio G.; Courtney, Sherry E.; Stewart, Dan L.; Welty, Stephen E.; Phibbs, Roderic H.; Hibbs, Anna Maria; Luan, Xianqun; Wadlinger, Sandra R.; Asselin, Jeanette M.; Coburn, Christine E.

In: New England Journal of Medicine, Vol. 355, No. 4, 27.07.2006, p. 343-353.

Research output: Contribution to journalArticle

Ballard, RA, Truog, WE, Cnaan, A, Martin, RJ, Ballard, PL, Merrill, JD, Walsh, MC, Durand, DJ, Mayock, DE, Eichenwald, EC, Null, D, Hudak, ML, Puri, AR, Golombek, SG, Courtney, SE, Stewart, DL, Welty, SE, Phibbs, RH, Hibbs, AM, Luan, X, Wadlinger, SR, Asselin, JM & Coburn, CE 2006, 'Inhaled nitric oxide in preterm infants undergoing mechanical ventilation', New England Journal of Medicine, vol. 355, no. 4, pp. 343-353. https://doi.org/10.1056/NEJMoa061088
Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL, Merrill JD et al. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. New England Journal of Medicine. 2006 Jul 27;355(4):343-353. https://doi.org/10.1056/NEJMoa061088
Ballard, Roberta A. ; Truog, William E. ; Cnaan, Avital ; Martin, Richard J. ; Ballard, Philip L. ; Merrill, Jeffrey D. ; Walsh, Michele C. ; Durand, David J. ; Mayock, Dennis E. ; Eichenwald, Eric C. ; Null, Donald ; Hudak, Mark L. ; Puri, Asha R. ; Golombek, Sergio G. ; Courtney, Sherry E. ; Stewart, Dan L. ; Welty, Stephen E. ; Phibbs, Roderic H. ; Hibbs, Anna Maria ; Luan, Xianqun ; Wadlinger, Sandra R. ; Asselin, Jeanette M. ; Coburn, Christine E. / Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. In: New England Journal of Medicine. 2006 ; Vol. 355, No. 4. pp. 343-353.
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abstract = "BACKGROUND: Bronchopulmonary dysplasia in premature infants is associated with prolonged hospitalization, as well as abnormal pulmonary and neurodevelopmental outcome. In animal models, inhaled nitric oxide improves both gas exchange and lung structural development, but the use of this therapy in infants at risk for bronchopulmonary dysplasia is controversial. METHODS: We conducted a randomized, stratified, double-blind, placebo-controlled trial of inhaled nitric oxide at 21 centers involving infants with a birth weight of 1250 g or less who required ventilatory support between 7 and 21 days of age. Treated infants received decreasing concentrations of nitric oxide, beginning at 20 ppm, for a minimum of 24 days. The primary outcome was survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age. RESULTS: Among 294 infants receiving nitric oxide and 288 receiving placebo birth weight (766 g and 759 g, respectively), gestational age (26 weeks in both groups), and other characteristics were similar. The rate of survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age was 43.9 percent in the group receiving nitric oxide and 36.8 percent in the placebo group (P=0.042). The infants who received inhaled nitric oxide were discharged sooner (P=0.04) and received supplemental oxygen therapy for a shorter time (P = 0.006). There were no short-term safety concerns. CONCLUSIONS: Inhaled nitric oxide therapy improves the pulmonary outcome for premature infants who are at risk for bronchopulmonary dysplasia when it is started between 7 and 21 days of age and has no apparent short-term adverse effects.",
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T1 - Inhaled nitric oxide in preterm infants undergoing mechanical ventilation

AU - Ballard, Roberta A.

AU - Truog, William E.

AU - Cnaan, Avital

AU - Martin, Richard J.

AU - Ballard, Philip L.

AU - Merrill, Jeffrey D.

AU - Walsh, Michele C.

AU - Durand, David J.

AU - Mayock, Dennis E.

AU - Eichenwald, Eric C.

AU - Null, Donald

AU - Hudak, Mark L.

AU - Puri, Asha R.

AU - Golombek, Sergio G.

AU - Courtney, Sherry E.

AU - Stewart, Dan L.

AU - Welty, Stephen E.

AU - Phibbs, Roderic H.

AU - Hibbs, Anna Maria

AU - Luan, Xianqun

AU - Wadlinger, Sandra R.

AU - Asselin, Jeanette M.

AU - Coburn, Christine E.

PY - 2006/7/27

Y1 - 2006/7/27

N2 - BACKGROUND: Bronchopulmonary dysplasia in premature infants is associated with prolonged hospitalization, as well as abnormal pulmonary and neurodevelopmental outcome. In animal models, inhaled nitric oxide improves both gas exchange and lung structural development, but the use of this therapy in infants at risk for bronchopulmonary dysplasia is controversial. METHODS: We conducted a randomized, stratified, double-blind, placebo-controlled trial of inhaled nitric oxide at 21 centers involving infants with a birth weight of 1250 g or less who required ventilatory support between 7 and 21 days of age. Treated infants received decreasing concentrations of nitric oxide, beginning at 20 ppm, for a minimum of 24 days. The primary outcome was survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age. RESULTS: Among 294 infants receiving nitric oxide and 288 receiving placebo birth weight (766 g and 759 g, respectively), gestational age (26 weeks in both groups), and other characteristics were similar. The rate of survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age was 43.9 percent in the group receiving nitric oxide and 36.8 percent in the placebo group (P=0.042). The infants who received inhaled nitric oxide were discharged sooner (P=0.04) and received supplemental oxygen therapy for a shorter time (P = 0.006). There were no short-term safety concerns. CONCLUSIONS: Inhaled nitric oxide therapy improves the pulmonary outcome for premature infants who are at risk for bronchopulmonary dysplasia when it is started between 7 and 21 days of age and has no apparent short-term adverse effects.

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