Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year

R. Scott Watson, Gilles Clermont, John P. Kinsella, Lan Kong, Robert E. Arendt, Gary Cutter, Walter T. Linde-Zwirble, Steven H. Abman, Derek C. Angus

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Abstract

BACKGROUND: The long-term consequences of inhaled nitric oxide (iNO) use in premature newborns with respiratory failure are unknown. We therefore studied the clinical and economic outcomes to 1 year of corrected age after a randomized controlled trial of prophylactic iNO. METHODS: Premature newborns (gestational age ≤34 w, birth weight 500-1250 g) with respiratory failure randomly received 5 ppm iNO or placebo within 48 h of birth until 21 d or extubation. We assessed clinical outcomes via in-person neurodevelopmental evaluation at 1 y corrected age and telephone interviews every 3 m. We estimated costs from detailed hospital bills and interviews, converting all costs to 2008 US$. Of 793 trial subjects, 631 (79.6%) contributed economic data, and 455 (77.1% of survivors) underwent neurodevelopmental evaluation. RESULTS: At 1 y corrected age, survival was not different by treatment arm (79.2% iNO vs. 74.5% placebo, P = .12), nor were other postdischarge outcomes. For subjects weighing 750-999 g, those receiving iNO had greater survival free from neurodevelopmental impairment (67.9% vs. 55.6%, P = .04). However, in subjects weighing 500-749 g, iNO led to greater oxygen dependency (11.7% vs. 4.0%, P = .04). Median total costs were similar ($235 800 iNO vs. $198 300 placebo, P = .19). Quality-adjusted survival was marginally better with iNO (by 0.011 quality-adjusted life-years/subject). The incremental cost-effectiveness ratio was $2.25 million/quality-adjusted life-year. CONCLUSIONS: Subjects in both arms commonly experienced neurodevelopmental and pulmonary morbidity, consuming substantial health care resources. Prophylactic iNO beginning in the first days of life did not lower costs and had a poor cost-effectiveness profile.

Original languageEnglish (US)
Pages (from-to)1333-1343
Number of pages11
JournalPediatrics
Volume124
Issue number5
DOIs
StatePublished - Nov 1 2009

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Respiratory Insufficiency
Nitric Oxide
Economics
Newborn Infant
Quality-Adjusted Life Years
Placebos
Costs and Cost Analysis
Cost-Benefit Analysis
Survival
Interviews
Hospital Costs
Health Resources
Birth Weight
Gestational Age
Survivors
Randomized Controlled Trials
Parturition
Oxygen
Morbidity
Delivery of Health Care

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

Cite this

Watson, R. S., Clermont, G., Kinsella, J. P., Kong, L., Arendt, R. E., Cutter, G., ... Angus, D. C. (2009). Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year. Pediatrics, 124(5), 1333-1343. https://doi.org/10.1542/peds.2009-0114
Watson, R. Scott ; Clermont, Gilles ; Kinsella, John P. ; Kong, Lan ; Arendt, Robert E. ; Cutter, Gary ; Linde-Zwirble, Walter T. ; Abman, Steven H. ; Angus, Derek C. / Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year. In: Pediatrics. 2009 ; Vol. 124, No. 5. pp. 1333-1343.
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Watson, RS, Clermont, G, Kinsella, JP, Kong, L, Arendt, RE, Cutter, G, Linde-Zwirble, WT, Abman, SH & Angus, DC 2009, 'Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year', Pediatrics, vol. 124, no. 5, pp. 1333-1343. https://doi.org/10.1542/peds.2009-0114

Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year. / Watson, R. Scott; Clermont, Gilles; Kinsella, John P.; Kong, Lan; Arendt, Robert E.; Cutter, Gary; Linde-Zwirble, Walter T.; Abman, Steven H.; Angus, Derek C.

In: Pediatrics, Vol. 124, No. 5, 01.11.2009, p. 1333-1343.

Research output: Contribution to journalArticle

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T1 - Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year

AU - Watson, R. Scott

AU - Clermont, Gilles

AU - Kinsella, John P.

AU - Kong, Lan

AU - Arendt, Robert E.

AU - Cutter, Gary

AU - Linde-Zwirble, Walter T.

AU - Abman, Steven H.

AU - Angus, Derek C.

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N2 - BACKGROUND: The long-term consequences of inhaled nitric oxide (iNO) use in premature newborns with respiratory failure are unknown. We therefore studied the clinical and economic outcomes to 1 year of corrected age after a randomized controlled trial of prophylactic iNO. METHODS: Premature newborns (gestational age ≤34 w, birth weight 500-1250 g) with respiratory failure randomly received 5 ppm iNO or placebo within 48 h of birth until 21 d or extubation. We assessed clinical outcomes via in-person neurodevelopmental evaluation at 1 y corrected age and telephone interviews every 3 m. We estimated costs from detailed hospital bills and interviews, converting all costs to 2008 US$. Of 793 trial subjects, 631 (79.6%) contributed economic data, and 455 (77.1% of survivors) underwent neurodevelopmental evaluation. RESULTS: At 1 y corrected age, survival was not different by treatment arm (79.2% iNO vs. 74.5% placebo, P = .12), nor were other postdischarge outcomes. For subjects weighing 750-999 g, those receiving iNO had greater survival free from neurodevelopmental impairment (67.9% vs. 55.6%, P = .04). However, in subjects weighing 500-749 g, iNO led to greater oxygen dependency (11.7% vs. 4.0%, P = .04). Median total costs were similar ($235 800 iNO vs. $198 300 placebo, P = .19). Quality-adjusted survival was marginally better with iNO (by 0.011 quality-adjusted life-years/subject). The incremental cost-effectiveness ratio was $2.25 million/quality-adjusted life-year. CONCLUSIONS: Subjects in both arms commonly experienced neurodevelopmental and pulmonary morbidity, consuming substantial health care resources. Prophylactic iNO beginning in the first days of life did not lower costs and had a poor cost-effectiveness profile.

AB - BACKGROUND: The long-term consequences of inhaled nitric oxide (iNO) use in premature newborns with respiratory failure are unknown. We therefore studied the clinical and economic outcomes to 1 year of corrected age after a randomized controlled trial of prophylactic iNO. METHODS: Premature newborns (gestational age ≤34 w, birth weight 500-1250 g) with respiratory failure randomly received 5 ppm iNO or placebo within 48 h of birth until 21 d or extubation. We assessed clinical outcomes via in-person neurodevelopmental evaluation at 1 y corrected age and telephone interviews every 3 m. We estimated costs from detailed hospital bills and interviews, converting all costs to 2008 US$. Of 793 trial subjects, 631 (79.6%) contributed economic data, and 455 (77.1% of survivors) underwent neurodevelopmental evaluation. RESULTS: At 1 y corrected age, survival was not different by treatment arm (79.2% iNO vs. 74.5% placebo, P = .12), nor were other postdischarge outcomes. For subjects weighing 750-999 g, those receiving iNO had greater survival free from neurodevelopmental impairment (67.9% vs. 55.6%, P = .04). However, in subjects weighing 500-749 g, iNO led to greater oxygen dependency (11.7% vs. 4.0%, P = .04). Median total costs were similar ($235 800 iNO vs. $198 300 placebo, P = .19). Quality-adjusted survival was marginally better with iNO (by 0.011 quality-adjusted life-years/subject). The incremental cost-effectiveness ratio was $2.25 million/quality-adjusted life-year. CONCLUSIONS: Subjects in both arms commonly experienced neurodevelopmental and pulmonary morbidity, consuming substantial health care resources. Prophylactic iNO beginning in the first days of life did not lower costs and had a poor cost-effectiveness profile.

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