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Centre for Evidence-
Based Medicine

Hypoxic Respiratory Failure in Term Infants: Inhaled nitric oxide reduces the need for ECMO.

Clinical Bottom Line

Use of inhaled nitric oxide in term infants with hypoxic respiratory failure will reduce need for ECMO (NNT = 7).

Citation

The Neonatal Inhaled Nitric Oxide Study Group. Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure. N Engl J Med 1997; 336: 597-604.

Clinical Question

In a term infant with hypoxic respiratory failure, does the use of inhaled nitric oxide decrease the need for ECMO?

Search Terms

Best Evidence: nitric oxide.

The Study

  • Double-blinded concealed randomised controlled trial with intention-to-treat.
  • The Study Patients: Infants born at 34 gestational age or greater who were 14 days of age or less. Infants required ventilation for hypoxic respiratory failure with oxygenation index greater than 25 on two consecutive measurements.
  • Control group (N = 121; 121 analysed): Treatment with 100% oxygen.
  • Experimental group (N = 114; 114 analysed): Standard care plus nitric oxide 20 ppm with a maximal increase to 80 ppm if only partial response (PaO2 increase by 20 or less) to 20 ppm nitric oxide.

The Evidence

Outcome Time to Outcome CER EER RRR ARR NNT
Death by 120 days of age or need for ECMO. 0.636 0.456 28% 0.180 6
95% Confidence Intervals 9% to 48% 0.055 to 0.305 4 to 19
Death by 120 days of age. 0.165 0.165 15% 0.025 40
95% Confidence Intervals: -40% to 71% -0.067 to 0.117 NNT = 9 to INF;
NNH = 15 to INF
Need for ECMO. 0.545 0.386 29% 0.159 7
95% Confidence Intervals: 6% to 52% 0.033 to 0.285 4 to 31

Particular to my patient:

Outcome f NNT
Death by 120 days of age or need for ECMO. 1 6
Death by 120 days of age. 1 40
Need for ECMO. 1 7

Comments

  1. Study stopped early due to proven efficacy a scheduled interim analysis.
  2. Although inhaled nitric oxide reduced the need for ECMO, it did not decrease mortality.

Appraised By

Aaron Chiu
Department of Pediatrics and Child Health
University of Manitoba; 27 January 1999
Email: chiua@cc.umanitoba.ca

Expiry Date

December 31, 2000