1. Ihlenfeld, Janet T. RN, PhD

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Konduri GG, Solimano A, Sokol GM, Singer J, Ehrenkranz RA, Singhal N, et al. for the Neonatal Inhaled Nitric Oxide Study Group. A randomized trial of early versus standard inhaled nitric oxide therapy in term and near-term newborn infants with hypoxic respiratory failure. Pediatrics. 2004;113(3):559-564.


Premature infants with deteriorating respiratory status are often treated with inhaled nitric oxide (iNO). If they continue to fail, they are subsequently treated with extracorporeal membrane oxygenation (ECMO). This study investigated whether use of iNO earlier in premature infants' therapy helped to reduce the need for ECMO treatment and consequently decrease overall mortality rates due to respiratory failure.


Infants born <34 weeks gestation were enrolled into a multisite study led by the Neonatal Inhaled Nitric Oxide Study Group. This group involved neonatal intensive care units from across the United States and Canada. Data collection occurred over a 3-year period from July 1998 to May 2001. The sample consisted of 302 infants equally distributed into treatment and control groups. Nearly one-half (42%) were in respiratory failure due to perinatal aspiration syndrome. The remaining infants had idiopathic persistent pulmonary hypertension, respiratory distress syndrome, or pneumonia with sepsis. There were no differences in the characteristics of birthweight, gender, race, type of delivery, or Apgar scores in the two groups.


Findings showed that there were no differences in deaths among the study participants between the treatment and control groups. Additionally, there were no differences in length of stay, and length of time needing oxygen and ventilator therapy. The infants in the treatment group who had the early iNO therapy had better PaO2 levels than the control infants and were weaned off their iNO earlier than the control infants. Infants having the early iNO gas had no gas-related toxic experiences. Lower doses of iNO were found to be as effective as higher doses (standard care).


The study leaders noted that because there was no difference in the overall death rates for the infants despite the findings that the iNO continued to be useful, they recommend that beginning early iNO therapy in premature infants should not become standard treatment until further study is done. Due to the increased costs of the early iNO therapy, the outcome was not cost beneficial for the infants.