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| |  Inhaled Nitric Oxide Use in Preterm Infants Is Not Recommended for Respiratory Failure: Presented at PAS By Sandra Distelhorst VANCOUVER -- May 4, 2010 --Use of inhaled nitric oxide (iNO) was not beneficial in treating preterm infants in respiratory failure, according to researchers here at the 2010 Pediatric Academic Societies (PAS) Annual Meeting. Neil N. Finer, MD, Division of Neonatology, University of California San Diego School of Medicine and Medical Center, San Diego, California, presented the results of the Individual Patient Data (IPD) Meta-Analysis collaboration on May 1. The intent of IPD was to determine whether iNO in preterm infants receiving assisted ventilation improves survival without morbidity and whether the effects differ depending on the risk profile of the patient. "Using individual patient data meta-analysis provides an opportunity [for] a more detailed assessment of patient-level versus trial-level characteristics and the treatment effects," said Dr. Finer. The researchers presented short-term outcomes from the study. Data from 11 trials were included in the analysis, for a total of 3,298 cases. All patients were preterm infants (<37 week gestation) receiving assisted ventilation. The infants were randomised to receive iNO or a control treatment. The primary outcome was death, which occurred in 59% of iNO-treated infants versus 61% of placebo infants (relative risk [RR] = 0.96; 95% confidence interval [CI], 0.92-1.01; P = .11). Severe neurological events seen on imaging occurred in 25% of the iNO group versus 23% of the placebo group (RR = 1.12; 95% CI, 0.98-1.28; P = .09). "Subgroup analysis was done to see if specific subgroups of patients would benefit or be disadvantaged by iNO. Statistically significant differences were seen between subgroups by age, birth weight, single or multiple birth, race, or use of antenatal steroids," said Dr. Finer. The researchers also analysed oxygen index, pulmonary hypertension, receipt of postnatal steroids, and type of ventilator, for which no statistically significant differences were found. No statistically significant differences in iNO effect were seen for any of the patient-level characteristics tested. Dose amount and protocol differed considerably in the trials, as did time of first exposure, which ranged from 4 hours to 7 days of life. In trials with a starting iNO dose >5 ppm vs <=5 ppm, evidence of improved outcome (interaction test P < .001) was seen; however, these differences were not observed with other cutpoints for dose or level of exposure to iNO. From the evaluations done to date for this individual patient data analysis, the researchers concluded that the routine use of iNO for treatment of respiratory failure in preterm infants cannot be recommended. "We did not find a particular subgroup of infants who benefited. The use of a higher iNO starting dose may be associated with improved outcome," said Dr. Finer. [Presentation title: Inhaled Nitric Oxide in Preterm Infants: An Individual Patient Data Meta-Analysis. Abstract 1172.7]
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