Abstract 1150 Poster Session I, Saturday, 5/1 (poster 14)

Inhaled Nitric Oxide (INO) has been evaluated in a number of prospective trials of term and near-term neonates with hypoxic respiratory failure and has been demonstrated to improve oxygenation and reduce the occurrence of death and the need for ECMO. However before being accepted as an effective therapy for such infants, information regarding the long term neurodevelopmental outcome of infants treated with INO is urgently required. We now report the results of the long term neurodevelopmental follow-up of the infants enrolled in the NINOS trial. Infants ≥ 34 weeks gestation, age < 14 days of age, without structural heart disease or CDH, who had two oxygenation indices (OI) ≥ 25 were eligible for this trial. Infants were initially randomized to 20 ppm NO or 100% oxygen as control. Survivors were scheduled to be evaluated at 18 to 24 months of age for complete neurodevelopmental assessment. There were 235 infants enrolled in the original trial; 36 died, 20 of 121 (16.5%) control infants and 16 of 114 (14%) INO treated infants. Of the 199 surviving infants, 171 (85.9%) were evaluated at 21±3 months, 87 control infants and 84 INO treated infants. There were no significant differences in the numbers of infants rehospitalized, requiring operations, or taking regular home medications. Fewer infants treated with INO had seizures following discharge, 4.8% compared to 14.9% for control infants, but this difference was not significant. A similar number of infants in each group were sent home on oxygen and monitors, and the duration of monitoring and oxygen therapy was similar for both groups. 69 (79.3%) controls and 66 (78.6%) INO treated infants were neurologically normal. Moderate to severe cerebral palsy (CP) occurred in 13 infants, 7 control infants and 6 INO treated infants. Permanent sensorineural hearing loss occurred in 12 control infants (14.6%) and 10 INO treated infants (13.3%, NS). Eight control infants and 7 INO treated infants were fitted with hearing aids at 18-24m. There were no differences between the control vs INO groups for any of the developmental assessments including the Behavioral rating scales, the mean MDI scores 87 (±18.7) compared to 84.8 (±21.7), PDI scores 93.6 (+17.5) compared to 85.9 (±21.3), the number of children scoring greater than 2 SD below the mean (<70), and the number who were severely developmentally delayed with a score of less than 50. In addition, 29.9% of controls and 34.5% of INO children had at least 1 disability defined as CP, an MDI or PDI <70, hearing impairment or blindness (NS). INO, when used according to the protocol of the NINOS study will reduce the need for ECMO in the term and near-term hypoxic neonate and is not associated with any increase in neurodevelopmental, behavioral or medical abnormalities at 18-24 m of age in this very high risk population.