OBJECTIVE: To determine the medical and neurodevelopmental outcome of children with moderately severe persistent pulmonary hypertension of the newborn (PPHN) treated with or without inhaled nitric oxide (I-NO). STUDY DESIGN:Term infants with PPHN and a baseline oxygenation index of 24 +/- 9 at study entry were randomly assigned to early treatment with placebo or initial doses of I-NO (5, 20, and 80 ppm). Outcome was measured at approximately 1 year by frequency of hospitalization, growth, and neurodevelopmental and audiologic evaluation. RESULTS: Of 155 children enrolled, 144 survived, and there was follow-up for 133. No significant differences between the placebo and the I-NO groups were seen in any long-term outcome. Rehospitalization occurred in 22%, and growth did not differ. The composite neurodevelopment and audiologic outcome showed impairment in 46% of the infants. There were major neurologic abnormalities in 13%, cognitive delays in 30%, and hearing loss in 19% of the infants. CONCLUSIONS: Moderately severe PPHN at 24 hours after birth is associated with high rates of rehospitalization and disability at 1 year. Adverse outcomes were the same in I-NO and control groups.
RCT Entities:
OBJECTIVE: To determine the medical and neurodevelopmental outcome of children with moderately severe persistent pulmonary hypertension of the newborn (PPHN) treated with or without inhaled nitric oxide (I-NO). STUDY DESIGN: Term infants with PPHN and a baseline oxygenation index of 24 +/- 9 at study entry were randomly assigned to early treatment with placebo or initial doses of I-NO (5, 20, and 80 ppm). Outcome was measured at approximately 1 year by frequency of hospitalization, growth, and neurodevelopmental and audiologic evaluation. RESULTS: Of 155 children enrolled, 144 survived, and there was follow-up for 133. No significant differences between the placebo and the I-NO groups were seen in any long-term outcome. Rehospitalization occurred in 22%, and growth did not differ. The composite neurodevelopment and audiologic outcome showed impairment in 46% of the infants. There were major neurologic abnormalities in 13%, cognitive delays in 30%, and hearing loss in 19% of the infants. CONCLUSIONS: Moderately severe PPHN at 24 hours after birth is associated with high rates of rehospitalization and disability at 1 year. Adverse outcomes were the same in I-NO and control groups.
Authors: Deepthi Alapati; Zubair H Aghai; Md Jobayer Hossain; Daniel R Dirnberger; Mark T Ogino; Thomas H Shaffer Journal: Pediatr Crit Care Med Date: 2017-07 Impact factor: 3.624