Early Inhaled Nitric Oxide Therapy for Term and Near-Term Newborn Infants with Hypoxic Respiratory Failure: Neurodevelopmental Follow-Up Journal Articles uri icon

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  • OBJECTIVE: To report the neurodevelopmental outcome of infants enrolled in a randomized multicenter trial of early inhaled nitric oxide (iNO) in term and near-term neonates with hypoxic respiratory failure and pulmonary hypertension. STUDY DESIGN: Neonates born at > or = 34 weeks gestation who required assisted ventilation and had an oxygenation index > or = 15 and < 25 were randomized to an early iNO group or a control group. A comprehensive neurodevelopmental assessment of survivors was performed at age 18 to 24 months. RESULTS: The trial enrolled 299 infants, of which 266 (89%) survived to age 18 to 24 months (136 in the early iNO group and 130 in the control group). Follow-up evaluations were done on 234 (88%) of surviving infants. There were no differences between the 2 groups in the incidence of neurodevelopmental impairment (early iNO, 27%; control, 25%) and hearing impairment (early iNO, 23%; control, 24%). Mental development index scores were similar in the 2 groups; however, psychomotor developmental index scores were significantly higher in the control group (early iNO, 89 +/- 17.7; control, 93.5 +/- 18.4). CONCLUSIONS: Early iNO therapy for hypoxic respiratory failure in term and near-term infants is not associated with an increase in neurodevelopmental impairment or hearing loss at 18 to 24 months postnatal age.


  • Konduri, G Ganesh
  • Vohr, Betty
  • Robertson, Charlene
  • Sokol, Gregory M
  • Solimano, Alfonso
  • Singer, Joel
  • Ehrenkranz, Richard A
  • Singhal, Nalini
  • Wright, Linda L
  • Van Meurs, Krisa
  • Stork, Eileen
  • Kirpalani, Haresh
  • Peliowski, Abraham
  • Johnson, Yvette

publication date

  • March 2007

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