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

• Published in: The Journal of pediatrics Vol. 150; no. 3; pp. 235 - 240.e1
• Main Authors: Konduri, G. Ganesh, MD, Vohr, Betty, MD, Robertson, Charlene, MD, Sokol, Gregory M., MD, Solimano, Alfonso, MD, Singer, Joel, PhD, Ehrenkranz, Richard A., MD, Singhal, Nalini, MD, Wright, Linda L., MD, Van Meurs, Krisa, MD, Stork, Eileen, MD, Kirpalani, Haresh, MD, Peliowski, Abraham, MD, Johnson, Yvette, MD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.03.2007; Elsevier
• Subjects: Administration, Inhalation; Biological and medical sciences; Central Nervous System - growth & development; Confidence Intervals; Developmental Disabilities - diagnosis; Double-Blind Method; Female; Follow-Up Studies; General aspects; Gestational Age; Humans; Incidence; Infant; Infant, Newborn; Infant, Premature; Male; Medical sciences; Nitric Oxide - therapeutic use; Pediatrics; Pneumology; Probability; Prospective Studies; Reference Values; Respiratory Distress Syndrome, Newborn - diagnosis; Respiratory Distress Syndrome, Newborn - mortality; Respiratory Distress Syndrome, Newborn - therapy; Respiratory system : syndromes and miscellaneous diseases; Risk Assessment; Severity of Illness Index; Survival Rate; Term Birth; Treatment Outcome; ECMO; Psychomotor developmental index; Cerebral palsy; Extracorporeal membrane oxygenation; CI; iNO; CP; Oxygenation index; Confidence interval; MDI; PDI; Inhaled nitric oxide; OI; Mental developmental index; Human; Pediatrics; Therapy; Oxygen; Respiratory disease; Inhalation; Newborn; Treatment; Respiratory failure; Surveillance; Follow up study; Term pregnancy; Nitric oxide; Hypoxia; Early
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/j.jpeds.2006.11.065

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 ≥34 weeks gestation who required assisted ventilation and had an oxygenation index ≥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.