Early Inhaled Nitric Oxide Therapy for Term and Near-Term Newborn Infants with Hypoxic Respiratory Failure: Neurodevelopmental Follow-Up - 11/08/11
, Betty Vohr, MD, Charlene Robertson, MD, Gregory M. Sokol, MD, Alfonso Solimano, MD, Joel Singer, PhD, Richard A. Ehrenkranz, MD, Nalini Singhal, MD, Linda L. Wright, MD, Krisa Van Meurs, MD, Eileen Stork, MD, Haresh Kirpalani, MD, Abraham Peliowski, MD, Yvette Johnson, MDNeonatal Inhaled Nitric Oxide Study Group
Reprint requests: G. Ganesh Konduri, Associate Professor of Pediatrics, Medical College of Wisconsin, CCC Suite 410, PO Box 1997, Milwaukee, WI 53201-1997.Résumé |
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.
Le texte complet de cet article est disponible en PDF.Abbreviations : CI, CP, ECMO, iNO, MDI, OI, PDI
Plan
| All other affiliations can be found within the Appendix (available at www.jpeds.com). Supported by the National Institute of Child and Health and Human Development Neonatal Research Network (grants U10 HD21397, U10 HD40689, U10 HD21385, U10 HD21415, U10 HD21397, U10 HD27881, M01 RR00997, U10 HD27853, M01 RR08084, U10 HD27856, M01RR00750, U10 HD27871, M01RR06022, U10 HD27904, U10 HD27880, M01 RR00070, U10 HD34216, U10 HD34167, M01 RR02635, M01 RR02172, M01RR01032, and U10 HD21373) and the Canadian Institute of Health Research (grant UI 15246). Study gas and delivery devices were provided by INO Therapeutics Inc, Clinton, NJ. |
Vol 150 - N° 3
P. 235 - mars 2007 Retour au numéro
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