Death or Neurodevelopmental Impairment at 18 to 22 Months Corrected Age in a Randomized Trial of Early Dexamethasone to Prevent Death or Chronic Lung Disease in Extremely Low Birth Weight Infants

• Type of Material: Article
• Authors: Ann R. Stark, Vanderbilt University; Waldemar A. Carlo, University of Alabama; Betty R. Vohr, Brown University; Lu Ann Papile, Indiana University; Shampa Saha, RTI International; Charles R. Bauer, University of Miami; Edward F. Donovan, Cincinnati Children's Hospital Medical Center; William Oh, Brown University; Seetha Shankaran, Wayne State University; Jon E. Tyson, University of Texas; Linda L. Wright, Eunice Kennedy Shriver National Institute of Child Health and Human Development; W. Kenneth Poole, RTI International; Abhik Das, RTI International; Barbara Stoll, Emory University; Avroy A. Fanaroff, Case Western Reserve University; Sheldon B. Korones, University of Tennessee; Richard A. Ehrenkranz, Yale University; David K. Stevenson, Stanford University; Myriam Peralta-Carcelen, University of Alabama; Ira Adams-Chapman, Emory University; Deanne E. Wilson-Costello, Case Western Reserve University; Henrietta S. Bada, University of Tennessee; Roy J. Heyne, University of Texas; Yvette R. Johnson, Baylor College of Medicine; Kimberly Gronsman Lee, Medical University of South Carolina; Jean J. Steichen, incinnati Children's Hospital Medical Center; Susan R. Hintz, Stanford University
• Language: English
• Date: 2014-01-01
• Publisher: MOSBY-ELSEVIER
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: ©2014 Mosby Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jpeds.2013.07.027
• Title of Journal or Parent Work: Journal of Pediatrics
• Volume: 164
• Issue: 1
• Start Page: 34
• End Page: +
• Grant/Funding Information: See publication for full funding statement.
• Keywords: RISK; Pediatrics; Life Sciences & Biomedicine; BRONCHOPULMONARY DYSPLASIA; PRETERM INFANTS; Science & Technology; CORTICOSTEROIDS; THERAPY; CEREBRAL-PALSY; FOLLOW-UP; PHARMACOKINETICS; LOW-DOSE DEXAMETHASONE; PHYSICAL GROWTH
• Research Categories: Health Sciences, Epidemiology; Biology, Neuroscience

Abstract

Objective To evaluate the incidence of death or neurodevelopmental impairment (NDI) at 18-22 months corrected age in subjects enrolled in a trial of early dexamethasone treatment to prevent death or chronic lung disease in extremely low birth weight infants. Study design Evaluation of infants at 18-22 months corrected age included anthropomorphic measurements, a standard neurological examination, and the Bayley Scales of Infant Development-II, including the Mental Developmental Index and the Psychomotor Developmental Index. NDI was defined as moderate or severe cerebral palsy, Mental Developmental Index or Psychomotor Developmental Index <70, blindness, or hearing impairment. Results Death or NDI at 18-22 months corrected age was similar in the dexamethasone and placebo groups (65% vs 66%, P =.99 among those with known outcome). The proportion of survivors with NDI was also similar, as were mean values for weight, length, and head circumference and the proportion of infants with poor growth (50% vs 41%, P =.42 for weight less than 10th percentile); 49% of infants in the placebo group received treatment with corticosteroid compared with 32% in the dexamethasone group (P =.02). Conclusion The risk of death or NDI and rate of poor growth were high but similar in the dexamethasone and placebo groups. The lack of a discernible effect of early dexamethasone on neurodevelopmental outcome may be due to frequent clinical corticosteroid use in the placebo group.