Ann R Stark1, Waldemar A Carlo2, Betty R Vohr3, Lu Ann Papile4, Shampa Saha5, Charles R Bauer6, William Oh3, Seetha Shankaran7, Jon E Tyson8, Linda L Wright9, W Kenneth Poole5, Abhik Das10, Barbara J Stoll11, Avroy A Fanaroff12, Sheldon B Korones13, Richard A Ehrenkranz14, David K Stevenson15, Myriam Peralta-Carcelen2, Deanne E Wilson-Costello12, Henrietta S Bada13, Roy J Heyne16, Yvette R Johnson17, Kimberly Gronsman Lee18, Jean J Steichen19. 1. Division of Neonatology, Vanderbilt University School of Medicine, Nashville, TN. Electronic address: ann.r.stark@vanderbilt.edu. 2. Division of Neonatology, University of Alabama, Birmingham, AL. 3. Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI. 4. Division of Neonatology, Indiana University School of Medicine, Indianapolis, IN. 5. Statistics and Epidemiology Unit, RTI International, Research Triangle Park, NC. 6. University of Miami Miller School of Medicine, Miami, FL. 7. Department of Pediatrics, Wayne State University, Detroit, MI. 8. Department of Pediatrics, University of Texas Health Science Center, Houston, TX. 9. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. 10. Statistics and Epidemiology Unit, RTI International, Rockville, MD. 11. Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA. 12. Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH. 13. Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN. 14. Department of Pediatrics, Yale University School of Medicine, New Haven, CT. 15. Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine and Lucille Packard Children's Hospital, Palo Alto, CA. 16. Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX. 17. Department of Pediatrics, Baylor College of Medicine, Houston, TX. 18. Department of Pediatrics, Medical University of South Carolina, Charleston, SC. 19. Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.
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 earlydexamethasone 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.
RCT Entities:
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 weightinfants. 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.
Authors: Jing He; Amit Varma; Lisa A Weissfeld; Sherin U Devaskar Journal: Am J Physiol Regul Integr Comp Physiol Date: 2004-03-04 Impact factor: 3.619
Authors: Tsu F Yeh; Yuh J Lin; Hung C Lin; Chao C Huang; Wu S Hsieh; Chyi H Lin; Cheng H Tsai Journal: N Engl J Med Date: 2004-03-25 Impact factor: 91.245
Authors: Jorien M Kerstjens; Ard Nijhuis; Christian V Hulzebos; Deirdre E van Imhoff; Aleid G van Wassenaer-Leemhuis; Ingrid C van Haastert; Enrico Lopriore; Titia Katgert; Renate M Swarte; Richard A van Lingen; Twan L Mulder; Céleste R Laarman; Katerina Steiner; Peter H Dijk Journal: PLoS One Date: 2015-07-20 Impact factor: 3.240