title: 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.
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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.affiliation: Division of Neonatology, Vanderbilt University School of Medicine, Nashville, TN. Electronic address: ann.r.stark@vanderbilt.edu.
authors.forename: Ann R
authors.initials: AR
authors.lastname: Stark
authors.affiliation: Division of Neonatology, University of Alabama, Birmingham, AL.
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.affiliation: Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI.
authors.forename: Betty R
authors.initials: BR
authors.lastname: Vohr
authors.affiliation: Division of Neonatology, Indiana University School of Medicine, Indianapolis, IN.
authors.forename: Lu Ann
authors.initials: LA
authors.lastname: Papile
authors.affiliation: Statistics and Epidemiology Unit, RTI International, Research Triangle Park, NC.
authors.forename: Shampa
authors.initials: S
authors.lastname: Saha
authors.affiliation: University of Miami Miller School of Medicine, Miami, FL.
authors.forename: Charles R
authors.initials: CR
authors.lastname: Bauer
authors.affiliation: Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI.
authors.forename: William
authors.initials: W
authors.lastname: Oh
authors.affiliation: Department of Pediatrics, Wayne State University, Detroit, MI.
authors.forename: Seetha
authors.initials: S
authors.lastname: Shankaran
authors.affiliation: Department of Pediatrics, University of Texas Health Science Center, Houston, TX.
authors.forename: Jon E
authors.initials: JE
authors.lastname: Tyson
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Wright
authors.affiliation: Statistics and Epidemiology Unit, RTI International, Research Triangle Park, NC.
authors.forename: W Kenneth
authors.initials: WK
authors.lastname: Poole
authors.affiliation: Statistics and Epidemiology Unit, RTI International, Rockville, MD.
authors.forename: Abhik
authors.initials: A
authors.lastname: Das
authors.affiliation: Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA.
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Stoll
authors.affiliation: Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.
authors.forename: Avroy A
authors.initials: AA
authors.lastname: Fanaroff
authors.affiliation: Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN.
authors.forename: Sheldon B
authors.initials: SB
authors.lastname: Korones
authors.affiliation: Department of Pediatrics, Yale University School of Medicine, New Haven, CT.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Ehrenkranz
authors.affiliation: Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine and Lucille Packard Children's Hospital, Palo Alto, CA.
authors.forename: David K
authors.initials: DK
authors.lastname: Stevenson
authors.affiliation: Division of Neonatology, University of Alabama, Birmingham, AL.
authors.forename: Myriam
authors.initials: M
authors.lastname: Peralta-Carcelen
authors.affiliation: Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.
authors.forename: Deanne E
authors.initials: DE
authors.lastname: Wilson-Costello
authors.affiliation: Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN.
authors.forename: Henrietta S
authors.initials: HS
authors.lastname: Bada
authors.affiliation: Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.
authors.forename: Roy J
authors.initials: RJ
authors.lastname: Heyne
authors.affiliation: Department of Pediatrics, Baylor College of Medicine, Houston, TX.
authors.forename: Yvette R
authors.initials: YR
authors.lastname: Johnson
authors.affiliation: Department of Pediatrics, Medical University of South Carolina, Charleston, SC.
authors.forename: Kimberly Gronsman
authors.initials: KG
authors.lastname: Lee
authors.affiliation: Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.
authors.forename: Jean J
authors.initials: JJ
authors.lastname: Steichen
mesh_terms: D002423:Cause of Death / Q000639:trends; D002657:Child Development; D002908:Chronic Disease; D002658:Developmental Disabilities / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D003907:Dexamethasone / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D015994:Incidence; D007223:Infant; D052577:Infant, Extremely Low Birth Weight; D007275:Injections, Intravenous; D008171:Lung Diseases / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control*; D009460:Neurologic Examination; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D005938:Glucocorticoids; D003907:Dexamethasone
keywords: CLD; Chronic lung disease; ELBW; Extremely low birth weight; GI; Gastrointestinal; MDI; Mental Developmental Index; NDI; Neurodevelopmental impairment; PDI; Psychomotor Developmental Index