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J Pediatr. 2014 Jan;164(1):34-39.e2. doi: 10.1016/j.jpeds.2013.07.027. Epub 2013 Aug 27.

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.

Collaborators (147)

Stark AR, Carlo WA, Vohr BR, Papile LA, Saha S, Bauer CR, Oh W, Shankaran S, Tyson JE, Wright LL, Poole W, Das A, Stoll BJ, Fanaroff AA, Korones SB, Ehrenkranz RA, Stevenson DK, Peralta-Carcelen M, Wilson-Costello DE, Bada HS, Heyne RJ, Johnson YR, Lee KG, Steichen JJ, Jobe AH, Hensman AM, Stephens BE, Alksninis B, Cashore B, Gingras D, Gargus RA, Lainwala S, Leach TM, Leonard MR, Mehta K, Moore JR, Noel L, Ventura S, Walden RV, Watson VE, Stark AR, Lee KG, Dow S, Driscoll C, Fournier K, Walsh MC, Fanaroff AA, Newman NS, Siner BS, Zadell A, DiFiore J, Bhola M, Friedman HG, Yalcinkaya G, Schibler K, Narendran V, Bridges K, Alexander B, Grisby C, Mersmann MW, Mincey HL, Hessling J, Gratton TL, Stoll BJ, Black L, Carter S, Dinkins E, Hale EC, Miller J, LaRossa MM, Smikle GV, Wright LL, Hastings BK, McClure EM, Van Meurs KP, Stevenson DK, Fleisher BE, Ball M, Baran JM, Bentley B, Bond LE, Brudos GK, Bruno EF, DeAnda ME, Hajdena-Dawson M, Kohn JG, Kuelper CG, Lee-Ancajas JC, Proud MS, Pyle RP, Sivakumar D, John NH, Ambalavanan N, Collins MV, Cosby SS, Phillips VA, Bailey KJ, Biasini FJ, Chopko SA, Johnston KC, Moses MB, Nelson KG, Patterson CS, Preskitt J, Rector RV, Smith LL, Whitley S, Calejo M, Diaz AN, Eguaras SM, Griffin W, Hamlin-Smith K, Hiriart-Fajardo S, Mathews EO, Mur-Worth A, Papile L, Lacy CB, Lowe JR, Sánchez PJ, Rosenfeld CR, Salhab WA, Laptook AR, Adams SS, Allen J, Grau L, Guzman A, Hensley G, Heyne ET, Lepps MH, Madden LA, Martin M, Miller NA, Morgan JS, Solis A, Torres LE, Boatman CT, Vasil DM, Wilder K, Johnson YR, Bara R, Ehrenkranz RA, Gettner P, Konstantino M, Poulsen J, Close N, Gilliam W, Romano E.

Author information

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 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.

KEYWORDS:

CLD; Chronic lung disease; ELBW; Extremely low birth weight; GI; Gastrointestinal; MDI; Mental Developmental Index; NDI; Neurodevelopmental impairment; PDI; Psychomotor Developmental Index

PMID:
23992673
PMCID:
PMC4120744
DOI:
10.1016/j.jpeds.2013.07.027
[Indexed for MEDLINE]
Free PMC Article

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