. 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

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; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network

Collaborators, Affiliations

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network:
Ann R Stark, Waldemar A Carlo, Betty R Vohr, Lu Ann Papile, Shampa Saha, Charles R Bauer, William Oh, Seetha Shankaran, Jon E Tyson, Linda L Wright, W Kenneth Poole, Abhik Das, Barbara J Stoll, Avroy A Fanaroff, Sheldon B Korones, Richard A Ehrenkranz, David K Stevenson, Myriam Peralta-Carcelen, Deanne E Wilson-Costello, Henrietta S Bada, Roy J Heyne, Yvette R Johnson, Kimberly Gronsman Lee, Jean J Steichen, Alan H Jobe, Angelita M Hensman, Bonnie E Stephens, Barbara Alksninis, Bill Cashore, Dan Gingras, Regina A Gargus, Shabnam Lainwala, Theresa M Leach, Martha R Leonard, Kalida Mehta, James R Moore, Lucy Noel, Suzy Ventura, Rachel V Walden, Victoria E Watson, Ann R Stark, Kimberly Gronsman Lee, Stacy Dow, Colleen Driscoll, Kerri Fournier, Michele C Walsh, Avroy A Fanaroff, Nancy S Newman, Bonnie S Siner, Arlene Zadell, Julie DiFiore, Monika Bhola, Harriet G Friedman, Gulgun Yalcinkaya, Kurt Schibler, Vivek Narendran, Kate Bridges, Barbara Alexander, Cathy Grisby, Marcia Worley Mersmann, Holly L Mincey, Jody Hessling, Teresa L Gratton, Barbara J Stoll, Linda Black, Sheena Carter, Elisabeth Dinkins, Ellen C Hale, Judson Miller, Maureen Mulligan LaRossa, Gloria V Smikle, Linda L Wright, Betty K Hastings, Elizabeth M McClure, Krisa P Van Meurs, David K Stevenson, Barry E Fleisher, M Bethany Ball, Joan M Baran, Barbara Bentley, Lori E Bond, Ginger K Brudos, Elizabeth F Bruno, Maria Elena DeAnda, Monica Hajdena-Dawson, Jean G Kohn, Carol G Kuelper, Julie C Lee-Ancajas, Melinda S Proud, Renee P Pyle, Dharshi Sivakumar, Nicholas H St John, Namasivayam Ambalavanan, Monica V Collins, Shirley S Cosby, Vivien A Phillips, Kirstin J Bailey, Fred J Biasini, Stephanie A Chopko, Kristen C Johnston, Mary Beth Moses, Kathleen G Nelson, Cryshelle S Patterson, Julie Preskitt, Richard V Rector, Laurie Lou Smith, Sally Whitley, Maria Calejo, Alexis N Diaz, Silvia M Frade Eguaras, Wendy Griffin, Kasey Hamlin-Smith, Sylvia Hiriart-Fajardo, Elaine O Mathews, Amy Mur-Worth, LuAnn Papile, Conra Backstrom Lacy, Jean R Lowe, Pablo J Sánchez, Charles R Rosenfeld, Walid A Salhab, Abbot R Laptook, Sally S Adams, James Allen, Laura Grau, Alicia Guzman, Gaynelle Hensley, Elizabeth T Heyne, Melissa H Lepps, Linda A Madden, Melissa Martin, Nancy A Miller, Janet S Morgan, Araceli Solis, Lizette E Torres, Catherine Twell Boatman, Diana M Vasil, Kerry Wilder, Yvette R Johnson, Rebecca Bara, Richard A Ehrenkranz, Patricia Gettner, Monica Konstantino, JoAnn Poulsen, Nancy Close, Walter Gilliam, Elaine Romano

Affiliations

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.

PMID: 23992673
PMCID: PMC4120744
DOI: 10.1016/j.jpeds.2013.07.027

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

Ann R Stark et al. J Pediatr. 2014 Jan.

. 2014 Jan;164(1):34-39.e2.

doi: 10.1016/j.jpeds.2013.07.027. Epub 2013 Aug 27.

Authors

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network:
Ann R Stark, Waldemar A Carlo, Betty R Vohr, Lu Ann Papile, Shampa Saha, Charles R Bauer, William Oh, Seetha Shankaran, Jon E Tyson, Linda L Wright, W Kenneth Poole, Abhik Das, Barbara J Stoll, Avroy A Fanaroff, Sheldon B Korones, Richard A Ehrenkranz, David K Stevenson, Myriam Peralta-Carcelen, Deanne E Wilson-Costello, Henrietta S Bada, Roy J Heyne, Yvette R Johnson, Kimberly Gronsman Lee, Jean J Steichen, Alan H Jobe, Angelita M Hensman, Bonnie E Stephens, Barbara Alksninis, Bill Cashore, Dan Gingras, Regina A Gargus, Shabnam Lainwala, Theresa M Leach, Martha R Leonard, Kalida Mehta, James R Moore, Lucy Noel, Suzy Ventura, Rachel V Walden, Victoria E Watson, Ann R Stark, Kimberly Gronsman Lee, Stacy Dow, Colleen Driscoll, Kerri Fournier, Michele C Walsh, Avroy A Fanaroff, Nancy S Newman, Bonnie S Siner, Arlene Zadell, Julie DiFiore, Monika Bhola, Harriet G Friedman, Gulgun Yalcinkaya, Kurt Schibler, Vivek Narendran, Kate Bridges, Barbara Alexander, Cathy Grisby, Marcia Worley Mersmann, Holly L Mincey, Jody Hessling, Teresa L Gratton, Barbara J Stoll, Linda Black, Sheena Carter, Elisabeth Dinkins, Ellen C Hale, Judson Miller, Maureen Mulligan LaRossa, Gloria V Smikle, Linda L Wright, Betty K Hastings, Elizabeth M McClure, Krisa P Van Meurs, David K Stevenson, Barry E Fleisher, M Bethany Ball, Joan M Baran, Barbara Bentley, Lori E Bond, Ginger K Brudos, Elizabeth F Bruno, Maria Elena DeAnda, Monica Hajdena-Dawson, Jean G Kohn, Carol G Kuelper, Julie C Lee-Ancajas, Melinda S Proud, Renee P Pyle, Dharshi Sivakumar, Nicholas H St John, Namasivayam Ambalavanan, Monica V Collins, Shirley S Cosby, Vivien A Phillips, Kirstin J Bailey, Fred J Biasini, Stephanie A Chopko, Kristen C Johnston, Mary Beth Moses, Kathleen G Nelson, Cryshelle S Patterson, Julie Preskitt, Richard V Rector, Laurie Lou Smith, Sally Whitley, Maria Calejo, Alexis N Diaz, Silvia M Frade Eguaras, Wendy Griffin, Kasey Hamlin-Smith, Sylvia Hiriart-Fajardo, Elaine O Mathews, Amy Mur-Worth, LuAnn Papile, Conra Backstrom Lacy, Jean R Lowe, Pablo J Sánchez, Charles R Rosenfeld, Walid A Salhab, Abbot R Laptook, Sally S Adams, James Allen, Laura Grau, Alicia Guzman, Gaynelle Hensley, Elizabeth T Heyne, Melissa H Lepps, Linda A Madden, Melissa Martin, Nancy A Miller, Janet S Morgan, Araceli Solis, Lizette E Torres, Catherine Twell Boatman, Diana M Vasil, Kerry Wilder, Yvette R Johnson, Rebecca Bara, Richard A Ehrenkranz, Patricia Gettner, Monica Konstantino, JoAnn Poulsen, Nancy Close, Walter Gilliam, Elaine Romano

Affiliations

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.

PMID: 23992673
PMCID: PMC4120744
DOI: 10.1016/j.jpeds.2013.07.027

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.

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Comment in

Stopping the swinging pendulum of postnatal corticosteroid use.
Demauro SB, Dysart K, Kirpalani H. Demauro SB, et al. J Pediatr. 2014 Jan;164(1):9-11. doi: 10.1016/j.jpeds.2013.10.020. J Pediatr. 2014. PMID: 24359899 Free PMC article. No abstract available.

References

1. Halliday HL, Ehrenkranz RA, Doyle LW. Early postnatal (<8 days) corticosteroids for preventing chronic lung disease in preterm infants. Cochrane Database Syst Rev. 2010;(1):CD001146. - PubMed
1. Halliday HL, Ehrenkranz RA, Doyle LW. Late (>7 days) postnatal corticosteroids for chronic lung disease in preterm infants. Cochrane Database Syst Rev. 2009;(1):CD001145. - PubMed
1. American Academy of Pediatrics Committee on Fetus and Newborn. Policy statement -Postnatal corticosteroids to prevent or treat bronchopulmonary dysplasia. Pediatrics. 2010;126(2):800–8. - PubMed
1. Stark AR, Carlo WA, Tyson JE, Papile LA, Wright LL, Shankaran S, et al. Adverse effects of early dexamethasone in extremely low birth weight infants. N Engl J Med. 2001;344:95–101. - PubMed
1. Vohr BR, Wright LL, Dusick AM, Mele L, Verter J, Steichen JJ, et al. Neurodevelopmental and functional outcomes of extremely low birth weight infants in the National Institute of Child Health and Human Development Neonatal Research Network, 1993-1994. Pediatrics. 2000;105:1215–1226. - PubMed

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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

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Comment in

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical