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, 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. BadaRoy J. Heyne, Yvette R. Johnson, Kimberly Gronsman Lee, Jean J. Steichen

Research output: Contribution to journalArticle

16 Citations (Scopus)

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.

Original languageEnglish (US)
JournalJournal of Pediatrics
Volume164
Issue number1
DOIs
StatePublished - Jan 2014

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Extremely Low Birth Weight Infant
Dexamethasone
Lung Diseases
Chronic Disease
Placebos
Adrenal Cortex Hormones
Weights and Measures
Neurologic Examination
Cerebral Palsy
Blindness
Growth
Child Development
Hearing Loss
Head
Incidence
Therapeutics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

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. / Stark, Ann R.; Carlo, Waldemar A.; Vohr, Betty R.; Papile, Lu Ann; Saha, Shampa; Bauer, Charles R.; Oh, William; Shankaran, Seetha; Tyson, Jon E.; Wright, Linda L.; Poole, W. Kenneth; Das, Abhik; Stoll, Barbara J.; Fanaroff, Avroy A.; Korones, Sheldon B.; Ehrenkranz, Richard A.; Stevenson, David K.; Peralta-Carcelen, Myriam; Wilson-Costello, Deanne E.; Bada, Henrietta S.; Heyne, Roy J.; Johnson, Yvette R.; Lee, Kimberly Gronsman; Steichen, Jean J.

In: Journal of Pediatrics, Vol. 164, No. 1, 01.2014.

Research output: Contribution to journalArticle

Stark, AR, Carlo, WA, Vohr, BR, Papile, LA, Saha, S, Bauer, CR, Oh, W, Shankaran, S, Tyson, JE, Wright, LL, Poole, WK, 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 2014, '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', Journal of Pediatrics, vol. 164, no. 1. https://doi.org/10.1016/j.jpeds.2013.07.027
Stark, Ann R. ; Carlo, Waldemar A. ; Vohr, Betty R. ; Papile, Lu Ann ; Saha, Shampa ; Bauer, Charles R. ; Oh, William ; Shankaran, Seetha ; Tyson, Jon E. ; Wright, Linda L. ; Poole, W. Kenneth ; Das, Abhik ; Stoll, Barbara J. ; Fanaroff, Avroy A. ; Korones, Sheldon B. ; Ehrenkranz, Richard A. ; Stevenson, David K. ; Peralta-Carcelen, Myriam ; Wilson-Costello, Deanne E. ; Bada, Henrietta S. ; Heyne, Roy J. ; Johnson, Yvette R. ; Lee, Kimberly Gronsman ; Steichen, Jean J. / 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. In: Journal of Pediatrics. 2014 ; Vol. 164, No. 1.
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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.",
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AU - Stark, Ann R.

AU - Carlo, Waldemar A.

AU - Vohr, Betty R.

AU - Papile, Lu Ann

AU - Saha, Shampa

AU - Bauer, Charles R.

AU - Oh, William

AU - Shankaran, Seetha

AU - Tyson, Jon E.

AU - Wright, Linda L.

AU - Poole, W. Kenneth

AU - Das, Abhik

AU - Stoll, Barbara J.

AU - Fanaroff, Avroy A.

AU - Korones, Sheldon B.

AU - Ehrenkranz, Richard A.

AU - Stevenson, David K.

AU - Peralta-Carcelen, Myriam

AU - Wilson-Costello, Deanne E.

AU - Bada, Henrietta S.

AU - Heyne, Roy J.

AU - Johnson, Yvette R.

AU - Lee, Kimberly Gronsman

AU - Steichen, Jean J.

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N2 - 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.

AB - 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.

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