Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: A randomized, controlled trial

David W. Kimberlin, Chin Yu Lin, Pablo J. Sánchez, Gail J. Demmler, Wayne Dankner, Mark Shelton, Richard F. Jacobs, Wendy Vaudry, Robert F. Pass, Jan M. Kiell, Seng Jaw Soong, Richard J. Whitley

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559 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy and safety of ganciclovir therapy in neonates with congenital cytomegalovirus (CMV) disease. Study design: Neonates with symptomatic CMV disease involving the central nervous system were randomly assigned to receive 6 weeks of intravenous ganciclovir versus no treatment. The primary end point was improved brainstem-evoked response (BSER) between baseline and 6-month follow-up (or, for patients with normal baseline hearing, normal BSER at both time points). Results: From 1991 to 1999, 100 patients were enrolled. Of these, 42 patients had both a baseline and 6-month follow-up BSER audiometric examination and thus were evaluable for the primary end point. Twenty-one (84%) of 25 ganciclovir recipients had improved hearing or maintained normal hearing between baseline and 6 months versus 10 (59%) of 17 control patients (P = .06). None (0%) of 25 ganciclovir recipients had worsening in hearing between baseline and 6 months versus 7 (41%) of 17 control patients (P < .01). A total of 43 patients had a BSER at both baseline and at 1 year or beyond. Five (21%) of 24 ganciclovir recipients had worsening of hearing between baseline and ≥1 year versus 13 (68%) of 19 control patients (P < .01). A total of 89 patients had absolute neutrophil counts determined during the course of the study; 29 (63%) of 46 ganciclovir-treated patients had grade 3 or 4 neutropenia during treatment versus 9 (21%) of 43 control patients (P < .01). Conclusions: Ganciclovir therapy begun in the neonatal period in symptomatically infected infants with CMV infection involving the central nervous system prevents hearing deterioration at 6 months and may prevent hearing deterioration at ≥1 year. Almost two thirds of treated infants have significant neutropenia during therapy.

Original languageEnglish (US)
Pages (from-to)16-25
Number of pages10
JournalJournal of Pediatrics
Volume143
Issue number1
DOIs
StatePublished - Jul 1 2003

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Ganciclovir
Central Nervous System Diseases
Cytomegalovirus
Hearing
Randomized Controlled Trials
Brain Stem
Therapeutics
Neutropenia
Newborn Infant
Cytomegalovirus Infections
Neutrophils
Central Nervous System
Safety

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system : A randomized, controlled trial. / Kimberlin, David W.; Lin, Chin Yu; Sánchez, Pablo J.; Demmler, Gail J.; Dankner, Wayne; Shelton, Mark; Jacobs, Richard F.; Vaudry, Wendy; Pass, Robert F.; Kiell, Jan M.; Soong, Seng Jaw; Whitley, Richard J.

In: Journal of Pediatrics, Vol. 143, No. 1, 01.07.2003, p. 16-25.

Research output: Contribution to journalArticle

Kimberlin, DW, Lin, CY, Sánchez, PJ, Demmler, GJ, Dankner, W, Shelton, M, Jacobs, RF, Vaudry, W, Pass, RF, Kiell, JM, Soong, SJ & Whitley, RJ 2003, 'Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: A randomized, controlled trial', Journal of Pediatrics, vol. 143, no. 1, pp. 16-25. https://doi.org/10.1016/S0022-3476(03)00192-6
Kimberlin, David W. ; Lin, Chin Yu ; Sánchez, Pablo J. ; Demmler, Gail J. ; Dankner, Wayne ; Shelton, Mark ; Jacobs, Richard F. ; Vaudry, Wendy ; Pass, Robert F. ; Kiell, Jan M. ; Soong, Seng Jaw ; Whitley, Richard J. / Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system : A randomized, controlled trial. In: Journal of Pediatrics. 2003 ; Vol. 143, No. 1. pp. 16-25.
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abstract = "Objective: To evaluate the efficacy and safety of ganciclovir therapy in neonates with congenital cytomegalovirus (CMV) disease. Study design: Neonates with symptomatic CMV disease involving the central nervous system were randomly assigned to receive 6 weeks of intravenous ganciclovir versus no treatment. The primary end point was improved brainstem-evoked response (BSER) between baseline and 6-month follow-up (or, for patients with normal baseline hearing, normal BSER at both time points). Results: From 1991 to 1999, 100 patients were enrolled. Of these, 42 patients had both a baseline and 6-month follow-up BSER audiometric examination and thus were evaluable for the primary end point. Twenty-one (84{\%}) of 25 ganciclovir recipients had improved hearing or maintained normal hearing between baseline and 6 months versus 10 (59{\%}) of 17 control patients (P = .06). None (0{\%}) of 25 ganciclovir recipients had worsening in hearing between baseline and 6 months versus 7 (41{\%}) of 17 control patients (P < .01). A total of 43 patients had a BSER at both baseline and at 1 year or beyond. Five (21{\%}) of 24 ganciclovir recipients had worsening of hearing between baseline and ≥1 year versus 13 (68{\%}) of 19 control patients (P < .01). A total of 89 patients had absolute neutrophil counts determined during the course of the study; 29 (63{\%}) of 46 ganciclovir-treated patients had grade 3 or 4 neutropenia during treatment versus 9 (21{\%}) of 43 control patients (P < .01). Conclusions: Ganciclovir therapy begun in the neonatal period in symptomatically infected infants with CMV infection involving the central nervous system prevents hearing deterioration at 6 months and may prevent hearing deterioration at ≥1 year. Almost two thirds of treated infants have significant neutropenia during therapy.",
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T1 - Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system

T2 - A randomized, controlled trial

AU - Kimberlin, David W.

AU - Lin, Chin Yu

AU - Sánchez, Pablo J.

AU - Demmler, Gail J.

AU - Dankner, Wayne

AU - Shelton, Mark

AU - Jacobs, Richard F.

AU - Vaudry, Wendy

AU - Pass, Robert F.

AU - Kiell, Jan M.

AU - Soong, Seng Jaw

AU - Whitley, Richard J.

PY - 2003/7/1

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N2 - Objective: To evaluate the efficacy and safety of ganciclovir therapy in neonates with congenital cytomegalovirus (CMV) disease. Study design: Neonates with symptomatic CMV disease involving the central nervous system were randomly assigned to receive 6 weeks of intravenous ganciclovir versus no treatment. The primary end point was improved brainstem-evoked response (BSER) between baseline and 6-month follow-up (or, for patients with normal baseline hearing, normal BSER at both time points). Results: From 1991 to 1999, 100 patients were enrolled. Of these, 42 patients had both a baseline and 6-month follow-up BSER audiometric examination and thus were evaluable for the primary end point. Twenty-one (84%) of 25 ganciclovir recipients had improved hearing or maintained normal hearing between baseline and 6 months versus 10 (59%) of 17 control patients (P = .06). None (0%) of 25 ganciclovir recipients had worsening in hearing between baseline and 6 months versus 7 (41%) of 17 control patients (P < .01). A total of 43 patients had a BSER at both baseline and at 1 year or beyond. Five (21%) of 24 ganciclovir recipients had worsening of hearing between baseline and ≥1 year versus 13 (68%) of 19 control patients (P < .01). A total of 89 patients had absolute neutrophil counts determined during the course of the study; 29 (63%) of 46 ganciclovir-treated patients had grade 3 or 4 neutropenia during treatment versus 9 (21%) of 43 control patients (P < .01). Conclusions: Ganciclovir therapy begun in the neonatal period in symptomatically infected infants with CMV infection involving the central nervous system prevents hearing deterioration at 6 months and may prevent hearing deterioration at ≥1 year. Almost two thirds of treated infants have significant neutropenia during therapy.

AB - Objective: To evaluate the efficacy and safety of ganciclovir therapy in neonates with congenital cytomegalovirus (CMV) disease. Study design: Neonates with symptomatic CMV disease involving the central nervous system were randomly assigned to receive 6 weeks of intravenous ganciclovir versus no treatment. The primary end point was improved brainstem-evoked response (BSER) between baseline and 6-month follow-up (or, for patients with normal baseline hearing, normal BSER at both time points). Results: From 1991 to 1999, 100 patients were enrolled. Of these, 42 patients had both a baseline and 6-month follow-up BSER audiometric examination and thus were evaluable for the primary end point. Twenty-one (84%) of 25 ganciclovir recipients had improved hearing or maintained normal hearing between baseline and 6 months versus 10 (59%) of 17 control patients (P = .06). None (0%) of 25 ganciclovir recipients had worsening in hearing between baseline and 6 months versus 7 (41%) of 17 control patients (P < .01). A total of 43 patients had a BSER at both baseline and at 1 year or beyond. Five (21%) of 24 ganciclovir recipients had worsening of hearing between baseline and ≥1 year versus 13 (68%) of 19 control patients (P < .01). A total of 89 patients had absolute neutrophil counts determined during the course of the study; 29 (63%) of 46 ganciclovir-treated patients had grade 3 or 4 neutropenia during treatment versus 9 (21%) of 43 control patients (P < .01). Conclusions: Ganciclovir therapy begun in the neonatal period in symptomatically infected infants with CMV infection involving the central nervous system prevents hearing deterioration at 6 months and may prevent hearing deterioration at ≥1 year. Almost two thirds of treated infants have significant neutropenia during therapy.

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