title: Oral acyclovir suppression and neurodevelopment after neonatal herpes.
abstract: BACKGROUND
  Poor neurodevelopmental outcomes and recurrences of cutaneous lesions remain unacceptably frequent among survivors of neonatal herpes simplex virus (HSV) disease.
  
  
  METHODS
  We enrolled neonates with HSV disease in two parallel, identical, double-blind, placebo-controlled studies. Neonates with central nervous system (CNS) involvement were enrolled in one study, and neonates with skin, eye, and mouth involvement only were enrolled in the other. After completing a regimen of 14 to 21 days of parenteral acyclovir, the infants were randomly assigned to immediate acyclovir suppression (300 mg per square meter of body-surface area per dose orally, three times daily for 6 months) or placebo. Cutaneous recurrences were treated with open-label episodic therapy.
  
  
  RESULTS
  A total of 74 neonates were enrolled--45 with CNS involvement and 29 with skin, eye, and mouth disease. The Mental Development Index of the Bayley Scales of Infant Development (in which scores range from 50 to 150, with a mean of 100 and with higher scores indicating better neurodevelopmental outcomes) was assessed in 28 of the 45 infants with CNS involvement (62%) at 12 months of age. After adjustment for covariates, infants with CNS involvement who had been randomly assigned to acyclovir suppression had significantly higher mean Bayley mental-development scores at 12 months than did infants randomly assigned to placebo (88.24 vs. 68.12, P=0.046). Overall, there was a trend toward more neutropenia in the acyclovir group than in the placebo group (P=0.09).
  
  
  CONCLUSIONS
  Infants surviving neonatal HSV disease with CNS involvement had improved neurodevelopmental outcomes when they received suppressive therapy with oral acyclovir for 6 months. (Funded by the National Institute of Allergy and Infectious Diseases; CASG 103 and CASG 104 ClinicalTrials.gov numbers, NCT00031460 and NCT00031447, respectively.).
authors: Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL 35233, USA. dkimberlin@peds.uab.edu
authors: David W
authors: DW
authors: Kimberlin
authors: Richard J
authors: RJ
authors: Whitley
authors: Wen
authors: W
authors: Wan
authors: Dwight A
authors: DA
authors: Powell
authors: Gregory
authors: G
authors: Storch
authors: Amina
authors: A
authors: Ahmed
authors: April
authors: A
authors: Palmer
authors: Pablo J
authors: PJ
authors: Sánchez
authors: Richard F
authors: RF
authors: Jacobs
authors: John S
authors: JS
authors: Bradley
authors: Joan L
authors: JL
authors: Robinson
authors: Mark
authors: M
authors: Shelton
authors: Penelope H
authors: PH
authors: Dennehy
authors: Charles
authors: C
authors: Leach
authors: Mobeen
authors: M
authors: Rathore
authors: Nazha
authors: N
authors: Abughali
authors: Peter
authors: P
authors: Wright
authors: Lisa M
authors: LM
authors: Frenkel
authors: Rebecca C
authors: RC
authors: Brady
authors: Russell
authors: R
authors: Van Dyke
authors: Leonard B
authors: LB
authors: Weiner
authors: Judith
authors: J
authors: Guzman-Cottrill
authors: Carol A
authors: CA
authors: McCarthy
authors: Jill
authors: J
authors: Griffin
authors: Penelope
authors: P
authors: Jester
authors: Misty
authors: M
authors: Parker
authors: Fred D
authors: FD
authors: Lakeman
authors: Huichien
authors: H
authors: Kuo
authors: Choo Hyung
authors: CH
authors: Lee
authors: Gretchen A
authors: GA
authors: Cloud
mesh_terms: D000212:Acyclovir / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002493:Central Nervous System Diseases / Q000188:drug therapy* / Q000517:prevention & control / Q000821:virology; D002657:Child Development / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D006561:Herpes Simplex / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D007231:Infant, Newborn; D053208:Kaplan-Meier Estimate; D008297:Male; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D055502:Secondary Prevention
chemical_list: D000998:Antiviral Agents; D000212:Acyclovir