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Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan.

ABSTRACT: Our aims were to determine the clinical impact of oral valganciclovir (VGCV) in infants aged ≤2 months with congenital cytomegalovirus (CMV) disease and evaluate the efficacy of VGCV when initiated beyond the neonatal period. The multicenter, single-arm, open-label clinical trial was conducted in Japan. Twenty-five infants aged ≤2 months with congenital CMV disease involving the central nervous system were enrolled and treated with VGCV for 6 months. The primary endpoint was the change in the whole blood CMV load before and after treatment. The secondary endpoint was the change in the auditory brainstem response (ABR) before and after treatment. Changes in ABR were assessed between the younger and older age groups (≤ and >30 days at treatment initiation). Of the 25 patients, one was excluded owing to epilepsy before VGCV administration. The median change in the CMV DNA level in whole blood was -246.0 IU/mL. The best ear and total ear assessments based on ABR were categorized as (improved + unchanged) after treatment for 100% and 93.8%, respectively. No differences in hearing efficacy were observed between the younger and older age groups. Oral VGCV is a potential therapeutic option for treating infants aged ≤2 months with congenital CMV disease.

SUBMITTER: Morioka I

PROVIDER: S-EPMC9267258 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe treatment of symptomatic congenital cytomegalovirus (CMV) disease with intravenous ganciclovir for 6 weeks has been shown to improve audiologic outcomes at 6 months, but the benefits wane over time.MethodsWe conducted a randomized, placebo-controlled trial of valganciclovir therapy in neonates with symptomatic congenital CMV disease, comparing 6 months of therapy with 6 weeks of therapy. The primary end point was the change in hearing in the better ear ("best-ear" hearing) from baseline to 6 months. Secondary end points included the change in hearing from baseline to follow-up at 12 and 24 months and neurodevelopmental outcomes, with each end point adjusted for central nervous system involvement at baseline.ResultsA total of 96 neonates underwent randomization, of whom 86 had follow-up data at 6 months that could be evaluated. Best-ear hearing at 6 months was similar in the 6-month group and the 6-week group (2 and 3 participants, respectively, had improvement; 36 and 37 had no change; and 5 and 3 had worsening; P=0.41). Total-ear hearing (hearing in one or both ears that could be evaluated) was more likely to be improved or to remain normal at 12 months in the 6-month group than in the 6-week group (73% vs. 57%, P=0.01). The benefit in total-ear hearing was maintained at 24 months (77% vs. 64%, P=0.04). At 24 months, the 6-month group, as compared with the 6-week group, had better neurodevelopmental scores on the Bayley Scales of Infant and Toddler Development, third edition, on the language-composite component (P=0.004) and on the receptive-communication scale (P=0.003). Grade 3 or 4 neutropenia occurred in 19% of the participants during the first 6 weeks. During the next 4.5 months of the study, grade 3 or 4 neutropenia occurred in 21% of the participants in the 6-month group and in 27% of those in the 6-week group (P=0.64).ConclusionsTreating symptomatic congenital CMV disease with valganciclovir for 6 months, as compared with 6 weeks, did not improve hearing in the short term but appeared to improve hearing and developmental outcomes modestly in the longer term. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00466817.).

Project description:OBJECTIVE:Complementary feeding from the age of 6 months along with breastfeeding is essential for the health of infants. The effect of educational interventions on preventing the early or late onset of complementary feeding and correcting other relevant behaviors depends on the framing of educational messages. This study aimed to compare different types of message framing on maternal behaviors in complementary feeding of infants. MATERIALS AND METHODS:This randomized controlled trial was performed on 96 mothers in three groups of 32 subjects with four-month-old infants in Isfahan (central Iran) during May-September 2018. Data were collected through self-report using a valid researcher-made questionnaire including demographic factors, knowledge, attitude, self-efficacy, and the complementary feeding related behaviors of mothers. For 4 months, the mothers received gain-framed messages in the GF group and loss-framed messages in the LF group from two different channels. The control group only received routine education. Data analysis was performed in SPSS20 using paired t-test, ANOVA, and Chi-square at the significance level of below 0.05. RESULTS:In this study, all three groups were matched in terms of demographic characteristics and mean scores of attitude, knowledge, and self-efficacy regarding the complementary feeding of their infants. Following the intervention, the mean knowledge score increased in all three groups and was more favorable in the intervention groups compared to the control group. However, no difference was observed between the GF and LF groups regarding their knowledge. In addition, the GF and LF groups were similar in terms of self-efficacy and behavior of mothers concerning the appropriate onset of complementary feeding. Meanwhile, the mean scores of attitude and behavior of mothers regarding the timely onset, diversity, and appropriateness of continuing complementary feeding were higher in the LF group compared with the GF group. CONCLUSION:Framing messages changes the attitude and knowledge and improves behaviors related to complementary feeding. The interesting point is the different impacts of different types of framing on psychological and behavioral variables. In general, loss-framed messages have more effects on the attitude and certain parts of maternal behaviors. TRIAL REGISTRATION:IRCT, IRCT20180901040919N1. Registered 29 October 2018, https://en.irct.ir/trial/33782.

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Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan.

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