Druggebruik tijdens de zwangerschap

De humane literatuur over dit onderwerp beperkt zich tot rapporteren van gevallen of reeksen van blootstelling aan drugs tijdens de zwangerschap. Dierexperimenteel onderzoek beperkt zich meestal tot het nagaan van teratogeniciteit en toxische effecten op korte en lange termijn. Het is dus heel moeilijk om ‘evidence based’ informatie te geven. Dit artikel is dan ook gebaseerd op literatuur en eigen ervaringen. We beperken ons tot drugs in de enge zin: alcohol en nicotine worden niet behandeld. Ook medicatie, genomen in de marge van de drugverslaving, wordt buiten beschouwing gelaten. We willen bijzondere aandacht vestigen op het gebruik van cannabis: de huidige tendens om het gebruik ervan toe te laten in welbepaalde omstandigheden kan bij de bevolking de indruk wekken dat de schadelijkheid beperkt is. Verder gaan we dieper in op de observatie van de pasgeborene voor eventuele abstinentieverschijnselen aan de hand van de Finneganscore

NEOREG : design and implementation of an online neonatal registration system to access, follow and analyse data of newborns with congenital cytomegalovirus infection

Today's registration of newborns with congenital cytomegalovirus (cCMV) infection is still performed on paper-based forms in Flanders, Belgium. This process has a large administrative impact. It is imortant that all screening tests are registered to have a complete idea of the impact of cCMV. Although these registrations are usable in computerised data analysis, these data are not available in a format to perform electronic processing. An online Neonatal Registry (NEOREG) System was designed and developed to access, follow and analyse the data of newborns remotely. It allows patients' diagnostic registration and treatment follow-up through a web interface and uses document forms in Portable Document Format (PDF), which incorporate all the elements from the existing forms. Forms are automatically processed to structured EHRs. Modules are included to perform statistical analysis. The design was driven by extendibility, security and usability requirements. The website load time, throughput and execution time of data analysis were evaluated in detail. The NEOREG system is able to replace the existing paper-based CMV records

Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): Statistical analysis plan

Background: Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth with short-term and long-term adverse consequences. Although the glucocorticoid dexamethasone has been proven to be beneficial for the prevention of BPD, there are concerns about an increased risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. The aim of the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) trial is to assess the efficacy and safety of postnatal hydrocortisone administration for the reduction of death or BPD in ventilator-dependent preterm infants. Methods/design: The SToP-BPD study is a multicentre, double-blind, placebo-controlled hydrocortisone trial in preterm infants at risk for BPD. After parental informed consent is obtained, ventilator-dependent infants are randomly allocated to hydrocortisone or placebo treatment during a 22-day period. The primary outcome measure is the composite outcome of death or BPD at 36 weeks postmenstrual age. Secondary outcomes are short-term effects on pulmonary condition and long-term neurodevelopmental sequelae assessed at 2 years corrected age. Complications of treatment, other serious adverse events and suspected unexpected serious adverse reactions are reported as safety outcomes. This pre-specified statistical analysis plan was written and submitted without knowledge of the unblinded data

Congenital Cytomegalovirus infection in Flanders : demography, management and outcome

There is an ongoing need of collecting data on perinatal management and long- term follow-up of children with congenital CMV in order to estimate the true long-term disease burden of this most common congenital infection worldwide. With the Flemish registry, a first important step is taken to achieve this goal. Further studies in a screening-based population will enhance our knowledge even more

The Effect of (Val)ganciclovir on Hearing in Congenital Cytomegalovirus: A Systematic Review

Objective To search for existing evidence of a beneficial effect of (val)ganciclovir on hearing in children with congenital cytomegalovirus (cCMV) infection and to identify future research questions. Study Design Systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, searches were performed in PUBMED, EMBASE, and WEB OF SCIENCE on December 15, 2021. Methods Studies providing ear-specific hearing results after treating children with cCMV-related hearing loss with (val)ganciclovir were retained. A meta-analysis [Peto odds ratio (OR), Review Manager 5.3] was performed to compare hearing outcome between treated and untreated children. The National Institutes of Health tool was used for quality assessment and heterogeneity was assessed with I-2 statistics. Results Eighteen studies with a total of 682 treated patients were included for the systematic review. Our meta-analysis showed that treating symptomatic children with hearing loss resulted in more hearing improvement [Peto OR 7.72, 95% confidence interval (CI) 3.08-19.34] and less hearing deterioration (Peto OR 0.23, 95% CI 0.10-0.57). Relative to an improvement and deterioration rate of 9.4% and 28.2% in an untreated group, the rate of the treated group was 44.5% and 6.3%, respectively. Conclusions There is sufficient evidence in literature to support treatment with (val)ganciclovir of children with symptomatic cCMV and hearing loss. However, still today, there is insufficient evidence of the potential beneficial role of (val)ganciclovir on hearing outcome of children with isolated hearing loss, late-onset hearing loss, and asymptomatic cCMV. The urgent need for future prospective, randomized clinical trials still exists. A standardization of definitions and treatment protocols would create uniformity in future studie

The effect of (val)ganciclovir on hearing in congenital cytomegalovirus : a systematic review

Objective: To search for existing evidence of a beneficial effect of (val)ganciclovir on hearing in children with congenital cytomegalovirus (cCMV) infection and to identify future research questions. Study Design: Systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, searches were performed in PUBMED, EMBASE, and WEB OF SCIENCE on December 15, 2021. Methods: Studies providing ear-specific hearing results after treating children with cCMV-related hearing loss with (val) ganciclovir were retained. A meta-analysis [Peto odds ratio (OR), Review Manager 5.3] was performed to compare hearing outcome between treated and untreated children. The National Institutes of Health tool was used for quality assessment and heterogeneity was assessed with I2 statistics. Results: Eighteen studies with a total of 682 treated patients were included for the systematic review. Our meta-analysis showed that treating symptomatic children with hearing loss resulted in more hearing improvement [Peto OR 7.72, 95% confidence interval (CI) 3.08–19.34] and less hearing deterioration (Peto OR 0.23, 95% CI 0.10–0.57). Relative to an improvement and deterioration rate of 9.4% and 28.2% in an untreated group, the rate of the treated group was 44.5% and 6.3%, respectively. Conclusions: There is sufficient evidence in literature to support treatment with (val)ganciclovir of children with symptomatic cCMV and hearing loss. However, still today, there is insufficient evidence of the potential beneficial role of (val)ganciclovir on hearing outcome of children with isolated hearing loss, late-onset hearing loss, and asymptomatic cCMV. The urgent need for future prospective, randomized clinical trials still exists. A standardization of definitions and treatment protocols would create uniformity in future studies