Antenatal corticosteroids-to-birth interval in preterm birth

Objectives: The purpose of this study was to compare short-term outcomes in children born between 24 and 34 weeks’ gestation, according to observed antenatal corticosteroids (ACS)-to-birth intervals. Research question: ‘Is there a difference in short-term outcomes between observed ACS-to-birth intervals across a range of gestational ages at birth?’ Methods: Cohort study assessing differences in incidence of short-term neonatal outcomes according to the observed interval between the last administration of ACS and birth. Linear, non-weighted GEE models with an independence working correlation structure were fitted to infant level data providing valid point estimates for either incidence or rate differences (binary outcomes) or average differences (continuous outcomes). Results: Of 886 children, 35.9% were born within 2 days after the last administration of ACS, 32.2% within 2 to 7 days, 14.1% within 8 to 14 days, and 17.8% more than 14 days after. Across gestational ages at birth, there were no differences in birth weight between children born at an ACS-to-birth interval of 7 days or less compared to more than 7 days, nor were there differences in respiratory outcomes, cerebral outcomes, or composite outcome. Conclusion: Drawing conclusions on the importance of the ACS-to-birth interval is difficult due to the post-hoc nature of the variable. In the absence of tools to better estimate if and when PTB will occur, it might not have any value in daily practice, regardless of whether there is an optimal ACS-to-birth interval or not

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

Dose rationale and pharmacokinetics of dexmedetomidine in mechanically ventilated new-borns : impact of design optimisation

Purpose: There is a need for alternative analgosedatives such as dexmedetomidine in neonates. Given the ethical and practical difficulties, protocol design for clinical trials in neonates should be carefully considered before implementation. Our objective was to identify a protocol design suitable for subsequent evaluation of the dosing requirements for dexmedetomidine in mechanically ventilated neonates. Methods: A published paediatric pharmacokinetic model was used to derive the dosing regimen for dexmedetomidine in a first-in-neonate study. Optimality criteria were applied to optimise the blood sampling schedule. The impact of sampling schedule optimisation on model parameter estimation was assessed by simulation and re-estimation procedures for different simulation scenarios. The optimised schedule was then implemented in a neonatal pilot study. Results: Parameter estimates were more precise and similarly accurate in the optimised scenarios, as compared to empirical sampling (normalised root mean square error: 1673.1% vs. 13,229.4% and relative error: 46.4% vs. 9.1%). Most importantly, protocol deviations from the optimal design still allowed reasonable parameter estimation. Data analysis from the pilot group (n = 6) confirmed the adequacy of the optimised trial protocol. Dexmedetomidine pharmacokinetics in term neonates was scaled using allometry and maturation, but results showed a 20% higher clearance in this population compared to initial estimates obtained by extrapolation from a slightly older paediatric population. Clearance for a typical neonate, with a post-menstrual age (PMA) of 40 weeks and weight 3.4 kg, was 2.92 L/h. Extension of the study with 11 additional subjects showed a further increased clearance in pre-term subjects with lower PMA. Conclusions: The use of optimal design in conjunction with simulation scenarios improved the accuracy and precision of the estimates of the parameters of interest, taking into account protocol deviations, which are often unavoidable in this event-prone population