Canpolat, F. E. | bioRxiv Science

bioRxiv2018

Brain volumes of very low birth weight infants measured by two dimensional cranial ultrasonography, a prospective cohort study

BackgroundCranial ultrasonography is the main neuroimaging technique for very low birth weight infants. Brain volume is a very important information about central nervous system of preterm babies.\n\nThis study aimed to evaluate brain volumes of preterm infants with two dimensional measurements of cranial ultrasonography.\n\nMethodsIntracranial height, anteroposterior diameter, bi-parietal diamater, ventricular height, thalamo-occipital distance and ventricular index measured with routine cranial ultrasonographic scanning. Brain considered a spheric, ellipsoid model and estimated absolute brain volume (EABV) calculated by substracting two lateral ventricular volumes from the total brain volume.\n\nResultsOne hundred and twenty one preterm infants under a birthweight of 1500 g and 32 weeks of gestational age included in this study. Mean gestational age of study population was 27,7 weeks, and mean birthweight was 1057 grams.\n\nTwenty two of 121 infants had dilated ventricle, in this group EABV was lower than normal group (202 {+/-} 58 cm3 vs 250 {+/-} 53 cm3, respectively, p<0.01). Advanced resuscitation, bronchopulmonary dysplasia and late onset sepsis found to be independent risk factors for low brain volume in our data.\n\nConclusionsEstimated absolute brain volume could be calculated and estimated by two dimensional measurements with transfontanel ultrasonography.

clinical trials↗

bioRxiv2018

Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): a randomised controlled trial

BackgroundThe early use of broad-spectrum antibiotics remains the cornerstone for the treatment of neonatal late onset sepsis (LOS). However, which antibiotics should be used is still debatable, as relevant studies were conducted more than 20 years ago, were single centre or country, insufficiently powered, evaluated antibiotics not in clinical use anymore and had variable inclusion/exclusion criteria and outcome measures. Moreover, antibiotic-resistant bacteria have become a major problem in many countries worldwide. We hypothesized that efficacy of meropenem as a broad spectrum antibiotic is superior to standard of care regimen (SOC) in empiric treatment of LOS and thus aimed to compare the efficacy and safety of meropenem to SOC in infants aged <90 days with LOS.\n\nMethods and findingsNeoMero-1 was a randomized, open-label, phase III superiority trial conducted in 18 neonatal units in 6 countries. Infants with post-menstrual age (PMA) of [≤]44 weeks with positive blood culture and one, or those with negative culture and at least with two predefined clinical and laboratory signs suggestive of LOS, or those with PMA >44 weeks meeting the Goldstein criteria of sepsis, were randomized in a 1:1 ratio to receive meropenem or SOC (ampicillin+gentamicin or cefotaxime+gentamicin) for 8-14 days. The primary outcome was treatment success (survival, no modification of allocated therapy, resolution/improvement of clinical and laboratory markers, no need of additional antibiotics and presumed/confirmed eradication of pathogens) at test-of-cure visit (TOC) in full analysis set. Stool samples were tested at baseline and day 28 for meropenem-resistant Gram-negative organisms (CRGNO).\n\nThe primary analysis was performed in all randomised patients (full analysis set) and in patients with culture confirmed LOS. Proportions of participants with successful outcome were compared by using a logistic regression model adjusted for the stratification factors.\n\nFrom September 3rd 2012 to November 30th 2014, in total 136 patients in each arm were randomized; 140 (52%) were culture positive. Success at TOC was achieved in 44/136 (32%) in the meropenem arm vs. 31/135 (23%) in the SOC arm (p=0.087); 17/63 (27%) vs. 10/77 (13%) in patients with positive cultures (p=0.022). The main reason of failure was modification of allocated therapy. Adverse events occurred in 72% and serious adverse events in 17% of patients, the mortality rate was 6% with no differences between study arms. Cumulative acquisition of CRGNO by day 28 occurred in 4% in the meropenem and 12% in the SOC arm (p=0.052).\n\nConclusionsMeropenem was not superior to SOC in terms of success at TOC, short term hearing disturbances, safety or mortality and did not outselect colonization with CRGNOs. Meropenem as broad-spectrum antibiotic should be reserved for neonates who are more likely to have Gram-negative LOS, especially in NICUs where microorganisms producing ESBL and AmpC beta-lactamases are circulating.

clinical trials↗