Obstructieve uropathie bij kinderen voorspellende waarde van 99m Tc-DTPA renografische studies verricht tijdens maximale diurese

De volgende vraagstelling lag ten grondslag aan het in het proefschrift beschreven onderzoek: l. Is het mogelijk een niet invasieve en eenvoudige methode aan te geven an op een betrouwbare manier obstructieve hogere urinewegsystemen te ondersdheiden van niet-obstructieve urinewegsystemen? 2. Is het mogeli jk een predictieve waarde aan de onderzoeksmethode toe te kennen opdat op voorhand kan worden gesteld welke systemen baat zouden kunnen hebben bij een operatie en welke niet? 3. Is kwantificeren van de verbetering van de nierfunctie na de operatie mogelijk? Een van de belangrijkste uitgangspunten was dat de onderzoeken onder gestandaardiseerde condities moesten worden uitgevoerd wat (veelal) niet het geval was bij de in de literatuur beschreven studies. Standaardisatie zou het mogelijk rnaken de patientenstudies in de foll~ up periode te vergelijken. Er werd gekozen voor een isotopenstudie door middel van het 99mrc-D!'PA onder condities van maximale diurese, verkregen tijdens hypotone volume expansie (HVE) (27 ,28). Van deze 99mrc-D!'PA renografische studies kon op voorhand worden gesteld dat: a. het mogelijk was de functie van de nieren afzonderlijk (in percentages) vast te stellen. b. inzicht in de uro-dynamische kwaliteiten van het hogere urinewegsysteem verkregen zou worden. Deze uro-dynamische eigenschappen zijn op twee manieren bestudeerd: a. met curven over de totale nier, met andere woorden over het parenchym en het pyelum. b. met een speciale rekenmethode, genaarrd PIFI (=Parenchymal area Identifying Functional Imaging). In de loop van de studieperiode werd het duidelijk dat door een speciale procedure toe te passen gedurende de eerste 7 minuten periode van het scanonderzoek, goede informatie kon worden verkregen over de functionerende parenchymale gebieden

Renal function in neonates with twin-twin transfusion syndrome treated with or without fetoscopic laser surgery

Research into fetal development and medicin

Chronic kidney disease ten years after pediatric allogeneic hematopoietic stem cell transplantation

Chronic kidney disease (CKD) is an important sequela of hematopoietic stem cell transplantation (HSCT), but data regarding CKD after pediatric HSCT are limited. In this single center cohort study, we evaluated the estimated glomerular filtration rate (eGFR) dynamics, proteinuria and hypertension in the first decade after HSCT and assessed risk factors for CKD in 216 pediatric HSCT survivors, transplanted 2002-2012. The eGFR decreased from a median of 148 to 116 ml/min/1.73 m(2) between pre-HSCT to ten years post-HSCT. CKD (KDIGO stages G2 or A2 or more; eGFR under 90 ml/min/1.73 m(2) and/or albuminuria) occurred in 17% of patients. In multivariate analysis, severe prolonged stage 2 or more acute kidney injury (AKI), with an eGFR under 60ml/min/1.73 m(2) and duration of 28 days or more, was the main risk factor for CKD (hazard ratio 9.5, 95% confidence interval 3.4-27). Stage 2 or more AKI with an eGFR of 60ml/min/1.73 m(2) or more and KDIGO stage 2 or more AKI with eGFR under 60ml/min/1.73 m(2) but recovery within 28 days were not associated with CKD. Furthermore, hematological malignancy as HSCT indication was an independent risk factor for CKD. One third of patients had both CKD criteria, one third had isolated eGFR reduction and one third only had albuminuria. Hypertension occurred in 27% of patients with CKD compared to 4.4% of patients without. Tubular proteinuria was present in 7% of a subgroup of 71 patients with available beta 2-microglobulinuria. Thus, a significant proportion of pediatric HSCT recipients developed CKD within ten years. Our data stress the importance of structural long-term monitoring of eGFR, urine and blood pressure after HSCT to identify patients with incipient CKD who can benefit from nephroprotective interventions.Diabetes mellitus: pathophysiological changes and therap

Regulating oHigher Risk, No Direct Benefito Studies in Minors

Developmen

How Best to Define the Concept of Minimal Risk

Epidemiology in Pediatrics and Child Healt

Acceptable risks and burdens for children in research without direct benefit: a systematic analysis of the decisions made by the Dutch Central Committee

Objectives To evaluate whether the requirement of "minimal risk and burden" for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without direct benefit that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent.Developmen

Drug development for children: how adequate is the current European ethical guidance?

Epidemiology in Pediatrics and Child Healt