Edoskitzea, opioideoen ondoriozko abstinentzia sindrome neonatalaren tratamendu eraginkorra?

[EUS]Helburuak: Berrikuspen bibliografiko honen helburu orokorra edoskitzea opioideekiko abstinentzia sindrome neonatalaren sintomak arintzeko eraginkorra den aztertzea izango da, eta baita honek tratamendu farmakologikoaren beharra gutxitzen duen. Bestalde, metadona hartzen duten emakume hauen esneko metadona kontzentrazioa nolakoa den eta esne honen bitartez jaioberriari heltzen zaion kantitatea nolakoa den identifikatu nahi da. Metodologia: Artikuluen bilaketa egiteko, datu base desberdinak erabili dira, baina erabilitako azken 8 artikuluak Pubmed eta Ovid-sp-ekoak dira. Artikulu guztiak bat izan ezik, ingelesezkoak dira, gaztelaniaz aurkitutako artikulu kantitate eskasa dela eta. “Edoskitzea” , “abstinentzia sindrome neonatala” eta “metadona terapia" terminoak erabili dira bilaketa prozesuan. Ondorioak: Edoskitzea opioideekiko abstinentzia sindrome neonatala jasaten duten jaioberrientzat gomendagarria dela esan daiteke, ikerketa hauen arabera, abstinentziaren sintomak eta tratamendu farmakologikoaren beharra gutxitzen baititu. Gainera, esneko metadona kontzentrazioa eta jaioberriari honen bitartez heltzen zaion kantitatea oso txikiak dira. Hala ere, lanak limitazioa garrantzitsu bat du, ikerketetako laginak txikiak izatea.

A Delphi Process to Optimize Quality and Performance of Drug Evaluation in Neonates

Background: Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently. Methodology and Main Findings: This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates. Eighty six items were initially selected and classified under 7 headings: "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6). Sixty-one items were retained and headings were rearranged after the first round, 34 were selected after the second round. A third round was required to validate 13 additional items. The final set includes 47 items divided under 5 headings. Conclusion: A set of 47 relevant criteria will help to NICUs that want to implement, conduct or participate in drug trials within a neonatal network identify important issues to be aware of. Summary Points: 1) Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. 2) The present Delphi study was conducted with an international multidisciplinary panel of 25 experts from 13 countries and aims to identify the major criteria considered necessary for selecting neonatal intensive care units (NICUs) that are able to perform drug evaluations competently. 3) Of the 86 items initially selected and classified under 7 headings - "NICUs description - Level of care'' (21), "Ability to perform drug trials: NICU organization and processes (15), "Research Experience'' (12), "Scientific competencies and area of expertise'' (8), "Quality Management'' (16), "Training and educational capacity'' (8) and "Public involvement'' (6) - 47 items were selected following a three rounds Delphi process. 4) The present consensus will help NICUs to implement, conduct or participate in drug trials within a neonatal network.