OC-58Standard clinical datasets and core outcome measures; essential pre-requisites for efficient trials

• Published in: Archives of disease in childhood Vol. 102; no. Suppl 2; pp. A22 - A23
• Main Author: Haumont, Dominique
• Format: Journal Article
• Language: English
• Published: 01-06-2017
• ISSN: 0003-9888
• DOI: 10.1136/archdischild-2017-313273.58

Healthcare of newborn babies is a major issue for families and societies, as care in infancy affects health for life. The strongest tools for incremental improvement are to involve parents so that they are partners in care, promote research so that healthcare is informed by evidence, and evaluate health outcomes. Crucial to each of these aims is high quality data.One to 2% of preterm infants are born before 32 weeks of gestation or have a birth weight below 1500g. This group contributes disproportionally to the burden of mortality and morbidity related to prematurity, whether in the neonatal period or later in life. They represent the target population studied in neonatal networks.Clinical data from preterm infants are collected or recorded in numerous databases and have the power of big data. This extraordinary information is incredibly under exploited and there are many reasons to explain this. The items that are registered are not similar, or the definitions not mapped because dialogue between systems are lacking. Regulatory or security issues may refrain participation. Networks are often walled off and subject to partition because of separate leaderships. More efficiency in the use of neonatal data is a major challenge. The incredible evolution in IT which has paralleled the development of neonatal networks is an extraordinary opportunity to quit the traditional systems and move forward to a totally new approach in organising these databases in a much more efficient way.The power of IT technology opens extraordinary new perspectives in terms of speed, storing, sharing and innovative approaches in the way of caring. However, difficulties are expected with old applications which cannot evolve in the new IT environment. Security and privacy in data collection are future challenges to be addressed.In 2015 an ambitious plan to advance regulatory science for neonates was launched by creating the International Neonatal Consortium (INC), a coalition of the American Food and Drug Administration (FDA), the European Medicines Agency (EMA), other governmental agencies, the Critical Path Institute ( C-Path), industry, academia, professional organisations, neonatal networks, patient representatives and foundations. eNewborn is partner in this coalition.The original software functionalities of the eNewborn project include: interactive navigation, not limited harmonisation with other formats, linkage with other databases and strict security and privacy procedures. More than 10.000 records per year of very low birth weight and preterm infants (<1500g or<32 weeks of gestation) are already uploaded on the eNewborn platform for 2 consecutive years.