RESUMO
Introduction: The conect4children (c4c) project aims to facilitate efficient planning and delivery of paediatric clinical trials. One objective of c4c is data standardization and reuse. Interoperability and reusability of paediatric clinical trial data is challenging due to a lack of standardization. The Clinical Data Interchange Standards Consortium (CDISC) standards that are required or recommended for regulatory submissions in several countries lack paediatric specificity with limited awareness within academic institutions. To address this, c4c and CDISC collaborated to develop the Pediatrics User Guide (PUG) consisting of cross-cutting data items that are routinely collected in paediatric clinical trials, factoring in all paediatric age ranges. Methods and Results: The development of the PUG consisted of six stages. During the scoping phase, subtopics (each containing several clinically relevant concepts) were suggested and debated for inclusion in the PUG. Ninety concepts were selected for the modelling phase. Concept maps describing the Research Topic and representation procedure were developed for the 19 concepts that had no (or partial) previous modelling in CDISC. Next, metadata and implementation examples were developed for concepts. This was followed by a CDISC internal review and a public review. For both these review stages, the feedback comments were either implemented or rejected based on budget, timelines, expert review, and scope. The PUG was published on the CDISC website on February 23, 2023. Discussion: The PUG is a first step in bridging the lack of child specific CDISC standards, particularly within academia. Several academic and industrial partners were involved in the development of the PUG, and c4c has undertaken multiple steps to publicize the PUG within its academic partner organizations - in particular, the European Reference Networks (ERNs) that are developing registries and dictionaries in 24 disease areas. In the long term, continued use of the PUG in paediatric clinical trials will enable the pooling of data from multiple trials, which is particularly important for medical domains with small populations.
RESUMO
Breast-feeding initiation and continuation rates in the UK and Ireland are low relative to many European countries. As a core outcome of the prospective Cork Nutrition and Development Maternal-Infant Cohort (COMBINE) study (Cork, Ireland), we aimed to describe infant milk feeding practices in detail and examine the prevalence and impact of combination feeding of breast milk and infant formula on breast-feeding duration. COMBINE recruited 456 nulliparous mothers (2015-2017) for maternal-infant follow-up via interview at hospital discharge (median 3 (interquartile range (IQR) 2, 4) d (n 453)), 1 (n 418), 2 (n 392), 4 (n 366), 6 (n 362) and 9 (n 345) months of age. Median maternal age was 32 (IQR 29, 34) years, 97 % of mothers were of white ethnicity, 79 % were Irish-born and 75 % were college-educated. Overall, 75 % breastfed to any extent at discharge and 44 % breastfed solely. At 1, 2, 4, 6 and 9 months, respectively, 40, 36, 33, 24 and 19 % breastfed solely. Combination feeding of breast milk and infant formula was common at discharge (31 %) and 1 month (20 %). Reasons for combination feeding at 1 month included perceived/actual hunger (30 %), healthcare professional advice (31 %) and breast-feeding difficulties (13 %). Of mothers who breastfed to any extent at discharge, 45 % stopped within 4 months. Mothers who combination fed were more likely to cease breast-feeding than those who breastfed solely (relative risk 2·3 by 1 month and 12·0 by 2 months). These granular data provide valuable insight to early milk feeding practices and indicate that supporting early breast-feeding without formula use may be key to the successful continuation of breast-feeding.
