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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. 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. 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.

The conect4children (c4c) initiative was established to facilitate the development of new drugs and other therapies for paediatric patients. It is widely recognised that there are not enough medicines tested for all relevant ages of the paediatric population. To overcome this, it is imperative that clinical data from different sources are interoperable and can be pooled for larger post hoc studies. c4c has collaborated with the Clinical Data Interchange Standards Consortium (CDISC) to develop cross-cutting data resources that build on existing CDISC standards in an effort to standardise paediatric data. The natural next step was an extension to disease-specific data items. c4c brought together several existing initiatives and resources relevant to disease-specific data and analysed their use for standardising disease-specific data in clinical trials. Several case studies that combined disease-specific data from multiple trials have demonstrated the need for disease-specific data standardisation. We identified three relevant initiatives. These include European Reference Networks, European Joint Programme on Rare Diseases, and Pistoia Alliance. Other resources reviewed were National Cancer Institute Enterprise Vocabulary Services, CDISC standards, pharmaceutical company-specific data dictionaries, Human Phenotype Ontology, Phenopackets, Unified Registry for Inherited Metabolic Disorders, Orphacodes, Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP), and Observational Medical Outcomes Partnership. The collaborative partners associated with these resources were also reviewed briefly. A plan of action focussed on collaboration was generated for standardising disease-specific paediatric clinical trial data. A paediatric data standards multistakeholder and multi-project user group was established to guide the remaining actions—FAIRification of metadata, a Phenopackets pilot with RDCA-DAP, applying Orphacodes to case report forms of clinical trials, introducing CDISC standards into European Reference Networks, testing of the CDISC Pediatric User Guide using data from the mentioned resources and organisation of further workshops and educational materials.

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.

Recognised as the optimum infant feeding method, breastfeeding affords substantial health benefits to mother and infant. Exclusive breastfeeding is recommended to 6 months, with continuation thereafter. In Ireland, data indicates that 60% breastfeed to any extent at hospital discharge and 40% do so at 3 months. However, nationally collected data is limited in detail, particularly with regard to breastfeeding continuation. The ongoing Cork-based COMBINE birth cohort study recruited 456 participants between 2015 and 2017. Through interviewer-led questionnaires, research midwives collected feeding data at hospital discharge, 1, 2, 4, 6 and 9 months of age. Infant feeding was classed as breast (breastmilk as main milk source), combination (both breastmilk and infant formula daily) or infant formula only feeding. Adherence to the World Health Organisation (WHO) recommendation to exclusively breastfeed (breastmilk only, no infant formula, supplementary fluids or solid foods) was examined longitudinally. To explore secular changes, breastfeeding rates in COMBINE were compared to the BASELINE birth cohort study, which recruited participants (n = 2116) between 2008 and 2011 in the same setting. In COMBINE, 75% of mothers provided any breastmilk (breast or combination) at hospital discharge, of whom 44% breastfed only. Two-fifths (40%), one-third (33%) and one-quarter (24%) breastfed at 1, 4 and 6 months, respectively. Combination feeding of breastmilk and infant formula was prevalent at discharge (31%) and 1 month (20%). Advice from healthcare professionals (31%) and concern baby was hungry (30%) were commonly reported reasons for this practice and throughout the study, mothers who combination fed were more likely to stop breastfeeding altogether than those who breastfed (all P < 0.001). Infant formula only feeding increased from 25% at discharge to 40% at 1 month, 49% at 2 months and 74% at 9 months. Half (45%) of mothers who breastfed did so for less than 4 months and insufficient milk/growth faltering was the most commonly cited reason for cessation (27%). The rate of WHO-defined exclusive breastfeeding was 40% from birth to discharge, 22% to 1 month, 15% to 4 months and 2% to 6 months. The breastfeeding (breastmilk as main milk source) rate at discharge did not differ between our two birth cohorts (44 vs. 40%, P = 0.23), but was significantly higher in COMBINE compared to BASELINE at 2 (36 vs. 27%) and 6 (24 vs. 12%) months (both P < 0.05). While these data provide evidence of some progress towards longer breastfeeding durations, there remains much scope to improve infant feeding practices in Ireland.

The high prevalence of maternal deficiency and the low vitamin D content of breastmilk places newborns and infants at particular risk of vitamin D deficiency. In response to an increase in the incidence of nutritional rickets, the Food Safety Authority of Ireland published an interim infant vitamin D supplementation policy in 2007, which was implemented by the Health Service Executive in Ireland in May 2010. This recommends that all infants be given a 5μg exclusive vitamin D3 supplement daily from birth to 12 months. As adherence is not monitored nationally and the policy has not been evaluated, the aim of this study was to conduct a detailed evaluation of supplementation practices across two maternal-infant cohort studies. Data from the prospective BASELINE (recruited 2008–2011) and COMBINE (recruited 2015–2017) birth cohorts, based in Cork, Ireland, were used to examine supplementation practices. After supplementation policy implementation, BASELINE collected vitamin D supplement use data (n = 1528) at 2, 6 and 12 months. In COMBINE, 7 study visits from birth to 12 months allowed continuous collection of detailed longitudinal supplementation data in 364 participants. Use of supplemental vitamin D was higher in COMBINE than BASELINE at 2 (93 vs. 49%), 6 (89 vs. 64%) and 12 (72 vs. 44%) months (all P < 0.001). In COMBINE, 92% initiated vitamin D supplementation at birth and the median supplementation duration was 51 (40, 52) weeks, although there was a wide range (3–52 weeks). 94% of COMBINE parents used a vitamin D3 only supplement and 88% used the recommended 5μg dose. Half (51%) always supplemented daily; a further 33% supplemented at least 3–6 times/week. Full policy adherence was defined as the provision of a 5μg vitamin D3 supplement daily from birth; 64% adhered fully to 2 months and 52% did so to 6 months. By 12 months, 30% had adhered fully to the policy and a further 16% gave 5μg frequently for the full 12 months. This data indicates a high level of awareness of the supplementation policy amongst new mothers, with substantially higher rates of supplementation in our current cohort compared with BASELINE. While most parents gave an exclusive 5μg vitamin D3 supplement, frequency and duration were the key barriers to full policy adherence. Given the lack of a maternal vitamin D supplementation policy in Ireland and high prevalence of low vitamin D status at birth, supplementation of infants with vitamin D remains a vital public health policy.

Health care in Low and Middle Income Countries (LMICs) is facing a major challenge in terms of developiong a sustainable financial model; leading to difficulties such as poor retention of professional staff, fragmented and uncoordinated patient information; further exacerbated by limited national funds. Mobile Health (mHealth) potentially offers a low-cost solution to overcome some of these challenges. To date, there is a dearth of research regarding the cost-effectiveness of mHealth solutions in LMICs. As an exemplar case study, this paper introduces the World Health Organisation (WHO) Community Case Management (CCM) (a set of clinical paper based guidelines for treating childhood (> 2 months and < 5 years of age) illness in LMICs), and evaluates the potential of converting it into a mHealth solution. The Supporting Low-cost Intervention For disEase control (LIFE) electronic CCM application (SL eCCM app) is a mHealth decision support tool that digitises clinical guidelines. Its decision support system aims to reduce human error and improve the quality of care for children in rural Malawi. An economic evaluation and statistical tests are proposed to assess and evaluate the SL eCCM app based on results attained from a technical feasibility study. The procedure and key considerations for the economic evaluation are outlined. To date, many mHealth projects never expand beyond small scale pilot projects. The failure to achieve wide scale adoption may, in part, be attributed to the lack of quantitative data demonstrating the value of the technology to respective local governments and other relevant stakeholders.