Clarity and consistency in stillbirth reporting in Europe: why is it so hard to get this right?

Background Stillbirth is a major public health problem, but measurement remains a challenge even in high-income countries. We compared routine stillbirth statistics in Europe reported by Eurostat with data from the Euro-Peristat research network. Methods We used data on stillbirths in 2015 from both sources for 31 European countries. Stillbirth rates per 1000 total births were analyzed by gestational age (GA) and birthweight groups. Information on termination of pregnancy at ≥22 weeks’ GA was analyzed separately. Results Routinely collected stillbirth rates were higher than those reported by the research network. For stillbirths with a birthweight ≥500 g, the difference between the mean rates of the countries for Eurostat and Euro-Peristat data was 22% [4.4/1000, versus 3.5/1000, mean difference 0.9 with 95% confidence interval (CI) 0.8–1.0]. When using a birthweight threshold of 1000 g, this difference was smaller, 12% (2.9/1000, versus 2.5/1000, mean difference 0.4 with 95% CI 0.3–0.5), but substantial differences remained for individual countries. In Euro-Peristat, missing data on birthweight ranged from 0% to 29% (average 5.0%) and were higher than missing data for GA (0–23%, average 1.8%). Conclusions Routine stillbirth data for European countries in international databases are not comparable and should not be used for benchmarking or surveillance without careful verification with other sources. Recommendations for improvement include using a cut-off based on GA, excluding late terminations of pregnancy and linking multiple sources to improve the quality of national databases.publishedVersio

Management of Mother's Own Milk for Very Preterm Infants in Tertiary-Level Neonatal Units in the Ile-de-France Region in France.: other's own milk for very preterm infants

International audience

Leading causes of preterm delivery as risk factors for intraventricular hemorrhage in very preterm infants: results of the EPIPAGE 2 cohort study

Intraventricular hemorrhage is a major risk factor for neurodevelopmental disabilities in preterm infants. However, few studies have investigated how pregnancy complications responsible for preterm delivery are related to intraventricular hemorrhage

Association Between Early Screening for Patent Ductus Arteriosus and In-Hospital Mortality Among Extremely Preterm Infants

International audienceIMPORTANCE:There is currently no consensus for the screening and treatment of patent ductus arteriosus (PDA) in extremely preterm infants. Less pharmacological closure and more supportive management have been observed without evidence to support these changes.OBJECTIVE:To evaluate the association between early screening echocardiography for PDA and in-hospital mortality.DESIGN, SETTING, AND PARTICIPANTS:Comparison of screened and not screened preterm infants enrolled in the EPIPAGE 2 national prospective population-based cohort study that included all preterm infants born at less than 29 weeks of gestation and hospitalized in 68 neonatal intensive care units in France from April through December 2011. Two main analyses were performed to adjust for potential selection bias, one using propensity score matching and one using neonatal unit preference for early screening echocardiography as an instrumental variable.EXPOSURES:Early screening echocardiography before day 3 of life.MAIN OUTCOMES AND MEASURES:The primary outcome was death between day 3 and discharge. The secondary outcomes were major neonatal morbidities (pulmonary hemorrhage, severe bronchopulmonary dysplasia, severe cerebral lesions, and necrotizing enterocolitis).RESULTS:Among the 1513 preterm infants with data available to determine exposure, 847 were screened for PDA and 666 were not; 605 infants from each group could be paired. Exposed infants were treated for PDA more frequently during their hospitalization than nonexposed infants (55.1% vs 43.1%; odds ratio [OR], 1.62 [95% CI, 1.31 to 2.00]; absolute risk reduction [ARR] in events per 100 infants, -12.0 [95% CI, -17.3 to -6.7). Exposed infants had a lower hospital death rate (14.2% vs 18.5% ; OR, 0.73 [95% CI, 0.54 to 0.98]; ARR, 4.3 [95% CI, 0.3 to 8.3]) and a lower rate of pulmonary hemorrhage (5.6% vs 8.9%; OR, 0.60 [95% CI, 0.38 to 0.95]; ARR, 3.3 [95% CI, 0.4 to 6.3]). No differences in rates of necrotizing enterocolitis, severe bronchopulmonary dysplasia, or severe cerebral lesions were observed. In the overall cohort, instrumental variable analysis yielded an adjusted OR for in-hospital mortality of 0.62 [95% CI, 0.37 to 1.04].CONCLUSIONS AND RELEVANCE:In this national population-based cohort of extremely preterm infants, screening echocardiography before day 3 of life was associated with lower in-hospital mortality and likelihood of pulmonary hemorrhage but not with differences in necrotizing enterocolitis, severe bronchopulmonary dysplasia, or severe cerebral lesions. However, results of the instrumental variable analysis leave some ambiguity in the interpretation, and longer-term evaluation is needed to provide clarity

Cohort Profile: the Etude Epidémiologique sur les Petits Ages Gestationnels-2 (EPIPAGE-2) preterm birth cohort

International audienc

Developing and testing a protocol using a common data model for federated collection and analysis of national perinatal health indicators in Europe

Context: International comparisons of the health of mothers and babies provide essential benchmarks for guiding health practice and policy, but statistics are not routinely compiled in a comparable way. These data are especially critical during health emergencies, such as the coronavirus disease (COVID-19) pandemic. The Population Health Information Research Infrastructure (PHIRI) project aimed to promote the exchange of population data in Europe and included a Use Case on perinatal health. Objective: To develop and test a protocol for federated analysis of population birth data in Europe. Methods: The Euro-Peristat network with participants from 31 countries developed a Common Data Model (CDM) and R scripts to exchange and analyse aggregated data on perinatal indicators. Building on recommended Euro-Peristat indicators, complemented by a three-round consensus process, the network specified variables for a CDM and common outputs. The protocol was tested using routine birth data for 2015 to 2020; a survey was conducted assessing data provider experiences and opinions. Results: The CDM included 17 core data items for the testing phase and 18 for a future expanded phase. 28 countries and the four UK nations created individual person-level databases and ran R scripts to produce anonymous aggregate tables. Seven had all core items, 17 had 13-16, while eight had ≤12. Limitations were not having all items in the same database, required for this protocol. Infant death and mode of birth were most frequently missing. Countries took from under a day to several weeks to set up the CDM, after which the protocol was easy and quick to use. Conclusion: This open-source protocol enables rapid production and analysis of perinatal indicators and constitutes a roadmap for a sustainable European information system. It also provides minimum standards for improving national data systems and can be used in other countries to facilitate comparison of perinatal indicators

Developing and testing a protocol using a common data model for federated collection and analysis of national perinatal health indicators in Europe

Context: International comparisons of the health of mothers and babies provide essential benchmarks for guiding health practice and policy, but statistics are not routinely compiled in a comparable way. These data are especially critical during health emergencies, such as the coronavirus disease (COVID-19) pandemic. The Population Health Information Research Infrastructure (PHIRI) project aimed to promote the exchange of population data in Europe and included a Use Case on perinatal health. Objective: To develop and test a protocol for federated analysis of population birth data in Europe. Methods: The Euro-Peristat network with participants from 31 countries developed a Common Data Model (CDM) and R scripts to exchange and analyse aggregated data on perinatal indicators. Building on recommended Euro-Peristat indicators, complemented by a three-round consensus process, the network specified variables for a CDM and common outputs. The protocol was tested using routine birth data for 2015 to 2020; a survey was conducted assessing data provider experiences and opinions. Results: The CDM included 17 core data items for the testing phase and 18 for a future expanded phase. 28 countries and the four UK nations created individual person-level databases and ran R scripts to produce anonymous aggregate tables. Seven had all core items, 17 had 13-16, while eight had ≤12. Limitations were not having all items in the same database, required for this protocol. Infant death and mode of birth were most frequently missing. Countries took from under a day to several weeks to set up the CDM, after which the protocol was easy and quick to use. Conclusion: This open-source protocol enables rapid production and analysis of perinatal indicators and constitutes a roadmap for a sustainable European information system. It also provides minimum standards for improving national data systems and can be used in other countries to facilitate comparison of perinatal indicators

Perceived maternal information on premature infant's pain during hospitalization: the French EPIPAGE-2 national cohort study.

International audienceBackground Parents of preterm neonates wish greater involvement in pain management; little is known about factors associated with this involvement. We aim to describe perceived maternal information on infants’ pain during hospitalization (PMIP), to study associations between PMIP and mothers’ attitudes during painful procedures, and to identify individual and contextual factors associated with PMIP. Methods Analyses of questionnaires from the French national cohort study of preterm neonates, EPIPAGE-2. PMIP was derived from mothers’ answers to questions about information perceived on both pain assessment and management. Results Among 3056 eligible neonates born before 32 weeks, 1974, with available maternal reports, were included in the study. PMIP was classified as “sufficient,” “little, not sufficient,” or “insufficient, or none” for 22.7, 45.9, and 31.3% of neonates, respectively. Mothers reporting PMIP as “sufficient” were more frequently present and more likely comforting their child during painful procedures. Factors independently associated with “sufficient” PMIP were high maternal education, gestational age <29 weeks, daily maternal visits, perception of high team support, and implementation of the neonatal and individualized developmental care and assessment program. Conclusion Perceived maternal information on premature infants’ pain reported as sufficient increased maternal involvement during painful procedures and was associated with some units’ policies

International versus national growth charts for identifying small and large-for-gestational age newborns: A population-based study in 15 European countries

Background To inform the on-going debate about the use of universal prescriptive versus national intrauterine growth charts, we compared perinatal mortality for small and large-for-gestational-age (SGA/LGA) infants according to international and national charts in Europe. Methods We classified singleton births from 33 to 42 weeks of gestation in 2010 and 2014 from 15 countries (N = 1,475,457) as SGA (birthweight 90th percentile) using the international Intergrowth-21st newborn standards and national charts based on the customised charts methodology. We computed sex-adjusted odds ratios (aOR) for stillbirth, neonatal and extended perinatal mortality by this classification using multilevel models. Findings SGA and LGA prevalence using national charts were near 10% in all countries, but varied according to international charts with a north to south gradient (3.0% to 10.1% and 24.9% to 8.0%, respectively). Compared with appropriate for gestational age (AGA) infants by both charts, risk of perinatal mortality was increased for SGA by both charts (aOR[95% confidence interval (CI)]=6.1 [5.6–6.7]) and infants reclassified by international charts from SGA to AGA (2.7 [2.3–3.1]), but decreased for those reclassified from AGA to LGA (0.6 [0.4–0.7]). Results were similar for stillbirth and neonatal death. Interpretation Using international instead of national charts in Europe could lead to growth restricted infants being reclassified as having normal growth, while infants with low risks of mortality could be reclassified as having excessive growth. Funding InfAct Joint Action, CHAFEA Grant n°801,553 and EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking ConcePTION grant n°821,520. AH received a PhD grant from EHESP