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Objective This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2).Design Multicentre randomised cross-over study.Setting Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator.Patients 39 infants: median gestational age of 27 weeks (IQR: 26–30), postnatal age 7 days (IQR: 2–17), weight 1120 g (IQR: 915–1588), FiO2 0.32 (IQR: 0.22–0.43) receiving both non-invasive (27) and invasive (12) respiratory support.Intervention Randomised sequential 24-hour periods of automated and manual FiO2 control.Main outcome measures Proportion (%) of time in normoxaemia (90%–95% with FiO2>0.21 and 90%–100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes.Results During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p95% with FiO2>0.21 (16%±19% vs 35%±24%) p

Abstract Background Mortality, cerebral injury, and necrotizing enterocolitis (NEC) are common complications of very preterm birth. An important risk factor for these complications is hemodynamic instability. Pre-clinical studies suggest that the timing of umbilical cord clamping affects hemodynamic stability during transition. Standard care is time-based cord clamping (TBCC), with clamping irrespective of lung aeration. It is unknown whether delaying cord clamping until lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) is more beneficial. This document describes the statistical analyses for the ABC3 trial, which aims to assess the efficacy and safety of PBCC, compared to TBCC. Methods The ABC3 trial is a multicenter, randomized trial investigating PBCC (intervention) versus TBCC (control) in very preterm infants. The trial is ethically approved. Preterm infants born before 30 weeks of gestation are randomized after parental informed consent. The primary outcome is intact survival, defined as the composite of survival without major cerebral injury and/or NEC. Secondary short-term outcomes are co-morbidities and adverse events assessed during NICU admission, parental reported outcomes, and long-term neurodevelopmental outcomes assessed at a corrected age of 2 years. To test the hypothesis that PBCC increases intact survival, a logistic regression model will be estimated using generalized estimating equations (accounting for correlation between siblings and observations in the same center) with treatment and gestational age as predictors. This plan is written and submitted without knowledge of the data. Discussion The findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth. Trial registration ClinicalTrials.gov NCT03808051. Registered on 17 January 2019.

Background The quality of registry based studies depends largely on the data accuracy of the registries. The Dutch Perinatal Registry (Perined) is a nationwide database comprising perinatal data digitally provided by different healthcare providers. Perined data are used for comparing outcomes across regions and healthcare institutions as well as for quality analyses and research purposes. However, little is known about the data quality of the Perined database. Therefore, the aim of this study is to assess the quality of Perined data compared to hospital records and case report forms (CRFs) that were part of the IUGR Risk Selection (IRIS) study. Methods In this comparison study data from Perined and the IRIS Study will be used. The IRIS study was a large cluster-randomized trial investigating the effectiveness of routine third trimester ultrasonography in reducing severe adverse perinatal outcomes among Dutch low-risk pregnant women. A subsample of the IRIS study of neonates being at risk of severe adverse perinatal outcomes and their mothers will be used. Baseline demographic data were collected by midwives from participating women at inclusion (around 22 weeks’ gestation) using CRFs, and in-depth neonatal and maternal clinical data were retrieved from hospital records by trained research assistants. These latter IRIS study data were linked and compared to Perined data. Completeness of Perined data will be calculated for every variable. The reliability will be assessed as the percent of agreement between Perined and hospital record data or the CRF-based data. Additionally, intra-class correlation coefficients will be calculated for continuous variables, and Kappa and ‘Prevalence-and-Bias-Adjusted Kappa’ will be calculated for categorical variables. Discussion The results of the proposed comparison study will provide users of Perined data insight in its data quality. This will serve as an example of the accuracy of registry based data used in maternal and neonatal care research.