Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan.

BACKGROUND: Infants born with congenital diaphragmatic hernia (CDH) are at high risk of respiratory insufficiency and pulmonary hypertension. Routine practice includes immediate clamping of the umbilical cord and endotracheal intubation. Experimental animal studies suggest that clamping the umbilical cord guided by physiological changes and after the lungs have been aerated, named physiological-based cord clamping (PBCC), could enhance the fetal-to-neonatal transition in CDH. We describe the statistical analysis plan for the clinical trial evaluating the effects of PBCC versus immediate cord clamping on pulmonary hypertension in infants with CDH (PinC trial). DESIGN: The PinC trial is a multicentre, randomised controlled trial in infants with isolated left-sided CDH, born ≥ 35.0 weeks of gestation. The primary outcome is the incidence of pulmonary hypertension in the first 24 h after birth. Maternal outcomes include estimated maternal blood loss. Neonatal secondary outcomes include mortality before discharge, extracorporeal membrane oxygenation therapy, and number of days of mechanical ventilation. Infants are 1:1 randomised to either PBCC or immediate cord clamping using variable random permutated block sizes (4-8), stratified by treatment centre and estimated severity of pulmonary hypoplasia (i.e. mild/moderate/severe). At least 140 infants are needed to detect a relative reduction in pulmonary hypertension by one third, with 80% power and 0.05 significance level. A chi-square test will be used to evaluate the hypothesis that PBCC decreases the occurrence of pulmonary hypertension. This plan is written and submitted without knowledge of the collected data. The trial has been ethically approved. TRIAL REGISTRATION: ClinicalTrials.gov NCT04373902 (registered April 2020).

Development of a competency profile for professionals involved in infectious disease preparedness and response in the air transport public health sector.

BACKGROUND: Recent infectious disease outbreaks highlight the importance of competent professionals with expertise on public health preparedness and response at airports. The availability of a competency profile for this workforce supports efficient education and training. Although competency profiles for infectious disease control professionals are available, none addresses the complex airport environment. Therefore, the main aim of this study is to develop a competency profile for professionals involved in infectious disease preparedness and response at airports in order to stimulate and direct further education and training. METHODS: We developed the competency profile through the following steps: 1) extraction of competencies from relevant literature, 2) assessment of the profile in a national RAND modified Delphi study with an interdisciplinary expert group (n = 9) and 3) assessment of the profile in an international RAND modified Delphi study with an airport infectious disease management panel of ten European countries (n = 10). RESULTS: We systematically studied two competency profiles on infectious disease control and three air transport guidelines on event management, and extracted 61 relevant competencies for airports. The two RAND modified Delphi procedures further refined the profile, mainly by specifying a competency's target group, the organizational level it should be present on, and the exact actions that should be mastered. The final profile, consisting of 59 competencies, covers the whole process from infectious disease preparedness, through the response phase and the recovery at airports. CONCLUSION: We designed a profile to support training and exercising the multidisciplinary group of professionals in infectious disease management in the airport setting, and which is ready for use in practice. The many adaptations and adjustments that were needed to develop this profile out of existing profiles and air transport guidelines suggest that other setting-specific profiles in infectious disease control are desirable.