Emily J J Horn-Oudshoorn, Marijn J Vermeulen, Ronny Knol, Rebekka Bout-Rebel, Arjan B Te Pas, Stuart B Hooper, Suzan C M Cochius-den Otter, Rene M H Wijnen, Kelly J Crossley, Neysan Rafat, Thomas Schaible, Willem P de Boode, Anne Debeer, Berndt Urlesberger, Calum T Roberts, Florian Kipfmueller, Irma Capolupo, Carmen M Burgos, Bettina E Hansen, Irwin K M Reiss, Philip L J DeKoninck
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)...
March 20, 2024: Trials