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
Erasmus MC University Medical Center. Leiden University Medical Center. Monash University, Melbourne. University Medical Center Mannheim. Radboudumc University Medical Center and Amalia Children’s Hospital. University Hospitals Leuven. Medical University of Graz. University of Bonn Children’s Hospital. Bambino Gesu Children’s Hospital. Karolinska University Hospital. University of Toronto.
Netherlands, Australia, Germany, Belgium, Austria, Italy, Sweden and Canada
Trials
Trials 2024; 25:
DOI: 10.1186/s13063-024-08027-7
Abstract
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.
Category
Class III. Pulmonary Hypertension Associated with Lung Hypoplasia
Age Focus: Pediatric Pulmonary Vascular Disease
Fresh or Filed Publication: Fresh (PHresh). Less than 1-2 years since publication
Article Access
Free PDF File or Full Text Article Available Through PubMed or DOI: Yes