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

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

SUBMITTER: Horn-Oudshoorn EJJ 

PROVIDER: S-EPMC10953116 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature