Physiological-based cord clamping for infants with congenital diaphragmatic hernia: a multicentre randomized controlled trial.

Congenital diaphragmatic hernia is the result of a developmental defect in the diaphragm, enabling abdominal organs to migrate to the thoracic cavity thereby interfering with pulmonary development. Most neonates born with a congenital diaphragmatic hernia (CDH) will develop respiratory insufficiency immediately after birth as a result of lung hypoplasia and will need invasive respiratory support. This is often combined with pulmonary hypertension (PH), a main determinant for survival. The etiology of PH is multifactorial and progressive vascular remodeling triggered by high perfusion pressures through the lung may be a potential factor. In this project we aim to investigate the implementation of physiological-based cord clamping (PBCC), i.e. achieving adequate lung aeration and perfusion before clamping of the cord, for infants with a CDH. We hypothesize that this approach is protective for the lung vasculature and thereby reduces the occurrence of PH. We will perform a multicenter randomized controlled trial and the primary outcome will be the occurrence of PH in the first 24 hours after birth.

Adopting a different approach at the time of delivery by using physiological-based cord clamping will protect the lung vasculature and thereby reduce the incidence and/or severity of pulmonary hypertension in the longer term.

Immediately after birth, it is restricted to either PBCC or standard of care. Further care will be according to standard protocol without difference between the two groups.

CDH infants randomized to the intervention group will be stabilized according to physiological-based cord clamping (PBCC). For PBCC a specially designed resuscitation table (the Concord) will be used. Immediately after birth, the infant will be placed on the platform of the Concord, carefully avoiding any traction or pressure on the cord. The neonate will be intubated immediately after transfer to the table and respiratory support will be provided according to current clinical guidelines. The umbilical cord will not be clamped until the infant is stabilised. Stable is defined as the presence of a heart rate above 100 bpm and preductal oxygen saturation above 85% using a FiO2 of <0.5. The minimal and maximum time of cord clamping are three and ten minutes.