Physiological-Based Cord Clamping and Early Oxygenation in Newborns With Transposition of the Great Arteries: A Quality Improvement Study Protocol

<h2>Abstract</h2> At birth, major circulatory and pulmonary adaptations are required for a successful foetal-to-neonatal transition. In newborns with transposition of the great arteries (TGA), this transition is often impaired, leading to severe hypoxemia. This may also result in persistent pulmonary hypertension of the newborn (PPHN), worsening hypoxemia, and increasing the risk of urgent invasive interventions after birth. Physiological-based cord clamping (PBCC), delaying cord clamping until after lung aeration and ventilation are established, promotes a more stable circulatory transition and has shown benefits in both preterm and term neonates. PBCC may also provide advantages in infants with congenital heart disease. In TGA, combining PBCC with early supplemental oxygen may reduce the incidence and severity of PPHN, decrease related complications, and minimize the need for invasive interventions. To evaluate the feasibility, safety, and clinical outcomes of the stabilisation approach, we have initiated a stepwise quality improvement initiative comprising 2 sequential studies. Study phase 1, a single-centre study at Leiden University Medical Centre will assess feasibility, protocol adherence, and safety. Study phase 2, an observational cohort study across multiple European centres will evaluate clinical outcomes, focusing on incidence and severity of PPHN and the need for urgent interventions. All TGA newborns will be stabilised with an intact umbilical cord while receiving 2 L/min nasal high flow (fraction of inspired oxygen 1.0) as supplemental oxygen. Cord clamping will occur once the infant is considered stable, defined as a heart rate >100 bpm and preductal SpO₂ >75% with supplemental oxygen. This study will inform guidelines for delivery room management and early preoperative care in TGA newborns.