The P(A)LATE study investigates preoperative screening strategies in infants with Robin sequence (RS). RS is characterized by micrognathia, glossoptosis, and upper airway obstruction (UAO). The majority of infants also present with a cleft palate, for which primary palatoplasty is typically performed around 12 months of age. Postoperative narrowing of the intraoral space is anticipated following palatoplasty, potentially increasing the risk of UAO. In current practice, preoperative polysomnography (PSG) is performed both without and with a palatal plate, the latter simulating the postoperative anatomical situation. However, the added value of conducting PSG with a palatal plate remains unclear, and treatment protocols vary across centers.

This multicenter, prospective, observational, comparative, non-randomized study will evaluate whether preoperative PSG without palatal plate is non-inferior to PSG with palatal plate in predicting perioperative respiratory outcomes. All participating centers will follow their local standard care protocols. Data on preoperative PSG, primary palatoplasty, and postoperative P(S)G will be collected in Castor EDC. The primary endpoint is the difference in perioperative respiratory outcomes between infants undergoing PSG with(out) palatal plate.

By clarifying the role of the palatal plate in preoperative PSG, this study may contribute to greater uniformity in screening practices for infants with RS. Ultimately, the findings could inform recommendations for (inter)national guidelines on the management of RS.