Effects of Prone Positioning on Head Control in Preterm Infants: Randomized and Controlled Clinical Trial Protocol

Purpose: The primary aim will be to assess the effects of prone positioning (tummy time) on cervical extension (angular kinematics and time) in preterm infants. The secondary aim will be to assess the effects of tummy time on gross motor function. Methods: This randomized, controlled clinical trial will include 40 preterm infants weighing less than 2500 g, randomly allocated into control or experimental group (n = 20) and followed up from birth to six months of corrected age by the team of the neonatal follow-up clinic. Caregivers will be routinely guided on bonding, developmental milestones, and how to perform the tummy time for 30 min throughout the day (experimental group). An illustrative booklet will be provided as support material. The hypothesis will be tested using inferential analysis, considering an alpha of 5%. Discussion: We expect tummy time to strengthen cervical muscles needed to overcome gravity, master motor skills, and stimulate the integration between family activity and environmental experiences, considerable challenges to which preterm infants are exposed. Trial registration: Registered in the Brazilian Registry of Clinical Trials (identifier RBR-2nwkr47) on 17 February 2022.