Swaddy, a Neonatal Positioning Device.

The objective of this clinical trial is to evaluate the effect of positional restraint on the stress level of preterm newborns, resting in the incubator. The main question sought to be answered is: The stress level of the preterm newborn will decrease with swaddy® containment, compared to standard care, and both with similar safety. Participants will remain in the incubator for 3 consecutive hours and the level of stress in the same patient will be evaluated, one day with containment and another day without containment.

NCT Number	NCT07270055
Lead Sponsor	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Collaborators: Fundació Institut Germans Trias i Pujol
Conditions	Stress
Enrollment	56 participants
Start Date	2025-12
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-08