Clinical Research Directory
Browse clinical research sites, groups, and studies.
Swaddy, a Neonatal Positioning Device.
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Summary
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.
Official title: Effect of Neonatal Device Swaddy® on the Stress Level of Preterm Newborns: A Randomized Clinical Trial.
Key Details
Gender
All
Age Range
3 Days - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-12
Completion Date
2027-12
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
Swaddy day 1, 2, 3
In Group 1, on the first day (day 1), the first measurement (baseline) will be made. Subsequently, the Swaddy® containment device will be placed and the containment will be maintained for 3 hours, in which the same variables will be measured: Heart Rate (HR), Respiratory Rate (RF), temperature, O2 Saturation (SatO2) and pain scale at 60, 120 and 180 minutes. This procedure will be repeated on day 2 and 3. On day 4, the same measurements will be carried out using standard containment care. This procedure will be repeated on days 5 and 6 (all three at approximately the same time of day as in the intervention).
Swaddy day 4, 5, 6
In Group 2, on the first day (day 1), the first measurement (baseline) will be taken. Subsequently, the patient will be kept in an incubator for 3 hours, in which the following variables will be measured: Heart Rate (HR), Respiratory Rate (RF), temperature, O2 Saturation (SatO2) and pain scale at 60, 120 and 180 minutes, using standard containment care. This procedure will be repeated on day 2 and 3. On day 4, the same measurements will be carried out by applying containment with the Swaddy® device and will be repeated on days 5 and 6.