Swaddy, a Neonatal Positioning Device.
ConditionStress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About this trial
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.
Eligibility criteria
Qualifiers
Newborns weighing ≤1500 grams at birth admitted to the NICU. • Patients who are in an incubator.
Disqualifiers
Hemodynamic instability.
Be a carrier of CPAP or nasal BIPAP with a cap (because the CPAP/BIPAP already has a built-in cap, just like Swaddy).
Be in treatment with phototherapy.
Trial design
Treatments tested in this trial
- Swaddy day 1, 2, 3
- Swaddy day 4, 5, 6
Treatment groups
56 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Fundació Institut Germans Trias i Pujol
Collaborator
Source ClinicalTrials.gov