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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Swaddy day 1, 2, 3
Device
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
Device
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.

Treatment groups

56 Participants

are divided into 2 treatment groups

Group A: Group Swaddy firstActive comparator 1 intervention

Group B: Group Swaddy secondActive comparator 1 intervention

Trial outcomes

Primary outcomes

Comfort B scale

It is a scale validated in pediatrics that assesses the behavioral signs of the newborn. Its maximum value is 30 and its minimum is 6. And the higher score, is the greater the pain or stress.

Time frame