An interventional study of Swaddy day 1, 2, 3 and Swaddy day 4, 5, 6 in Stress, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Not yet recruiting. Open to participants aged 3 Days and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Prevention
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.
Primary objective: To assess the effect of Swaddy® containment on the stress level of newborns ≤1500 grams at birth admitted to a NICU, using the Comfort B Scale, for a maximum period of 3 consecutive hours, compared to standard containment care.
Secondary objectives:
Swaddy®, is an adjustable garment of clothing, with a built-in cap, which favors the symmetry of limbs with midline of the body and the hand-to-hand and hand-to-mouth position of preterm newborns, very conciliatory positions for these patients. Its fabric is thin and soft, to prevent overheating, and elastic, to favor the flexor position and allow some mobility. It is a device designed by the IP of the project, registered and patented by the Institut de Recerca Sant Pau, and currently marketed.
In this project, patients will be randomized into two groups. 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). In Group 2, it will be done in reverse.
Vital signs HR, RF, oxygen saturation will be measured with the patient's monitor and temperature with a skin sensor in the incubator itself, which will be located in the patient's thoracoabdominal area.
To assess the safety of the device, the number of apneas of prematurity performed with Swaddy® containment and standard care will be recorded.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hemodynamic instability.
In this project, patients will be randomized into two groups. 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).
Device: Swaddy day 1, 2, 3
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.
Device: Swaddy day 4, 5, 6
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).
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.
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: three hours during the intervention
Heart rate
Heart rate
Time frame: three hours during the intervention
Respiratory rate
Respiratory rate
Time frame: three hours during the intervention
Oxygen saturation
Oxygen saturation
Time frame: three hours during the intervention
Temperature
Temperature
Time frame: three hours during the intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau