Swaddy, a Neonatal Positioning Device.

NCT07270055 | Not Yet Recruiting DMC

• 1 other identifier: IIBSP-SWA-2025-35
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• 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.

  three hours during the intervention

Secondary Outcomes (4)

• Heart rate

  three hours during the intervention

• Respiratory rate

  three hours during the intervention

• Oxygen saturation

  three hours during the intervention

• Temperature

  three hours during the intervention

Study Arms (2)

Group Swaddy first

ACTIVE COMPARATOR

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

Group Swaddy second

ACTIVE COMPARATOR

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

Interventions

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).

Group Swaddy first

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.

Group Swaddy second

Eligibility Criteria

• Age: 3 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newborns weighing ≤1500 grams at birth admitted to the NICU. • Patients who are in an incubator.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Fundació Institut Germans Trias i Pujol: collaborator

Central Study Contacts

Silvia VICENTE PÉREZ, Principal Investigator

CONTACT

+34 647531247; svicente@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, crossover, multicenter, open-label clinical trial.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share