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Swaddy, a Neonatal Positioning Device.

NCT07270055 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

DEVICE

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).

DEVICE

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.

Sponsors & Collaborators

  • Fundació Institut Germans Trias i Pujol

    collaborator OTHER

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07270055 on ClinicalTrials.gov