StressSwaddyNCT07270055
Swaddy, a Neonatal Positioning Device.
A study testing Swaddy day 1, 2, 3 and Swaddy day 4, 5, 6 in people with Stress, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 days and older
- Conditions the study is for
- Stress
- What is being tested?
- Swaddy day 1, 2, 3 and Swaddy day 4, 5, 6
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newborns weighing ≤1500 grams at birth admitted to the NICU. • Patients who are in an incubator.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Neonatal Device Swaddy® on the Stress Level of Preterm Newborns: A Randomized Clinical 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.
Read the detailed description
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:
- To evaluate the effect of positional restraint with Swaddy® on the stability of the preterm newborn, through the physiological parameters HR, RF, temperature, and SatO2, compared to standard containment care for 3 consecutive hours.
- To evaluate the safety of the number of apneas, in containment with Swaddy® compared to standard care.
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.
- Conditions
- Stress
- Being tested
- Swaddy day 1, 2, 3, Swaddy day 4, 5, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swaddy day 1, 2, 3Device
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, 6Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Swaddy day 4, 5, 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three hours during the intervention
Secondary outcomes (4)
Heart rate
Heart rate
Measured: three hours during the intervention
Respiratory rate
Respiratory rate
Measured: three hours during the intervention
Oxygen saturation
Oxygen saturation
Measured: three hours during the intervention
Temperature
Temperature
Measured: three hours during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, crossover, multicenter, open-label clinical trial.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270055
- Sponsor's protocol ID
- IIBSP-SWA-2025-35
- Acronym
- Swaddy
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neonatal Device Swaddy® on the Stress Level of Preterm Newborns: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07270055
- Acronym / sponsor ID
- Swaddy / IIBSP-SWA-2025-35
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To evaluate the effect of positional restraint with Swaddy® on the stability of the preterm newborn, through the physiological parameters HR, RF, temperature, and SatO2, compared to standard containment care for 3 consecutive hours.
- To evaluate the safety of the number of apneas, in containment with Swaddy® compared to standard care.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, crossover, multicenter, open-label clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Group Swaddy first | Active comparator | Device: Swaddy day 1, 2, 3In 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). |
| Group Swaddy second | Active comparator | Device: Swaddy day 4, 5, 6In 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. |
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Newborns weighing ≤1500 grams at birth admitted to the NICU. • Patients who are in an incubator.
Key exclusion criteria (3 listed)
- Hemodynamic instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swaddy day 1, 2, 3In 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 | Group Swaddy first |
| Swaddy day 4, 5, 6In 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 | Group Swaddy second |
Primary outcome
Comfort B scale
Time frame: three hours during the intervention
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.
4 secondary outcomes
Heart rate
Time frame: three hours during the intervention
Respiratory rate
Time frame: three hours during the intervention
Oxygen saturation
Time frame: three hours during the intervention
Temperature
Time frame: three hours during the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Swaddy day 1, 2, 3 and Swaddy day 4, 5, 6 in people with Stress, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia VICENTE PÉREZ, Principal Investigator (+34 647531247, svicente@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort B scale (time frame: three hours during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.