StressUTERNCT02944773
Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants
A study testing Facilitated tucking device in people with Stress, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Randomized crossover clinical trial in which is intended to assess the effect of facilitated tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with normal practice, without facilitated… Read more about this study
- Who is it for?
- Ages 5 to 9 days
- Conditions the study is for
- Stress
- What is being tested?
- Facilitated tucking device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 9 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≤1500 grams newborns
- a week of life about
Who cannot join
- Surgery
- Hemodynamic instability requiring vasoactive drugs
- Sedation
- Phototherapy at the time of the procedure
- Congenital anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized crossover clinical trial in which is intended to assess the effect of facilitated tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with normal practice, without facilitated tucking device.
Read the detailed description
Population(n): 20 newborn When a patient is a possible candidate, consent will be asked their parents. After obtaining informed consent signed by parents, it will be assigned a random group (G1, G2). In the G1, the first weight without facilitated tucking device and the next day with facilitated tucking device will be held. G2 will be done in reverse.
Handling pre phase (T0): at least 20 minutes before vitals heart rate and respiratory rate are taken in five times.
handling phase (T1): 1. the facilitated tucking device is placed. 2. will wait five minutes and weight will be held in the incubator;at the time of leaving it in the incubator the same constants are taken.
post handling phase (T2): the same constants are taken one hour after such manipulation.
- Conditions
- Stress
- Being tested
- Facilitated tucking device
- Keywords
- newborn, facilitated tucking, position, weight, stress
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated tucking deviceProcedure or surgery
20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress
| Study group | Role | What they receive |
|---|---|---|
| facilitated tucking device (FTD) | Experimental | 20 infants use a FTD in the procedure of daily weight Receives: Procedure: Facilitated tucking device |
| without FTD | No intervention | 20 infants use not a FTD in the procedure of daily weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate and breathing rate will be decreased compared to baseline measurement.
Heart rate (beats / minute)and respiratory rate will decrease significantly during facilitated tucking weight.
Measured: one year
Secondary outcomes (1)
Behavioral signs
ALPS-Neo scale will decreased significantly during facilitated tucking weight. Evaluate the behaviors: facial expression, respiratory pattern, tone of limbs, activity of hands and feet, and level of activity collected on the scale ALPS-Neo during weight, and compare them with facilitated tucking weight
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017
- Study completionDec 2017
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.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- silvia Vicente Pérez, Principal investigator, Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944773
- Sponsor's protocol ID
- IIBSP-EST-2015-97
- Acronym
- UTER
- Status last verified
- Dec 2017
- First submitted
- 10 Oct 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: october 2017
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants
- ClinicalTrials.gov ID
- NCT02944773
- Acronym / sponsor ID
- UTER / IIBSP-EST-2015-97
- Conditions
- Stress
- Keywords
- newborn, facilitated tucking, position, weight, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Randomized crossover clinical trial in which is intended to assess the effect of facilitated tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with normal practice, without facilitated tucking device.
Detailed description
Population(n): 20 newborn When a patient is a possible candidate, consent will be asked their parents. After obtaining informed consent signed by parents, it will be assigned a random group (G1, G2). In the G1, the first weight without facilitated tucking device and the next day with facilitated tucking device will be held. G2 will be done in reverse.
Handling pre phase (T0): at least 20 minutes before vitals heart rate and respiratory rate are taken in five times.
handling phase (T1): 1. the facilitated tucking device is placed. 2. will wait five minutes and weight will be held in the incubator;at the time of leaving it in the incubator the same constants are taken.
post handling phase (T2): the same constants are taken one hour after such manipulation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| facilitated tucking device (FTD) | Experimental | Procedure: Facilitated tucking device20 infants use a FTD in the procedure of daily weight |
| without FTD | No intervention | –20 infants use not a FTD in the procedure of daily weight |
Who may qualify
- Ages
- 5 to 9 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ≤1500 grams newborns
- a week of life about
Key exclusion criteria (5 listed)
- Surgery
- Hemodynamic instability requiring vasoactive drugs
- Sedation
- Phototherapy at the time of the procedure
- Congenital anomalies.
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 |
|---|---|---|
| Facilitated tucking device20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress | Procedure or surgery | facilitated tucking device (FTD) |
Primary outcome
Heart rate and breathing rate will be decreased compared to baseline measurement.
Time frame: one year
Heart rate (beats / minute)and respiratory rate will decrease significantly during facilitated tucking weight.
1 secondary outcome
Behavioral signs
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No. october 2017
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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. This study is not recruiting at the moment.
silvia Vicente Pérez principal investigator
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated tucking device in people with Stress, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate and breathing rate will be decreased compared to baseline measurement. (time frame: one year). 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 24 Jan 2018.