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| Name | Class |
|---|---|
| Spanish Clinical Research Network - SCReN | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| facilitated tucking device (FTD) | Experimental | 20 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facilitated tucking device | Procedure | 20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| silvia Vicente PĂ©rez | FundaciĂł de GestiĂł SanitĂ ria de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silvia Vicente PĂ©rez | Castelldefels | Barcelona | 08860 | Spain |
october 2017
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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