Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants (UTER)
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|ClinicalTrials.gov Identifier: NCT02944773|
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress||Procedure: Facilitated tucking device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||December 2017|
Experimental: facilitated tucking device (FTD)
20 infants use a FTD in the procedure of daily weight
Procedure: Facilitated tucking device
20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress
No Intervention: without FTD
20 infants use not a FTD in the procedure of daily weight
- 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.
- Behavioral signs [ Time Frame: one year ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944773
|Silvia Vicente Pérez|
|Castelldefels, Barcelona, Spain, 08860|
|Principal Investigator:||silvia Vicente Pérez||Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau|