Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants

Conditions
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Stress

Intervention / Treatment
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* Procedure: Facilitated tucking device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≤1500 grams newborns a week of life about Exclusion Criteria: Surgery Hemodynamic instability requiring vasoactive drugs Sedation Phototherapy at the time of the procedure Congenital anomalies.

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 9 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: facilitated tucking device (FTD)<br>20 infants use a FTD in the procedure of daily weight | Procedure: Facilitated tucking device<br>* 20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress<br>|
| No Intervention: without FTD<br>20 infants use not a FTD in the procedure of daily weight | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newborn, facilitated tucking, position, weight, stress