Stress
Conditions
Keywords
newborn, facilitated tucking, position, weight, stress
Brief 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 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.
Interventions
PROCEDUREFacilitated tucking device
20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress
Sponsors
Spanish Clinical Research Network - SCReN
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Days to 9 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate and breathing rate will be decreased compared to baseline measurement. | one year | Heart rate (beats / minute)and respiratory rate will decrease significantly during facilitated tucking weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral signs | 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 |
Countries
Spain
Outcome results
None listed