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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Completed

Conditions: Stress

Treatments: Procedure: Facilitated tucking device

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02944773

IIBSP-EST-2015-97

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 5 to 9 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

facilitated tucking device (FTD)

Experimental group

Description:

20 infants use a FTD in the procedure of daily weight

Treatment:

Procedure: Facilitated tucking device

without FTD

No Intervention group

Description:

20 infants use not a FTD in the procedure of daily weight