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Clinical Trials/NCT02944773
NCT02944773
Completed
Not Applicable

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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country20 target enrollmentOctober 2016
ConditionsStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
20
Locations
1
Primary Endpoint
Heart rate and breathing rate will be decreased compared to baseline measurement.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • ≤1500 grams newborns
  • a week of life about

Exclusion Criteria

  • Hemodynamic instability requiring vasoactive drugs
  • Phototherapy at the time of the procedure
  • Congenital anomalies.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Behavioral signs(one year)

Study Sites (1)

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